MedImmune’s MEDI9197 Activates Immune System To Fight Tumors

MedicalResearch.com Interview with:

Dr. Koustubh Ranade, Vice President of Research & Development Translational Medicine MedImmune

Dr. Ranade

Dr. Koustubh Ranade, PhD
Vice President of Research & Development Translational Medicine
MedImmune

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In a healthy person, abnormal cells including cancer cells are typically detected and destroyed by the immune system in response to danger signals activated by the abnormal cells. However, some solid tumors avoid triggering danger signals, and thus the immune system cannot recognize and destroy cancer cells, permitting tumor growth. To help activate the patient’s immune system to fight these “hidden” cancer cells, MedImmune scientists have developed MEDI9197, a TLR 7/8 agonist, to trigger the needed danger signals.

Our latest data from the Phase 1 study of MEDI9197 demonstrated that through intratumor injection, the therapy binds to TLR7 and TLR8 receptors and activates dendritic cells, which call in other immune cells to fight the tumor.

Continue reading

Treatment With Tremfya® (Guselkumab) Improved Psoriatic Arthritis Symptoms Through One Year

MedicalResearch.com Interview with:

Atul A. Deodhar, MD, MRCP, FACP, FACR Professor of Medicine Division of Arthritis & Rheumatic Diseases Medical Director, Rheumatology Clinics Medical Director, Immunology Infusion Center Oregon Health & Science University (OHSU) 

Dr. Deodhar

Atul A. Deodhar, MD, MRCP, FACP, FACR
Professor of Medicine
Division of Arthritis & Rheumatic Diseases
Medical Director, Rheumatology Clinics
Medical Director, Immunology Infusion Center
Oregon Health & Science University (OHSU) 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The Phase 2, randomized, double-blind, placebo–controlled, multicenter trial was designed to evaluate the efficacy and safety of guselkumab (Tremfya®) compared with placebo in adults with active psoriatic arthritis, despite having received treatment with standard-of-care therapies, including anti-tumor necrosis factor (TNF)-alpha agents.

In an observed analysis presented at ACR 2017, more than 70 percent of patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) at week 56.  Findings also showed that improvements in tender and swollen joints, skin clearance, pain and physical function, and patient-reported quality of life outcomes reported at week 24, were maintained through week 56 in patients receiving guselkumab maintenance therapy (subcutaneous injections every eight weeks).  Continue reading

IPF: Combination of Nintedanib and Pirfenidone May Have Added Benefit With Manageable Side Effects

MedicalResearch.com Interview with:

Professor Carlo Vancheri Professor of Respiratory Medicine, University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.

Prof. Vancheri

Professor Carlo Vancheri
Professor of Respiratory Medicine,
University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: The aim of Boehringer Ingelheim’s INJOURNEY trial was to investigate the safety profile of Ofev (nintedanib) in combination with pirfenidone in treating patients with idiopathic pulmonary fibrosis (IPF). Nintedanib and pirfenidone, the only two FDA-approved drugs for the treatment of IPF, are able to slow down the progression of the disease, reducing the forced vital capacity (FVC) decline of about 50%, but this is not a cure. The target for the future is to have even more effective treatments. In the meanwhile, it is necessary to optimize the use of the available drugs. The medical treatment of other pulmonary diseases such as COPD, asthma or pulmonary hypertension is already based on different combinations of drugs.

This 12-week, open-label, randomized study was designed to evaluate the safety, tolerability and pharmacokinetics of nintedanib with add-on pirfenidone, compared with nintedanib alone in patients with IPF. Change in FVC, the established efficacy endpoint in IPF trials, was evaluated as an exploratory endpoint.

The primary endpoint of the INJOURNEY trial was the percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12 of randomized treatment, and the results showed that the combination of nintedanib and add-on pirfenidone resulted in a manageable safety and tolerability profile, similar to the profile of each drug individually in the majority of patients. Results also indicated there may be a slower decline in FVC in patients treated with pirfenidone along with nintedanib compared with nintedanib alone, suggesting a potential benefit of the combination. However, further research will be necessary to fully evaluate the efficacy of the combination.

Continue reading

Pembrolizumab Reduces Death Rate in Head and Neck Squamous Cell Carcinoma

MedicalResearch.com Interview with:

Ezra Cohen, MD Associate Director, Moores Cancer Center Professor of Medicine Moores Cancer Center UC San Diego Health - La Jolla Moores Cancer Center La Jolla, CA  92093

Dr. Cohen

Ezra Cohen, MD
Associate Director, Moores Cancer Center
Professor of Medicine
Moores Cancer Center
UC San Diego Health – La Jolla
Moores Cancer Center
La Jolla, CA  92093

MedicalResearch.com: What is the background for this study?

Response: We have known for a couple of years that anti-PD1 therapy, and specifically pembrolizumab, is active in  head and neck squamous cell carcinoma (HNSCC). The KN40 trial now tested pembrolizuamb against standard of care in patients whose cancers progressed on platinum containing regimens.

MedicalResearch.com: What are the main findings?

Response: The main findings really supported what we know about pembrolizumab in this disease – it is active and effective with a favorable side effect profile. Pembrolizumab reduced the risk of death by 19% and was associated with a 14% response rate. The effect was even greater in tumors that expressed PDL1 and, in the highest expressing group, the benefit in reduction of risk of death was 46% with a 27% response rate.

Continue reading

Targeted Immunotherapy Can Prevent Some Melanomas From Spreading

MedicalResearch.com Interview with:

Dr Alexander Menzies BSc(Med) MBBS (Hons) FRACP PhD Medical Oncologist and Senior Research Fellow at Melanoma Institute Australia The University of Sydney and Royal North Shore and Mater Hospital 

Dr. Menzies

Dr Alexander Menzies BSc(Med) MBBS (Hons) FRACP PhD
Medical Oncologist and Senior Research Fellow at Melanoma Institute Australia
The University of Sydney and Royal North Shore and Mater Hospital 

MedicalResearch.com: What is the background for this study?

Response: For early-stage melanoma, surgical resection is the standard treatment and is associated with an excellent long-term prognosis. However until now, Stage III melanoma patients (where the disease has spread to the lymph nodes) who have had their tumours surgically removed have simply had to play the waiting game to see if their melanoma would metastasise, with many ultimately dying of the disease.

Checkpoint inhibitor immunotherapies and drugs that target the mitogen-activated protein kinase (MAPK) pathway have improved the outcome of patients with metastatic melanoma, but their role as adjuvant therapy is still being actively investigated.

Prior Phase III trials (COMBI-D and COMBI-V) have shown improved overall survival in patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. At Melanoma Institute Australia, we were keen to see if this improvement would be seen in the adjuvant setting also. This clinical trial was the first in the world to give targeted therapy to melanoma patients at an earlier stage of the disease to prevent spread and recurrence.

Continue reading

Nivolumab Is A Major Advance For Excised Melanoma At Risk of Relapse

MedicalResearch.com Interview with:

Jeffrey Weber, M.D., Ph.D Laura and Isaac Perlmutter Cancer Center New York University Langone Medical Center New York, NY 10016

Dr. Weber

Jeffrey Weber, M.D., Ph.D
Laura and Isaac Perlmutter Cancer Center
New York University Langone Medical Center
New York, NY 10016 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is a major unmet need for well tolerated and effective adjuvant therapy for high risk melanoma, that is, melanoma that has been removed but the patients have a 50%+ risk of relapse over 5 years, and a 50%+ risk of death over 10 years from melanoma. Since nivolumab is an active and well tolerated drug in metastatic disease, it seemed reasonable to test it after surgery to prevent recurrence. Since ipilimumab is approved for resected stage III melanoma in the US as adjuvant therapy, that was the control arm for comparison, and that is an active control, which prolongs relapse free and overall survival comared to placebo.

Continue reading

Study Identifies CD70 as a Novel Glioblastoma Target

MedicalResearch.com Interview with:

Jianping Huang, MD, PhD Associate Professor Director of Clinical Laboratory Operations UF Brain Tumor Immunotherapy Program Department of Neurosurgery, University of Florida

Dr. Huang

Jianping Huang, MD, PhD
Associate Professor
Director of Clinical Laboratory Operations
UF Brain Tumor Immunotherapy Program
Department of Neurosurgery, University of Florida

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Identification and validation of molecules that are involved in tumor progression and reduced survival in glioma patients is the starting point for developing active, safe and effective therapy. Unfortunately, very few target molecules have been identified for the deadly disease of glioma up until recently. Our studies have identified that the molecule CD70 is ectopically expressed on gliomas and involved in promoting glioma progression. Our research shows that CD70 leads to a “double jeopardy” scenario in Glioblastoma (GBM) patients by promoting tumor aggressiveness and inhibiting our immune response to cancer. These results provide a strong scientific rationale to target CD70 using state-of-the-art therapeutic approaches, such as chimeric antigen receptor (CAR) T cell therapy.

Continue reading

Study Reports Hair Repigmentation During Immunotherapy For Lung Cancer

MedicalResearch.com Interview with:
Dr. Noelia Rivera MD

Dermatologist
Hospital Universitari Germans Trias i Pujol, Badalona
Universitat Autònoma de Barcelona

MedicalResearch.com: What is the background for this study?

Response: In the last few years some new therapies targeting immune checkpoints have been developed. The programmed death receptor-1 (PD-1) are immune checkpoints that prevent the immune system to act against own tissues. By blocking these mediators it is possible to prevent tumors to escape from the immune system.

About half of the patients receiving these therapies will develop mild to moderate cutaneous adverse events. In the pre-authorization studies for malignant melanoma these include rash, vitiligo, and pruritus. “Rash” has commonly been reported as an adverse event in many oncologic trials evaluating the drugs, without providing further information about the clinical or histological details. Lately, lichenoid eruptions associated to these therapies have been reported and it suggests that an important percentage of these reactions present lichenoid histological features.

Continue reading

Combination Therapy With DARZALEX® (daratumumab) Provides Clinical Benefit In Relapsed Myeloma

MedicalResearch.com Interview with:

Dr. Ajai Chari, MD Associate Professor of Medicine Multiple Myeloma Program and Associate Director of Clinical Research Mount Sinai Hospital, New York

Dr. Ajai Chari

Dr. Ajai Chari, MD
Associate Professor of Medicine
Multiple Myeloma Program and
Associate Director of Clinical Research
Mount Sinai Hospital, New York

MedicalResearch.com: What is the background for this study? Would you briefly explain multiple myeloma (How common is it, whom does it chiefly affect, etc.)?

Response: Multiple myeloma is a rare form of blood cancer that occurs when plasma cells grow uncontrollably in the bone marrow. It is estimated that approximately 30,280 people will be diagnosed and 12,590 will die from the disease in the United States in 2017. While some patients with multiple myeloma have no symptoms at all, symptoms can include bone fracture or pain, low red blood counts, fatigue, calcium elevation, kidney problems or infections. Despite tremendous progress, most patients with multiple myeloma continually relapse or become resistant to available therapies, such as proteasome inhibitors (PIs) and immunomodulatory agents. Therefore, these patients continue to need new options.

The MMY1001 (EQUULEUS) study is a Phase 1b, open-label study assessing daratumumab in combination with multiple backbone regimens for multiple myeloma. In one arm of the study, supporting the recent approval of DARZALEX (daratumumab), the treatment was assessed in combination with pomalidomide and dexamethasone in patients with multiple myeloma who had received a prior PI and an immunomodulatory agent. Data from the study showed that the addition of daratumumab resulted in an overall response rate (ORR) of 59.2 percent (95 percent CI: 49.1 percent, 68.8 percent), with very good partial response (VGPR) achieved in 28.2 percent of patients. Complete response (CR) was achieved in 5.8 percent of patients and stringent CR (sCR) was achieved in 7.8 percent of patients.

Continue reading

Pembrolizumab – Keytruda- Shows Promise in Subset of Triple Negative Breast Cancer

MedicalResearch.com Interview with:

Sylvia Adams, MD Associate Professor of Medicine Breast Cancer and Cancer Immunotherapy Programs NYU Langone Medical Center Cancer Institute/Clinical Cancer Center New York, NY 10016

Dr. Adams

Sylvia Adams, MD
Associate Professor of Medicine
Breast Cancer and Cancer Immunotherapy Programs
NYU Langone Medical Center
Cancer Institute/Clinical Cancer Center
New York, NY 10016

 

MedicalResearch.com: What is the background for the Keynote-086 trial ? What are the main findings?

Response: This study is the largest immunotherapy study to date presented in metastatic triple negative breast cancer. This phase 2 trial studied the efficacy and safety of pembrolizumab (P) as single agent in a very aggressive disease and had two cohorts, a cohort of previously untreated patients (Cohort B) and a cohort with patients who had received prior chemotherapy lines in the metastatic setting (Cohort A).

The study showed that single agent pembrolizumab can elicit durable responses in a subset of patients. This was found regardless of tumoral PD-L1 expression but appeared to be much more frequent in women without prior chemotherapy treatments in the metastatic setting. Survival is especially promising for patients responding to therapy.

Continue reading

Merkel Cell Carcinoma: Promising Treatment With Combination of T cells and PD-1 Blockade

MedicalResearch.com Interview with:
Dr. Kelly Garneski Paulson, MD, PHD
Fred Hutchinson Cancer Research Center
Seattle, WA  

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Merkel cell carcinoma (MCC) is an aggressive skin cancer with increasing impact. Currently, there are more than 2000 new cases of MCC diagnosed each year in the US. Over one third of patients will develop metastatic disease.

Most cases of Merkel cell carcinoma are caused by a virus (Merkel cell polyomavirus). In these cancers, the viral oncoproteins (cancer causing proteins) are highly expressed (exclusively on tumor tissue), immunogenic and are necessary for cancer growth.  These oncoproteins are thus ideal targets for cancer immunotherapy, making MCC a great cancer in which to study and develop immunotherapy.  Indeed, immunotherapies are effective in MCC, with observed response to checkpoint inhibitor mono therapy on the order of 35-55%, although complete responses remain rare.

In our first trial, we treated four patients with metastatic Merkel cell carcinoma with endogenous T cell therapy (ex vivo expanded polyclonal T cells recognizing Merkel cell polyomavirus). One patient developed a complete response, but three patients rapidly progressed. Interestingly, we observed that the patient with the complete response had low levels of PD-1 expression on the virus specific transferred T cells. We thus hypothesized adding adding an immune checkpoint inhibitor (avelumab, anti-PD-L1) to the transferred T cells would be acceptably safe and potentially improve clinical effectiveness.

Continue reading

Report of Benign Moles Undergoing Immune Reaction During Nivolumab Therapy in a Patient With Melanoma

MedicalResearch.com Interview with:

Yasuhiro Nakamura, M.D., Ph.D. Associate Professor Department of Skin Oncology/Dermatology Comprehensive Cancer Center Saitama Medical University International Medical Center Hidaka, Saitama

Dr. Nakamura

Yasuhiro Nakamura, M.D., Ph.D.
Associate Professor
Department of Skin Oncology/Dermatology
Comprehensive Cancer Center
Saitama Medical University International Medical Center
Hidaka, Saitama

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Regressing nevi, which are frequently associated with halo phenomenon, occur in approximately 1% of the general population. In patients with melanoma, spontaneous or treatment-related depigmentation of the skin (vitiligo) is sometimes observed. Although humoral and cellular immune responses may play a crucial role in their development, immune reactions to benign melanocytic nevi (BMN) without a halo are extremely rare in both the general population and in patients with melanoma.

This publication reports a rare case with multiple metastatic melanomas who showed a remarkable clinical response to nivolumab with a simultaneous prominent immune reaction to multiple BMN without halo phenomenon. This rare phenomenon may be associated with dramatic efficacy of nivolumab in melanoma patients.

Continue reading

Tofacitinib -XELJANZ: Potential New Treatment Option For Moderate To Severe Ulcerative Colitis

MedicalResearch.com Interview with:

William J. Sandborn, MD Professor of Medicine and Adjunct Professor of Surgery Chief, Division of Gastroenterology Vice Chair for Clinical Operations, Department of Medicine Director, UCSD IBD Center University of California San Diego and UC San Diego Health System

Dr. Sandborn

William J. Sandborn, MD
Professor of Medicine and Adjunct Professor of Surgery
Chief, Division of Gastroenterology
Vice Chair for Clinical Operations, Department of Medicine
Director, UCSD IBD Center
University of California San Diego and
UC San Diego Health System

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is still a substantial unmet need for new treatments for patients with ulcerative colitis.

A previous Phase II study had suggested that tofacitinib might be effective for short term therapy of ulcerative colitis. The patients in that study for the most part had not failed anti-TNF therapy. Now we report the findings from 3 large Phase III trials, two short term trials and one long term trial, demonstrating that tofacitinib 10 mg twice daily is effective for short term therapy, and that both 5 mg and 10 mg twice daily is effective for long term therapy. We also demonstrated that tofacitinib is effective both in patients who have not failed anti-TNF therapy and patients who have failed anti-TNF therapy.

The study demonstrated induction of clinical remission, clinical response and mucosal healing (flexible sigmoidoscopy improvement) over the short term, and maintenance of clinical remission, clinical response, and mucosal healing over the long term.

Continue reading

Granzyme B Probe Plus PET Scanning Helps Determine Response To Immunotherapy

MedicalResearch.com Interview with:

Ben Larimer, PhD research fellow in lab of Umar Mahmood, MD, PhD Massachusetts General Hospital Professor, Radiology, Harvard Medical School

Dr. Ben Larimer

Ben Larimer, PhD research fellow in lab of
Umar Mahmood, MD, PhD

Massachusetts General Hospital
Professor, Radiology, Harvard Medical School

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:
Although immunotherapies such as checkpoint inhibitors have revolutionized cancer treatment, unfortunately they only work in a minority of patients. This means that most people who are put on a checkpoint inhibitor will not benefit but still have the increased risk of side effects. They also lose time they could have spent on other therapies. The ability to differentiate early in the course of treatment patients who are likely to benefit from immunotherapy from those who will not greatly improves individual patient care and helps accelerate the development of new therapies.

The main purpose of our study was to find a way to separate immunotherapy responders from non-responders at the earliest time point possible, and develop an imaging probe that would allow us to distinguish this non-invasively.

Granzyme B is a protein that immune cells use to actually kill their target. They keep it locked up in special compartments until they get the right signal to kill, after which they release it along with another protein called perforin that allows it to go inside of tumor cells and kill them. We designed a probe that only binds to granzyme B after it is released from immune cells, so that we could directly measure immune cell killing. We then attached it to a radioactive atom that quickly decays, so we could use PET scanning to noninvasively image the entire body to see where immune cells were actively releasing tumor-killing granzyme B.

We took genetically identical mice and gave them identical cancer and then treated every mouse with checkpoint inhibitors, which we knew would result in roughly half of the mice responding, but we wouldn’t know which ones until their tumors began to shrink. A little over a week after giving therapy to the mice, and before any of the tumors started to shrink, we injected our imaging probe and performed PET scans. When we looked at the mice by PET imaging, they fell into two groups. One group had high PET uptake, meaning high levels of granzyme B in the tumors, the other group had low levels of PET signal in the tumors. When we then followed out the two groups, all of the mice with high granzyme B PET uptake ended up responding to the therapy and their tumors subsequently disappeared, whereas those with low uptake had their tumors continue to grow.

We were very excited about this and so we expanded our collaboration with co-authors Keith Flaherty and Genevieve Boland to get patient samples from patients who were on checkpoint inhibitor therapy to see if the same pattern held true in humans. When we looked at the human melanoma tumor samples we saw the same pattern, high secreted granzyme levels in responders and much lower levels in non-responders.

Continue reading

Immunotherapy Ruxolitinib Cream Improves Facial Vitiligo

MedicalResearch.com Interview with:

David Rosmarin, MD Dermatologist; Assistant Professor Tufts University School of Medicine

Dr. Rosmarin

David Rosmarin, MD
Dermatologist; Assistant Professor
Tufts University School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Vitiligo is a disease where the immune system causes depigmentation of the skin. We performed a pilot study to evaluate the use of a new class of medication for the treatment of vitiligo.


MedicalResearch.com: What should readers take away from your report?

Response: After applying topical ruxolitinib cream twice a day, patients had significant repigmentation, particularly those with facial vitiligo.

This treatment holds promise as a potential new treatment for vitiligo. Because it is a topical, it spares many side effects of taking a medication orally.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

Higher Dose IPI for Some Advanced Melanoma Patients?

MedicalResearch.com Interview with:

Dr Paolo A Ascierto MD Melanoma Cancer Immunotherapy and Innovative Therapy Unit Istituto Nazionale Tumori Fondazione Naples Italy

Dr. Ascierto

Dr Paolo A Ascierto MD
Melanoma Cancer Immunotherapy and Innovative Therapy Unit
Istituto Nazionale Tumori Fondazione
Naples Italy

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Although IPI was approved for the treatment of melanoma at dosage of 3 mg/kg, a dose-ranging phase 2 trial suggested longer overall survival (OS) but more treatment-related adverse events with ipilimumab 10 mg/kg vs 3 mg/kg. However, the study MDX010-020 (randomized phase III study which compared ipilimumab 3 mg/kg + gp100 vaccination and ipilimumab 3mg/kg + placebo vs gp100 vaccination + placebo) performed as second line treatment of advanced melanoma patients, showed an OS curve similar to that of the study CA184-169 (randomized phase III study which compared dacarbazine + ipilimumab 10 mg/kg to dacarbazine + placebo) as first line treatment of metastatic melanoma.

For this reason FDA approved ipilimumab at dosage of 3 mg/kg as first and second line treatment for advanced melanoma, but asked for a randomized phase III study of comparison of ipilimumab at the different dosage in order to explore if there was a difference in the outcome of patients with different dosages.

Continue reading

Secukinumab Provides Sustained Improvements in Dermatology-Specific Quality of Life in Moderate to Severe Psoriasis Patients Through 3 Years of Treatment

MedicalResearch.com
Eric Hughes
Global Development Franchise Head Immunology & Dermatology
Novartis

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Psoriasis is a chronic immune-mediated inflammatory disease that negatively impacts patients’ quality of life (QOL); therefore QOL outcomes are increasingly recognized as an important measure of efficacy in psoriasis, complementing traditional measures of severity such as the Psoriasis Area and Severity Index (PASI).

Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile.

Biologic therapies for psoriasis have previously been associated with a fall-off in efficacy over time; accordingly, extended follow-up is required to adequately evaluate novel therapeutic strategies like IL-17A inhibition. Recently, results from the extension of the SCULPTURE secukinumab trial showed that high responses initially achieved with secukinumab at year 1 in the SCULPTURE study were sustained over time up to 3 years with no new or unexpected safety concerns. In this analysis, we examined whether the sustained efficacy observed in SCULPTURE up to 3 years was translated into sustained effect of secukinumab on patient’s QOL measured by the Dermatology Life Quality Index (DLQI) questionnaire.

SCULPTURE, a multi-center extension study, was conducted with subjects who completed 52 weeks of treatment. Subjects were randomized into two maintenance dosing regimens; a fixed-interval schedule of secukinumab 300 mg every 4 weeks (Fixed interval dosing regimen (FI) cohort), and secukinumab retreatment-as-needed (Retreatment as needed (RAN) cohort), in which subjects received placebo until start of relapse, at which time secukinumab 300 mg every 4 weeks was re-initiated.

The analysis using as-observed data showed that at Year 3, improvements in the total score on DLQI was well sustained in both FI and RAN cohorts. Approximately two-thirds of the subjects in the FI cohort reported no impact of skin disease on QOL (corresponding to a score of 0 or 1 on DLQI). The proportion of patients in the RAN cohort reporting no impact of the disease on their QOL was well sustained through 3 years but remained consistently lower than those observed in the FI cohort. The results for each subscale of the DLQI questionnaire were consistent with those with DLQI total score i.e. showing high and sustained proportions of patients reporting no impact of the disease on different domains of health-related QOL in the two secukinumab cohorts with greater effect in the FI cohort compared to the RAN cohort.

Continue reading

Safer Immunotherapy Dupilumab (Dupixent) FDA Approved For Atopic Dermatitis

MedicalResearch.com Interview with:

Emma Guttman, MD, PhD Professor, Dermatology, Medicine and Clinical Immunology Vice Chair of Research in the Dermatology Department Director of the center for Excellence  Eczema in the Occupational/Contact Dermatitis clinic  Director of the Laboratory of Inflammatory Skin Diseases Icahn School of Medicine at Mount Sinai Medical Center New York

Dr. Guttman

Emma Guttman, MD, PhD
Professor, Dermatology, Medicine and Clinical Immunology
Vice Chair of Research in the Dermatology Department
Director of the center for Excellence
Eczema in the Occupational/Contact Dermatitis clinic
Director of the Laboratory of Inflammatory Skin Diseases
Icahn School of Medicine at Mount Sinai Medical Center
New York

MedicalResearch.com: Would you briefly explain what is meant by atopic dermatitis? How many people are affected by this disorder?

Response: Atopic dermatitis or eczema as most people know it is an itchy red scaly skin disorder characterized by a very severe itch, that disrupts daily activities, and sleep and severely impairs the quality of life of patients. In the US 30 million people are affected by it, and 1/3 of these we expect to be moderate to severe.

MedicalResearch.com: What is the background for Dupilumab therapy? How does it differ from emollients, steroids or topical immunomodulator treatments for eczema ie Protopic?

Response: The background is that we currently do not have good treatments for long term use for our moderate to severe patients. The only approved drug by the FDA for atopic dermatitis in the US is oral prednisone, that has many long term side effects and causes disease rebound upon discontinuation. Other treatments with many side effects

are broad immune suppressants–Cyclopsorin A, Mycophenolate mofetyl and phototherapy that is not feasible for most patients.

Thus there is a large unmet need for safer and better treatments for moderate to severe atopic dermatitis patients.

Dupilumab is different since it only targets one immune axis–Th2 axis, providing a safer alternative, with high efficacy, that is equal or even better than cyclosporin A, that is the current gold standard immune suppressant, and harbors many side effects including permanent effects on the kidneys after long term use. Topical treatments, while useful for mild patients, are often not adequate or sufficient to control moderate to severe patients that usually have more than 10% body surface area involved and need a systemic treatment.

Continue reading

Secukinumab (Cosentyx) Provides Greater Improvement in Quality of Life, Work Productivity, and Daily Activity Than Ustekinumab (Stelara) in Moderate To Severe Psoriasis

MedicalResearch.com Interview with:
Eric Hughes, Global Head of Development, Immunology & Dermatology

Novartis Pharma AG
Basel, Switzerland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is well established that psoriasis negatively affects quality of life and work productivity. However, how the treatments affect psoriasis severity (based on skin clearance, itch, pain and scaling symptoms), health-related quality of life (HRQOL), work productivity, and daily activity directly or indirectly (via other factors) are still largely unknown.

Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis, and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile.

In CLEAR, a Phase 3b head-to-head study versus ustekinumab, secukinumab demonstrated sustained superior efficacy in clearing skin through Week 52, greater improvement in symptoms and HRQOL, greater relief of work and activity limitations, and a comparable safety profile. In this sub-analysis of the CLEAR study, Novartis was interested in examining the relationships among multiple variables that are thought to be important to patients with psoriasis. The direct and indirect (i.e. mediated) effects of treatment (secukinumab or ustekinumab) on psoriasis severity and patients’ HRQOL, work productivity, and daily activity were examined. The evaluation was conducted using structural equation modeling (or path analysis) and compared these relationships for secukinumab versus ustekinumab at 16 and 52 weeks. Structural equation modeling or path analysis is a statistical method that models the direct and indirect relationship between multiple patient-relevant outcomes simultaneously.

Goodness-of-fit statistics for all models were excellent confirming the robustness of the results. Results at Week 16 and at Week 52 for different Psoriasis Area and Severity Index (PASI) response categories (e.g. PASI 75, PASI 90, PASI 100) indicated that psoriasis treatment indirectly affected HRQOL and work productivity and daily activity, measured with the Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment (WPAI) questionnaires, respectively.

Actually, greater effect of secukinumab over ustekinumab on DLQI was mediated by greater improvement of secukinumab in PASI response as well as by greater improvement in psoriasis-related symptoms (itch, pain and scaling). Greater effect of secukinumab over ustekinumab on work productivity and daily activity was mediated by greater improvement of secukinumab in psoriasis-related symptoms.

Continue reading

Taltz Demonstrates Improved Clearing of Psoriasis Compared to Stelara

MedicalResearch.com Interview with:

Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg 07.04.2009 | Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg, Germany, 07.04.2009 | [© (c) Martin Zitzlaff, Emilienstr.78, 20259 Hamburg, Germany, Tel. +491711940261, http://www.zitzlaff.com, martin@zitzlaff.com, Postbank Hamburg BLZ 20010020 Kto.-Nr. 10204204, MwSt. 7%, Veroeffentlichung nur gegen Honorar (MFM) und Belegexemplar, mit Namensnennung]

Prof. Reich

Prof. Dr. med. Kristian Reich
Dermatologie, Allergologie
Psoriasis- und Neurodermitis-Trainer
Hamburg

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The IXORA-S study compared the efficacy and safety of Taltz® (ixekizumab) and Stelara®* (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis at 24 weeks.

In this study, patients were randomized to receive either Stelara (45 mg or 90 mg weight-based dosing per label) or Taltz (80 mg every two weeks followed by 80 mg every four weeks), following an initial starting dose of 160 mg. At 24 weeks, patients treated with Taltz achieved significantly higher response rates compared to patients treated with Stelara, including 83 percent of patients who achieved Psoriasis Area Severity Index (PASI) 90—the study’s primary endpoint—compared to 59 percent of patients who achieved PASI 90 after treatment with Stelara.

Results at 24 weeks also found:
• 91.2 percent of patients treated with Taltz achieved PASI 75 compared to 81.9 percent of patients treated with Stelara (p=0.015)
• 49.3 percent of patients treated with Taltz achieved PASI 100 compared to 23.5 percent of patients treated with Stelara (p=0.001)
• 86.6 percent of patients treated with Taltz achieve static Physician’s Global Assessment score (sPGA) 0 or 1 compared to 69.3 percent of patients treated with Stelara (p<0.001)

The majority of treatment-emergent adverse events were mild or moderate. There were no statistically significant differences between treatment groups in overall treatment-emergent adverse events. The safety profile for Taltz was consistent with previous clinical trials.

Continue reading

Ibalizumab Immunotherapy Decreased Viral Load In Resistant HIV

MedicalResearch.com Interview with:

Brinda Emu MD Assistant Professor of Medicine (Infectious Diseases Yale University New Haven, CT

Dr. Brinda Emu

Brinda Emu MD
Assistant Professor of Medicine (Infectious Diseases
Yale University
New Haven, CT 

MedicalResearch.com: What is the background for this study?

Response: Ibalizumab is a fully humanized monoclonal antibody that targets the CD4 receptor.  This Phase III registrational study enrolled individuals with HIV infection that harbor high levels of multi-drug resistance, with limited treatment options.  At IDWeek in October, 2016, data was presented that demonstrated patients experienced a significant decrease in viral load after receiving a single loading dose of ibalizumab 2,000 mg intravenously (IV) in addition to their failing antiretroviral therapies (ART) (or no therapy). Seven days after this loading dose, 83% of patients achieved a ≥ 0.5 log10 decrease from baseline compared with 3% during the seven-day control period .These results were statistically significant (p<0.0001).

At CROI, additional data on the Week 24 results from this study are now presented.

Continue reading

Allergic Rhinitis: Three Years of Immunotherapy Gives Longer Lasting Symptom Control

MedicalResearch.com Interview with:
Stephen R. Durham, MD

Imperial College, London, and Royal Brompton and Harefield Hospitals
NHS Foundation Trust
London, United Kingdom

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Allergic rhinitis affects 1 in 4 the UK population and may compromise sleep and work/school performance and be associated with bronchial asthma. When nasal steroids and antihistamines do not work or cause side effects, allergen immunotherapy is an alternative. Immunotherapy using high doses of grass pollen allergen as monthly injections or daily tablets under the tongue are highly effective. Treatment for 3 years not only gives sustained improvement on treatment but also long-term benefits and disease remission for at least 2-3 years after stopping treatment.

This single centre study at Imperial College London and Royal Brompton Hospital London included 106 adults with severe Hayfever followed up for 3 years, 2 years on treatment and 1 year after stopping treatment. In this double-blind trial, 3 randomised groups took sublingual immunotherapy, subcutaneous immunotherapy and placebo treatment. 92 completed the trial. Results showed that 2 years treatment with both modalities did not result in persistent benefit at year 3, although the researchers found that both treatments were effective compared to placebo during years 1 and 2.

Continue reading

Imatinib Revolutionizes Treatment of Unresectable/Metastatic GI Stromal Tumors

MedicalResearch.com Interview with:

Michael C. Heinrich, MD Professor of Medicine and Cell and Developmental Biology Oregon Health & Sciences University

Dr. Michael Heinrich

Michael C. Heinrich, MD
Professor of Medicine and Cell and Developmental Biology
Oregon Health & Sciences University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Prior to 2000, there were no effective medical treatments for advanced GI stromal tumor and patients faced an average life expectancy of 18 months or less.  In our study of the  long-term treatment results using imatinib (Gleevec),  we found that approximately 7% of patients were still on front-line therapy at 10 years without any evidence of tumor progression.  More importantly, the estimated 10 year survival was 23%.   Progression-free and overall survival rates were significantly higher for patients with KIT exon 11-mutant GIST when compared with patients with KIT exon 9-mutant or “wild-type” GIST (no KIT/PDGFRA mutations).

Continue reading

Vaccine Nanodiscs Can Trigger More Cancer Fighting Immune Cells

MedicalResearch.com Interview with:

James Moon, PhD John Gideon Searle Assistant Professor University of Michigan Dept. of Pharmaceutical Sciences and Biomedical Engineering Biointerfaces Institute Ann Arbor, MI, 48109

Dr. James Moon

James Moon, PhD
John Gideon Searle Assistant Professor
University of Michigan
Dept. of Pharmaceutical Sciences and Biomedical Engineering
Biointerfaces Institute
Ann Arbor, MI, 48109

MedicalResearch.com: What is the background for this study?

Response: The field of cancer immunotherapy has recently made a breakthrough with the clinical success of immune checkpoint inhibitors, which work by removing the brakes on immunosuppressed T-cells. However, these approaches generally work by augmenting pre-existing T-cell immunity and benefit only a subset of patients. In addition, because the majority of somatic mutations in cancer cells are unique to each patient, cancer immunotherapy may benefit from a personalized approach.

Continue reading

Vandetanib Had Antitumor Activity In RET-rearranged NSC Lung Cancer

MedicalResearch.com Interview with:
Dr Kiyotaka Yoh

Department of Thoracic Oncology
National Cancer Center Hospital East
Kashiwa, Japan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: LURET is multicenter, single-arm, phase II study to evaluate the efficacy and safety of vandetanib as RET inhibitor in patients with advanced RET-rearranged non-small-cell lung cancer (NSCLC). In 2012, RET rearrangements were identified as rare oncogenic alterations for NSCLC.

Among 17 eligible patients included in primary analysis, the objective response rate was 53% (95% CI 28–77), which met the primary endpoint. At the data cutoff, median progression-free survival was 4.7 months (95% CI 2.8–8.5). Overall, vandetanib was tolerated, with an adverse event profile similar to those seen in previous large population studies of vandetanib in patients with unselected NSCLC.

Continue reading

First-line ribociclib + letrozole in patients with de novo HR+, HER2- Advanced Breast Cancer

MedicalResearch.com Interview with:

Joyce O'Shaughnessy, MD Co-Chair, Breast Cancer Research Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dr. Joyce O’Shaughnessy

Joyce O’Shaughnessy, MD
Co-Chair, Breast Cancer Research
Texas Oncology-Baylor Charles A. Sammons Cancer Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The MONALEESA-2 trial is a Phase III, randomized, double-blind, international study of LEE011 in combination with letrozole vs. letrozole alone, in postmenopausal women with HR+/HER2- advanced breast cancer who had received no prior systemic therapy for advanced disease.

Because de novo disease has not been previously treated with systemic treatment for early-stage breast cancer, tumors may exhibit a different disease biology, which could result in varied responses compared to patients who experience recurrence of their initial breast cancer. We analyzed a pre-defined subgroup of women with de novo HR+/HER2- advanced breast cancer to better understand the response of LEE011 plus letrozole in this patient population.

In the de novo advanced breast cancer patient sub-group, progression free survival was significantly prolonged; LEE011 plus letrozole reduced the risk of disease progression or death by 55% over letrozole alone (HR=0.448 [95% CI: 0.267–0.750]). The 12-month PFS rate was 82% in the LEE011 plus letrozole arm compared to 66% with letrozole alone.

Most adverse events were mild to moderate in severity, identified early through routine monitoring, and generally managed through dose interruption and reduction. The most common all-grade adverse events (≥30% of patients with de novo advanced breast cancer) in the LEE011 plus letrozole arm were neutropenia (70.2%), nausea (48.2%), fatigue (42.1%), alopecia (39.5%), and leukopenia (31.6%).

Continue reading

Mesothelioma: Nintedanib Plus Chemotherapy Demonstrated Improved Progression-Free Survival

Professor Giorgio V. Scagliotti Chair of the Department of Oncology University of Torino,Italy

Prof. Scagliotti

MedicalResearch.com Interview with:
Professor Giorgio V. Scagliotti

Chair of the Department of Oncology
University of Torino,Italy


MedicalResearch.com: What is the background for this study? What are the main findings?

Response: LUME-Meso II is an international study designed to evaluate the safety and efficacy of nintedanib plus pemetrexed/cisplatin, followed by nintedanib versus placebo plus pemetrexed/cisplatin, followed by placebo, for the treatment of patients with unresectable malignant pleural mesothelioma (MPM).

MPM is a rare cancer that affects the cells that make up the mesothelium of the pleura – the lining or membrane that covers and protects the lungs. It represents less than 1% of all cancers and is often related to long-term asbestos exposure.

A significant improvement in progression-free survival (PFS), the study’s primary endpoint, was observed for patients receiving nintedanib plus chemotherapy compared to patients receiving placebo plus chemotherapy.

Continue reading

Breast Cancer: PARP Inhibitor Veliparib Has Potential To Enhance Platinum Chemotherapy in Recurrent or Metastatic Disease

MedicalResearch.com Interview with:
Vince Giranda, M.D., PH.D.
Project Director
AbbVie Oncology Development

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In this Phase 2 study, called BROCADE 2, veliparib combined with the platinum chemotherapy regimen carboplatin and paclitaxel showed positive trends in overall survival (OS) and progression-free survival (PFS), although these were not statistically significant. Importantly there were no meaningful increase in side effects with the addition of veliparib to carboplatin and paclitaxel. The veliparib combination regimen also demonstrated a significantly higher objective response rate.

Continue reading

No Increased Risk of IBD Among Secukinumab-Treated Patients with Moderate to Severe Psoriasis in Phase 2 & 3 Clinical Studies

MedicalResearch.com Interview with:

Atul Deodhar, M.D., M.R.C.P. Rheumatology Oregon Health and Science University

Dr. Atul Deodhar

Atul Deodhar, M.D., M.R.C.P.
Rheumatology
Oregon Health and Science University 

MedicalResearch.com: What is the background for this study?

Response: Patients with psoriasis, psoriatic arthritis (PsA), or ankylosing spondylitis (AS) are at an increased risk of developing inflammatory bowel disease (IBD) compared with the general population. It is important that we assess whether new therapies, including the recently approved interleukin-17A (IL-17A) inhibitor, secukinumab, have an acceptable profile in terms of the risk of IBD in patients with psoriasis, PsA, or AS.

Continue reading

Multiple Sclerosis: Interim Report on the Safety and Efficacy of Long-Term Daclizumab Treatment for Up to Five Years

MedicalResearch.com Interview with
Ralph Kern, M.D.
Senior vice president, Worldwide Medical
Biogen

MedicalResearch.com: What is the background for this study?

Response: Previously reported clinical trials of daclizumab demonstrated significant efficacy across clinical and MRI measures, compared to placebo and interferon beta-1a 30 mcg intramuscular (IM) injection, and established the therapy’s safety profile for up to two to three years. These trials were the basis for approval by health authorities in the United States, European Union and Australia. Daclizumab is a once-monthly, self-administered, subcutaneous therapy for relapsing forms of MS (RMS).

At ECTRIMS we presented the first interim results from EXTEND, a long-term extension study. EXTEND is an ongoing multicenter, open-label study to evaluate the safety and efficacy of daclizumab treatment in more than 1,500 patients with RMS.

This interim ECTRIMS analysis includes up to five years of data from patients who were previously enrolled in DECIDE. DECIDE was a Phase 3 study evaluating the effects of daclizumab relative to interferon beta-1a IM. In the new analysis, patients who were treated with interferon beta-1a IM for two to three years in DECIDE switched to daclizumab when they enrolled in EXTEND, and were compared to daclizumab patients treated continuously in both DECIDE and EXTEND.

Continue reading

Activation of the STING Pathway Induces Tumor Immunity

MEDICALRESEARCH.COM INTERVIEW WITH:

THOMAS W. DUBENSKY, JR., PH.D.</strong> CHIEF SCIENTIFIC OFFICER ADURO BIOTECH, INC.

DR. THOMAS W. DUBENSKY, Jr.

THOMAS W. DUBENSKY, JR., PH.D.
CHIEF SCIENTIFIC OFFICER
ADURO BIOTECH, INC.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This presentation highlights findings from multiple preclinical models evaluating ADU-S100 (also known as MIW815), Aduro Biotech’s investigational STING (Stimulator of Interferon Genes) Pathway Activator immunotherapy. The company is developing ADU-S100 in partnership with Novartis.

ADU-S100 is a synthetic ‘off-the-shelf’ small molecule immune modulator that is designed to generate a response against a patient’s own unique set of cancer antigens. It does this through the activation of human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T-cell adaptive immune response.

We conducted preclinical studies in a variety of preclinical models to better understand the potential mechanism of action of ADU-S100 and its potential for treating a variety of cancer types, both within the immediate tumor environment, as well as throughout the body. Data from these preclinical studies suggest the following:

  • Intratumoral injection of ADU-S100 activates the STING Pathway and induces both a durable local and systemic anti-tumor immune response as evidenced by induction of type I interferons (IFNs) and a CD8+ T-cell response.
  • ADU-S100 is able to induce tumor-specific memory mediated by immune cells (e.g. T-cells and NK-cells) whereby the immune system is able to eliminate specific cancerous cells upon their reintroduction without further therapy.
  • Combination of STING activation in the tumor microenvironment and an anti-PD-1 checkpoint inhibitor enhances antitumor efficacy activation of the STING pathway, resulting in the complete eradication of local and distal tumors.

Continue reading

Juvenile Arthritis: TNF Inhibitor Use Doesn’t Appear To Increase Malignancy Risk

MedicalResearch.com Interview with:

Timothy Beukelman, MD, MSCE Associate Professor of Pediatrics Division of Rheumatology and Division of Clinical Immunology & Rheumatology University of Alabama at Birmingham

Dr. Timothy Beukelman

Timothy Beukelman, MD, MSCE
Associate Professor of Pediatrics
Division of Rheumatology and
Division of Clinical Immunology & Rheumatology
University of Alabama at Birmingham

MedicalResearch.com: What is the background for this study?

Response: In 2009 the US FDA issued a boxed warning about malignancies reported in children treated with TNF inhibitors but their analysis did not account for a possible malignancy risk from other medications of from the Juvenile idiopathic arthritis (JIA) disease process itself.

Continue reading

PD-1 Blockers Improve Survival in Melanoma, With Lowest Risk of Side Effects

MedicalResearch.com Interview with:

Feng Xie, Ph.D.</strong> Associate Professor Department of Clinical Epidemiology and Biostatistics Faculty of Health Sciences, McMaster University

Dr. Feng Xie

Feng Xie, Ph.D.
Associate Professor
Department of Clinical Epidemiology and Biostatistics
Faculty of Health Sciences
McMaster University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Cutaneous melanoma, an aggressive and deadly form of skin cancer, in early stages is often cured with surgery alone. Most patients presenting with advanced-stage disease, however, are not candidates for surgery and drug therapy is the main course of treatment. Around 40-60% of melanomas have a mutation in the BRAF protein. Multiple effective first-line treatment options are available for patients with advanced BRAF-mutated melanoma, which fall under two established classes of drug therapies: targeted therapy and immunotherapy. Presently, it remains uncertain which is the optimal first-line treatment.

In our network meta-analysis we evaluated 15 randomized controlled trials published between 2011 and 2015 assessing the benefits and harms of targeted or immune checkpoint inhibitors in 6662 treatment naïve patients with lymph node metastasis not amenable to surgery or distant metastatic melanoma.

We found that combined BRAF and MEK targeted therapy and PD-1 immunotherapy were both equally effective in improving overall survival. Combined BRAF and MEK inhibition was most effective in improving progression-free survival. PD-1 inhibition was associated with the lowest risk of serious adverse events.

Continue reading

Successful Expansion and Characterization of Tumor Infiltrating Lymphocytes from Non-melanoma Tumors

MedicalResearch.com Interview with:

Dr. Michael Lotze, MD Chief Scientific Officer, Lion Biotechnologies San Carlos, CA 94070

Dr. Lotze

Dr. Michael Lotze, MD
Chief Scientific Officer, Lion Biotechnologies
San Carlos, CA 94070

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Adoptive cell therapy (ACT) with Tumor-infiltrating Lymphocytes (TIL) has shown promise in mediating cancer regression which rely on activation in vivo compared to other immunotherapies that utilize genetically modified T-cells. In TIL therapy, autologous administration of TIL expanded outside the body elicits a highly individualized, specific and potent attack against the tumor. Clinical trials conducted at the National Cancer Institute evaluating TIL therapy for the treatment of metastatic melanoma reported overall response rates of up to 56%. The durable responses observed in these metastatic melanoma patients as well as other patients with cervical cancer, cholangiocarcinoma, and head and neck cancer signal the potential for broader application of TIL therapy to treat patients with other solid tumors, currently an area of substantial unmet clinical need. Lion’s study, recently presented at the Society for Immunotherapy of Cancer, sought to demonstrate the feasibility of culturing and expanding TIL isolated from non-melanoma tumors. We were successful in culturing TIL from tumors obtained from bladder, cervical, head and neck, lung and triple negative breast cancer.

Continue reading

Imugene Building Pipeline of B Cell Peptide Cancer Vaccines

MedicalResearch.com Interview with:

Leslie Chong Imugene Chief Operating Officer Armadale, Australia

Leslie Chong
Imugene
Chief Operating Officer
Armadale, Australia

 

MedicalResearch.com: What is the background for this study? How does HER-Vaxx work?

• The technology originates from the Medical University of Vienna, one of Europe’s leading cancer institutes and was identified in 2012 by Dr Axel Hoos (Currently Sr. Vice President of Oncology R&D at GlaxoSmithKline, previous Clinical Lead on Ipilumimab at Bristol-Myers Squibb, a director at Imugene; his only Board seat worldwide)
• HER-Vaxx is a peptide vaccine designed to treat tumours that over-express the HER2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The vaccine is constructed from various B Cell epitopes of HER2/neu. It has been shown in pre-clinical work and in a Phase 1 study to stimulate a potent polyclonal antibody response to HER2/neu, a commercially and clinically validated cancer target. HER-Vaxx’s successful Phase 1 study was in patients with metastatic breast cancer and the next stage of development will be a Phase 1b/2 study in patients with gastric cancer initiating in 2016.

Continue reading

Overall survival data from LUX-Lung 7 head-to-head trial of Afatinib versus Gefitinib

MedicalResearch.com Interview with:

Shirish Gadgeel, MD Leader of the Thoracic Oncology Multidisciplinary team Professor at Karmanos Cancer Institute Detroit

Dr. Shirish Gadgeel

Shirish Gadgeel, MD
Leader of the Thoracic Oncology Multidisciplinary team
Professor at Karmanos Cancer Institute
Detroit

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positiveNon-Small Cell Lung Cancer NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harboring common EGFR mutations (del19 or L858R). The trial’s co-primary endpoints were progression-free survival (PFS) by independent review, time to treatment failure and overall survival (OS); and the secondary endpoints included ORR, disease control rate, tumor shrinkage, patient-reported outcomes and safety.

Continue reading

Combination Everolimus/Exemestane For ER+|HER2- Advanced Breast Cancer

MedicalResearch.com Interview with:

Melanie Royce, MD, PhD Professor of Medicine University of New Mexico School of Medicine Director of the Breast Multidisciplinary Clinic and Program UNM Cancer Center. Albuquerque, NM

Dr. Melanie Royce

Melanie Royce, MD, PhD
Professor of Medicine
University of New Mexico School of Medicine
Director of the Breast Multidisciplinary Clinic and Program
UNM Cancer Center.
Albuquerque, NM

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: BOLERO-4 is an open label, single-arm, Phase II study that evaluates the combination of everolimus plus letrozole as a first-line treatment for hormone receptor (HR)-positive/HER2-negative advanced breast cancer patients, as well as the use of everolimus plus exemestane beyond initial progression.

Results of the Phase II BOLERO-4 clinical trial, presented as an oral presentation at the 2016 European Society for Medical Oncology (ESMO) annual meeting, show preliminary evidence that everolimus in combination with letrozole is effective in treating women with HR-positive/HER2-negative advanced breast cancer in the first-line setting. With follow up of 17.5 months, the median progression-free survival (PFS) is not yet reached. At six months, 83.6% (95% CI: 77.3-88.2%) of women taking everolimus plus letrozole in the first-line setting were without disease progression, and 71.4% (95% CI: 64.0%-77.5%) did not have disease progression at twelve months.

Safety findings from BOLERO-4 are consistent with previous studies of everolimus in advanced breast cancer, with the most common adverse events being stomatitis (67.8%), weight loss (42.6%) and diarrhea (36.1%). These adverse events were mostly grade 1 or 2 in severity1.

Continue reading

PD-1 Blockers Offer Hope To Some Patients With Metastatic Urothelial Cancer

MedicalResearch.com Interview with:

Arjun Balar, M.D. Assistant Professor of Medicine Director - Genitourinary Medical Oncology Program NYU Perlmutter Cancer Center New York, NY 10016

Dr. Arjun Balar

Arjun Balar, M.D.
Assistant Professor of Medicine
Director – Genitourinary Medical Oncology Program
NYU Perlmutter Cancer Center
New York, NY 10016

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Standard treatment for advanced urothelial cancer includes cisplatin-based chemotherapy which has been shown to improve survival. But more than half of patients are not expected tolerate it well and alternative treatment is inferior to cisplatin. The average survival for these patients is in the range of 9-10 months with carboplatin-based treatment, which is the most commonly used alternative to cisplatin. Pembrolizumab is a PD-1 blocking antibody that reactivates the body’s cancer-fighting T-cells (part of the immune system) to fight urothelial cancer.

The trial overall enrolled 374 patients who had not yet received any treatment for advanced urothelial cancer, but were considered ineligible for cisplatin chemotherapy.

Continue reading

Niraparib Increased Progression Free Survival in 2/3 Ovarian Cancer Patients

MedicalResearch.com Interview with:

Mansoor Raza Mirza, MD Medical Director: Nordic Society of Gynecologic Oncology (NSGO) Board of Directors: Gynecologic Cancer Inter-Group (GCIG) Faculty: European Society of Medical Oncology (ESMO) Faculty: International Gynecologic Cancer Society (IGCS) Chief Oncologist, Rigshospitalet Copenhagen University Hospital Copenhagen, Denmark

Dr. Mansoor Raza Mirza

Dr. Mansoor Raza Mirza, MD
Medical Director: Nordic Society of Gynecologic Oncology
Board of Directors: Gynecologic Cancer Inter-Group (GCIG)
Faculty: European Society of Medical Oncology (ESMO)
Faculty: International Gynecologic Cancer Society (IGCS)
Chief Oncologist, Rigshospitalet
Copenhagen University Hospital
Copenhagen, Denmark

MedicalResearch.com: What is the background for this study?

Response: Recurrent ovarian cancer is an area of significant unmet medical need, and there have been few therapeutic advances for these patients in the past few decades.

Niraparib was studied to provide patients with recurrent ovarian cancer an option other than “watchful waiting,” potentially redefining the standard of care for the disease. The ENGOT-OV16/NOVA trial was a Phase 3 double-blind, randomized, placebo-controlled international study of maintenance treatment with niraparib compared with placebo. Niraparib successfully achieved the primary endpoint of prolonging progression-free survival versus placebo in all three prospectively defined primary efficacy populations:
Continue reading

Novel Immune Checkpoint Inhibitor Has Potential Against Variety of Tumors

MedicalResearch.com Interview with:

Bernard Vanhove, Chief Operating Officer Director of R&D and International Scientific Collaborations Ose Immunotherapeutics

Bernard Vanhove

Bernard Vanhove, Chief Operating Officer
Director of R&D and International Scientific Collaborations
Ose Immunotherapeutics

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Myeloid suppressive cells, including tumor associated macrophages (TAM) and myeloid-derived suppressor cells (MDSC), represent an abundant immune cell type in the microenvironment of solid tumors where they promote tumor growth, metastases, angiogenesis, inhibiting anti-tumor immune responses. Myeloid cells selectively express SIRPα, an immune tyrosine associated inhibitory receptor (also named CD172a), which controls myeloid functions.

We investigated the role of Effi-DEM, new generation checkpoint inhibitor specifically targeting the SIRP- α receptor on the strategic SIRP-α/CD47 pathway in human macrophages polarization and MDSC differentiation. CD47 the ligand of SIRP alpha is ubiquitously expressed in human cells and has been found to be overexpressed in many different tumor cells with a poor prognosis established. Effi-DEM is a selective antagonist of these myeloid suppressive cells as its target SIRP-α is expressed on these cells. Based on this rationale, the preclinical studies conducted with Effi-DEM have demonstrated its potential to transform suppressor myeloid and tumor associated macrophage cells in non-suppressive cells, thereby inducing a reactivation of the immune response. Effi-DEM has also shown to be effective in various aggressive cancer models with encouraging preclinical results, both in monotherapy and in therapeutic combinations with anti-PD-L1 (checkpoint inhibitors) and anti-CD137 (4-1BB) mAbs, activators of the T-cell response. Significant efficacy and survival increase data were demonstrated in models of hepatocarcinoma, melanoma and triple negative breast cancer.

Continue reading

Tildrakizumab Offers Potential New Psoriasis Treatment With Quarterly Dosing

MedicalResearch.com Interview with:
Dr. Kristian Reich
Professor of Dermatology at the Georg-August-University Göttingen and inflammation specialist Dermatologikum Hamburg in Germany

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: While there is ongoing research into the causes and triggers of psoriasis, recent studies have identified IL-23 as a main driver of the IL-23/IL-17 pathway which is now thought to be the predominant pathway in the psoriasis inflammatory cascade. Selective Inhibition of IL-23 may present a new targeted strategy for treating patients with the condition. The hope for molecules selectively targeting IL-23, specifically the p19 component of the cytokine, is that newer therapies, like tildrakizumab, can more selectively control the disease allowing more patients to achieve higher and even more durable clinical responses.

The two pivotal Phase-3 studies (reSURFACE 1 and 2) evaluated the efficacy and safety of the IL-23 inhibitor tildrakizumab in adult patients with moderate-to-severe plaque psoriasis, and results through week 28 were presented for the first time as part of the Late Breaking News Session at EADV.

In the reSURFACE 1 and 2 pivotal Phase-3 studies, tildrakizumab, a selective IL-23p19 inhibitor, was evaluated against placebo and etanercept to assess efficacy, safety and tolerability. The co-primary efficacy endpoint of the two placebo-controlled studies was a) the proportion of patients with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician’s Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The reSURFACE 2 also included an etanercept comparator arm, with a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Other co-secondary endpoints of both placebo controlled studies included PASI 90 and PASI 100 responses at week 12 and PASI 75, 90 and 100 and PGA responses from baseline at Week 28.

Continue reading

Ribociclib and Letrozole May Represent Paradigm Shift in Treating HR+ Advanced Breast Cancer

MedicalResearch.com Interview with:

Gabriel N. Hortobagyi, MD, FACP, F.A.S.C.O. Professor of Medicine Nellie B. Connally Chair in Breast Cancer Department of Breast Oncology Co-Director, Multidisciplinary Breast Cancer Research Program University of Texas MD Anderson Cancer Center Houston, Texas

Prof. Gabriel N. Hortobagyi

Gabriel N. Hortobagyi, MD, FACP, F.A.S.C.O.
Professor of Medicine
Nellie B. Connally Chair in Breast Cancer
Department of Breast Oncology
Co-Director, Multidisciplinary Breast Cancer Research Program
University of Texas MD Anderson Cancer Center
Houston, Texas

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: MONALEESA-2 is a Phase III randomized, double blind, placebo controlled, multicenter global registration trial to evaluate the safety and efficacy of LEE011 in combination with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who received no prior therapy for their advanced breast cancer.

The primary efficacy results from the pivotal MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS) compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (HR= 0.556; 95% CI: 0.429-0.720; p=0.00000329)1.

The results demonstrate that LEE011 plus letrozole reduced the risk of death or progression by 44% over letrozole alone, significantly extending PFS across all patient subgroups. More than half of women with measurable disease taking LEE011 plus letrozole saw their tumor size shrink by at least 30% during treatment (overall response rate (ORR) in patients with measurable disease = 53% vs 37%, p=0.00028)1.

Continue reading

Experimental Antibody Reduced Amyloid Plaques in Alzheimer’s

MedicalResearch.com Interview with:

Roger M. Nitsch, MD Professor and Director Institute for Regenerative Medicine · IREM University of Zurich Campus Schlieren Switzerland

Prof. Roger Nitsch

Roger M. Nitsch, MD
Professor and Director
Institute for Regenerative Medicine · IREM
University of Zurich Campus Schlieren
Switzerland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The main finding is that treatment with aducanumab resulted in an unprecedented reduction of brain amyloid plaques in patients with Alzheimer’s disease.  The removal of amyloid from patients brains were both dose- and time-dependent.  We also observed initial hints for stabilized brain functions in patients receiving aducanumab.  In contrast, patients in the placebo group continued to declined as usual in this stage of Alzheimer’s disease.

The main safety finding in 22% of all treated patients was ARIA – an Amyloid-Related Imaging Abnormality – suggestive of fluid shifts in the brains. In most cases, ARIA occurred in the absence of clinical signs and resolved spontaneously.  In one third of the ARIA cases, patients experienced transient headaches.  None of the patients had to hospitalized because of ARIA.

Continue reading

Gene Therapy Delivers Intracellular Antibodies To Attack Abnormal Protein in Huntington’s Disease

MedicalResearch.com Interview with:
Lee Henderson, Ph.D. CEO Vybion, Inc. Ithaca, NY 14852Lee Henderson, Ph.D.
CEO, Vybion, Inc.
Ithaca, NY 14852

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Huntington’s disease (HD) is a progressive and fatal neurodegenerative disease characterized by loss of both cognitive and motor function as a result of neuron loss primarily within the brain striatum. HD is directly caused by the expansion of CAG repeats in the huntingtin gene resulting in an expanded glutamine region (polyQ) near the N-terminus of the protein. Age of disease onset and the rate of progression is directly correlated to the size of the expansion with pathology observable at 35-70 repeats in adults and greater in juvenile onset. During normal turnover and degradation of the huntingtin protein, the N-terminal polyQ-containing fragments drive pathology and aggregate formation in cells. The direct link to progression has been described by several laboratories using cell-based and animal model studies and confirmed in humans as the binding of these N-terminal fragments to DNA and transcription factors that result in widespread gene dysregulation in neurons.

Continue reading

Immodulon Aims to Activate Both Arms of Immune System To Fight Broad Range of Cancers

MedicalResearch.com Interview with:
Dr Charles Akle, Chairman and Linda Summerton, CEO Immodulon Therapeutics Short Hills, NJ 07078 and London, UKDr Charles Akle,
 Chairman and
Dr. Linda Summerton, CEO
Immodulon Therapeutics
Short Hills, NJ 07078 and
London, UK

MedicalResearch.com: What is the background for Immodulon? Would you tell us a little about Dr. Charles Akle?

Response: Immodulon was established in November 2007. The founder and Chairman, Dr Charles Akle, was a Harley Street surgeon and pioneer of keyhole surgery who established Immodulon with the financial support of a former patient. His interest in immunology led him to the potential of cancer immunotherapy long before the term “immuno-oncology” was coined and when skepticism, rather than optimism was the norm.

His ambition from the start was to develop an affordable immunotherapy treatment that would transform the way that cancer is treated in the world today. Since then, Immodulon has become a leading, independent biopharmaceutical company with one of the longest running research projects into how to harness the power of the immune system in treating cancer. It also has its own R&D and manufacturing capability in Lyon, France.

The wider Immodulon senior team has extensive experience of bringing drugs to market and includes Dr James Shannon and Dr Jean Pierre Bizzari.

Continue reading

Incidence of Pneumonitis from PD-1 Blockers Across Cancers Identified

MedicalResearch.com Interview with:

Mizuki Nishino, MD MPH  Department of Radiology Brigham and Women’s Hospital and  Dana-Farber Cancer Institute Boston, Massachusetts

Dr. Mizuki Nishino

Mizuki Nishino, MD MPH
Department of Radiology
Brigham and Women’s Hospital and
Dana-Farber Cancer Institute
Boston, Massachusetts

MedicalResearch.com: What is the background for this study?

Response: Immune-checkpoint inhibitors including PD-1 and PD-L1 inhibitors have brought remarkable advances in treatment of cancer patients. Immune-checkpoint inhibitors are associated with a unique set of adverse events, termed immune-related adverse events (irAEs).

Among various irAEs, PD-1 inhibitor-related pneumonitis is a relatively uncommon yet clinically significant and potentially lethal event, and has been recognized as an “event of special interest”. We have previously reported the clinical and radiographic characteristics of PD-1 inhibitor-related pneumonitis in advanced melanoma patients and non-small-cell lung cancer patients. In spite of the increasing clinical needs to further understand the entity in terms of risk factors and incidence among different patient cohort, there has been no report of the incidence of PD-1 inhibitor-related pneumonitis across different tumor types and different therapeutic regimen.

These backgrounds motivated us to perform a meta-analysis of the incidence of pneumonitis in published trials of PD-1 inhibitors, in order to further advance knowledge of this emerging entity and identify the needs for future studies.

MedicalResearch.com: What are the main findings?

Response: In the present meta-analysis of 20 published clinical trials of melanoma, non-small-cell lung cancer (NSCLC) and renal cell carcinoma (RCC) demonstrated that the incidence of PD-1 inhibitor-related pneumonitis is significantly higher in NSCLC and renal cell carcinoma compared to melanoma, and during combination therapy compared to monotherapy.

We believe that these findings contribute to enhance awareness of this entity among clinical providers and provide a basis for further investigations to meet the urgent clinical needs.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

 

 

 

Lymphoma Drug Shows Promising Results in Phase 3 Trial

MedicalResearch.com Interview with:

Dirk Huebner, MD Senior Medical Director Oncology Therapeutic Area Unit Takeda Pharmaceutical Company

Dr. Dirk Huebner

Dirk Huebner, MD
Senior Medical Director
Oncology Therapeutic Area Unit
Takeda Pharmaceutical Company

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. Cutaneous T-cell lymphoma, also known as CTCL, is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis.

ADCETRIS® (brentuximab vedotin) is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL. The Phase 3 ALCANZA trial compared the use of single-agent ADCETRIS to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy.

The study met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4). The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm.

Continue reading

Phase 3 Trial of Iomab-B as an Induction and Conditioning Agent Prior to Bone Marrow or Stem Cell Transplant in Relapsed or Refractory AML

MedicalResearch.com Interview with:

Felix Garzon, MD, PhD Senior Vice President Head of Clinical Development Actinium Pharmaceuticals, Inc. New York, NY 10016

Felix Garzon

Felix Garzon, MD, PhD
Senior Vice President
Head of Clinical Development
Actinium Pharmaceuticals, Inc.
New York, NY 10016

MedicalResearch.com: What is the background for this study? What is goal of this Study?

Response: Iomab-B (“Iomab”) was developed at the Fred Hutchinson Cancer Research Center (“the Hutch”) in Seattle, Washington. The Hutch is a pioneer in the field of bone marrow transplantation (BMT) having 3 Nobel Prizes and doctors there performed some of the first transplants for leukemia patients. Iomab-B is intended to be an induction and conditioning agent prior to a BMT for patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55. BMT is the only potentially curative option for AML i.e. for this patient population that currently has a survival prognosis of 2-6 months which means that if Iomab-B is successful it would create a new market segment and offer patients a great clinical benefit and a hope for a cure. Actinium Pharmaceuticals licensed Iomab from the Hutch in 2012 and prior to us licensing Iomab, it had been studied in almost 300 patients in several phase 1 and phase 2 clinical trials in an array of blood cancers, both leukemias and lymphomas. Actinium is now the sponsor of a pivotal phase 3 trial for Iomab-B to study its use as an induction and conditioning agent prior to a bone marrow transplantation in patients with relapsed or refractory AML who are over the age of 55. This trial, which we have named the SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial, started at the end of June 2016 and we expect to enroll 150 patients by the end of 2017.

The primary endpoint of the SIERRA trial is durable complete remissions (dCR) of 6 months. The study arm will consist of Iomab-B administration followed by a  bone marrow transplantation, patients will be evaluated for dCR at 6 months after engraftment, which will be assessed at day 28 or day 56. The control arm of the study will be physician’s choice of chemotherapy and if the patient is able to achieve a complete remission (CR) they may receive a BMT or some other form of treatment with curative intent. The study is designed to evaluate if the study arm of Iomab-B and a BMT can double the dCR rate of the control arm, which is designed to replicate the current treatment regimen prior to a bone marrow transplantation .

Continue reading

Nintedanib – Ofev – Slows Progression in Broader Group of Idiopathic Pulmonary Fibrosis Patients

MedicalResearch.com Interview with:

Ganesh Raghu, M.D. FACP, FCCP Professor of Medicine Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases Director, Interstitial Lung Disease/Sarcoid/Pulmonary Fibrosis Program University of Washington Medical Center Seattle, Washington

Dr. Ganesh Raghu

Ganesh Raghu, M.D. FACP, FCCP
Professor of Medicine
Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases
Director, Interstitial Lung Disease/Sarcoid/Pulmonary Fibrosis Program
University of Washington Medical Center
Seattle, Washington

MedicalResearch.com: What is the background for this study?

Response: This is a new post-hoc analysis of the Phase III INPULSIS trials, including a total of 1,061 patients with idiopathic pulmonary fibrosis (IPF), which has been published in the American Journal of Respiratory and Critical Care Medicine.

As background, achieving an accurate diagnosis of IPF in clinical practice is very complex and challenging. Physicians use an imaging technique called high resolution computed tomography (HRCT) to help them identify the presence of scarring (fibrosis) and, specifically, the presence of usual interstitial pneumonia (UIP) pattern in the lungs. The radiological changes called “honeycombing” are the key feature of the UIP pattern visible on HRCT and the pattern of UIP is the hallmark of the fibrosis in patients with IPF. In the absence of definitive UIP pattern on HRCT images of the lungs, the diagnosis of  idiopathic pulmonary fibrosis requires the microscopic features of UIP in the surgical lung biopsy (SLB) based on current guidelines for diagnosis of IPF.

However, it can be challenging to confirm that scarring in the absence of honeycombing on HRCT meets the strict guideline criteria for a definitive diagnosis of IPF. For a large group of patients who do not receive a confirmed diagnosis of IPF according to guidelines, including those not eligible for surgical lung biopsy, the clinical course of their condition and the effectiveness of  idiopathic pulmonary fibrosis treatment remains unknown. Therefore, investigations into the behavior of the disease across diagnostic subgroups are important.

Continue reading

PD-1 Blocker May Help Some With Metastatic Prostate Cancer

MedicalResearch.com Interview with:

Julie Graff, M.D. Oncologist specializing in prostate cancer Knight Cancer Institute Oregon Health & Science University

Dr. Julie Graff

Julie Graff, M.D.
Oncologist specializing in prostate cancer
Knight Cancer Institute
Oregon Health & Science University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Men with metastatic prostate cancer that is not responding to second-line androgen receptor blockade (such as enzalutamide) have a very limited life expectancy. We found that adding immunotherapy to enzalutamide in men whose prostate cancer is no longer responding to enzalutamide could exert a very strong anti-cancer effect. Previous experience with this type of immunotherapy in prostate cancer patients suggested this type immunotherapy does not work in patients with prostate cancer. What we have found will lead to more studies of this agent.

Continue reading