COLVERA™ Blood Test Provides Improved Effectiveness Detecting Recurrence of Colorectal Cancer

MedicalResearch.com Interview with:

Lawrence LaPointe, Ph.D. Chief Innovation Officer Clinical Genomics Bridgewater, New Jersey 

Dr. LaPointe

Lawrence LaPointe, Ph.D.
Chief Innovation Officer
Clinical Genomics
Bridgewater, New Jersey 

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

Response: Colorectal cancer is a cancer of the colon and the rectum. The American Cancer Society estimates that about 1 in 21 men and 1 in 23 women in the United States will develop colorectal cancer during their lifetime.

This disease is the second leading cause of cancer death in women, and the third for men. Colorectal cancer has a high 5-year recurrence rate and most likely is spread to the liver and lungs.

Clinical Genomics has two decades of experience striving to save lives and reduce costs by developing easy-to-use tests for the detection of colorectal cancer. With breakthrough diagnostic tools, the company aims to offer affordable and accurate tests, supporting physicians and patients with potential life-saving knowledge about colorectal cancer.

On June 3, 2019, Clinical Genomics presented research detailing breakthrough methods of colorectal cancer recurrence monitoring at the American Society of Clinical Oncology (ASCO) annual meeting in the McCormick Place Convention Center, Chicago. 

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Medicaid Expansion Reduced Racial Disparities in Cancer Treatment

MedicalResearch.com Interview with:

Blythe J.S. Adamson, PhD, MPH Senior Quantitative Scientist Flatiron Health

Dr. Adamson

Blythe J.S. Adamson, PhD, MPH
Senior Quantitative Scientist
Flatiron Health

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

Response: Racial disparities in access and outcomes have been documented across the full trajectory of cancer-related care. This includes access to prevention and screening, to early diagnosis, treatment, survival and other health outcomes. While these disparities have been well documented, finding mechanisms to reduce disparities is more challenging. One potential mechanism to reduce treatment disparities is to improve access to insurance coverage. The Affordable Care Act (ACA), passed in March 2010, included as its overall goals the improvement in healthcare quality and access, and enhancing equity in treatment and outcomes. The ACA allowed states to expand Medicaid to poor and near-poor adults, and this was implemented by many states starting in 2014. In addition, the ACA established private insurance marketplaces with income-based premium subsidies and limits on out-of-pocket spending for qualifying low-income enrollees.

Prior research has demonstrated that ACA Medicaid expansions are associated with increased coverage and improved overall access for cancer survivors; and for newly diagnosed patients, the ACA was associated with increased coverage and shifts to earlier stage diagnosis for some cancers. To our knowledge, no research has yet demonstrated that the ACA coverage expansions affected the process of cancer care, specific cancer treatments received or specific treatment outcomes, let alone whether disparities were reduced.  In this study we looked at the time from advanced/metastatic diagnosis to start of systemic treatment for black vs. white patients and based on whether they were diagnosed at a time and in a state that had vs. had not implemented Medicaid expansion. Our study hypothesis was that Medicaid expansion reduced disparity in timely treatment of black patients compared to white patients with advanced cancer. We defined timely treatment as start of systemic therapy within 30 days of advanced/metastatic diagnosis.

This is a retrospective observational study, not a randomized controlled trial. In other words, we selected a cohort of patients diagnosed with advanced or metastatic cancers over time and observed whether they received timely treatment. The Flatiron Health EHR-derived database was the principal data source for this research. Flatiron contributing practices include 280 cancer community based clinics and academic hospital outpatient settings (~800 sites of care) representing more than 2.2 million patients with cancer in the United States. Practices are located in 40 states. To produce the database, Flatiron extracted data from structured fields, including demographics, and recorded medication orders and administrations. Flatiron also abstracted unstructured data, using technology assisted review by highly trained clinicians. Abstracted data include diagnosis date, stage, and prescribed oral anticancer medications. The database used for research purposes was de-identified. We also used data from the Kaiser Family Foundation which has tracked Medicaid implementation policies for over twenty years, and the US Bureau of Labor Statistics from which we pulled state-year unemployment rates.

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Children with High Risk AML: Intensification of Induction II Chemotherapy and Liberalization of Stem Cell Donor Source does not Improve Outcomes

MedicalResearch.com Interview with:
Joseph Germino, M.D., PhD
Vice President US Medical Affairs Oncology
Bayer Healthcare Pharmaceuticals
Whippany, N.J. 07981

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

Response: Sorafenib (Nexavar®) is an oral anticancer therapy approved in more than 100 countries worldwide. It is approved for the treatment of patients with advanced hepatocellular carcinoma (HCC); advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; progressive, locally advanced or metastatic differentiated thyroid carcinoma (papillary/follicular/Hürthle cell), that is refractory to radioactive iodine (RAI).

The AAML 1031 is a recently completed Phase III clinical trial evaluating the use of bortezomib and sorafenib in patients 30 years or younger with newly diagnosed acute myeloid leukemia (AML).

At the 2019 ASCO Annual meeting, results of a report from the AAML1031 trial, which assessed whether intensification of Induction II chemotherapy (ADE or AraC/ Mitoxantrone) and liberalized stem cell transplant (SCT) donor source criteria improved clinical outcomes in patients with residual AML.  Continue reading

Despite Large Numbers of Female Gynecologic Surgeons, Gender Disparities and Harassment Persist

MedicalResearch.com – Responses

Marina Stasenko, MD Memorial Sloan Kettering Cancer Center

Dr. Stasenko
Photo: MSKCC

Marina Stasenko, MD
Memorial Sloan Kettering Cancer Center

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

Response: Sexual harassment is a form of discrimination that includes gender harassment, unwanted sexual attention, and sexual coercion. A recent report in Fortune magazine noted that over half of US women have experienced sexual harassment at some point in their lives. Until recently, much of the conversation about sexual harassment in the workplace has been relegated to private discussions behind closed doors. However, the MeToo movement has shined a spotlight on the pervasive nature of sexual harassment in various fields, like media and business world. Although there are more female physicians in practice today than ever before, with women accounting for over 50% of young physicians, sexual harassment and gender disparities continue to plague the field of medicine.

Despite the large female representation, gynecologic oncology is not immune from gender disparities. The Society of Gynecologic Oncology is a professional organization of over 2000 physicians, scientists, allied health professionals, nurses, and patient advocates dedicated to the care of patients with gynecologic cancer. As of 2015, 46% of members of the SGO were women, and that number is steadily growing. SGO leadership is also increasingly female – with 2 of the last 3 presidents being women.

Despite the large female representation, gynecologic oncology is not immune from gender disparities. The 2015 SGO practice survey noted that while 22% of male Gynecologic Oncologists held the rank of professor, only 11% of their female counterparts held the title. They also noted that the mean annual salary for male physicians was nearly 150,000$ greater than salary for female physicians.

Given the fact that there is little objective data on sexual harassment in gynecologic oncology, the objective of our study was to evaluate perceptions of sexual harassment and gender disparities among physician members of the Society of Gynecologic Oncology.

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Larotrectinib (VITRAKVI® ): Efficacy and Safety in Pediatric TRK Fusion Cancer Patients

MedicalResearch.com Interview with:

Douglas S. Hawkins, M.D. Hematology/Oncology Division Chief and Professor Pediatrics at Seattle Children's Hospital University of Washington School of Medicine

Dr. Hawkins

Douglas S. Hawkins, M.D.
Hematology/Oncology Division Chief and Professor
Pediatrics at Seattle Children’s Hospital
University of Washington School of Medicine

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

Response: TRK fusion cancer is caused by a rare genomic alteration called a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

Larotrectinib is a central nervous system (CNS) active, oral and highly selective TRK inhibitor used for the treatment of adult and pediatric patients with solid tumors that have a rare genomic alteration called an NTRK gene fusion. Larotrectinib was approved at the end of 2018 in the U.S. under the brand name VITRAKVI®, with European and worldwide regulatory submissions underway.

At ASCO 2019, we will be presenting results from a new analysis specifically looking at the efficacy and safety of larotrectinib in pediatric patients (n=34) included in the expanded dataset from both adults and children across 24 tumor types, which was presented first at the European Society for Medical Oncology (ESMO) 2019 Annual Meeting.  Continue reading

CLL: Ibrutinib (IMBRUVICA®) Demonstrated Durable Responses for High Risk Patients

MedicalResearch.com Interview with:

Paul M. Barr, M.D. Associate Professor of Medicine and Director of the Clinical Trials Office Director of the Clinical Trials Office Wilmot Cancer Institute

Dr. Barr

Paul M. Barr, M.D.
Associate Professor of Medicine and Director of the Clinical Trials Office
Director of the Clinical Trials Office
Wilmot Cancer Institute 

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

Response: When the study was designed, chronic lymphocytic leukemia (CLL)  treatment options were largely limited to chemotherapy and monoclonal antibodies.

Ibrutinib had shown promise in early studies. The intent was to compare ibrutinib to a standard of care treatment option at that time, of atumumab, in patients with relapsed or refractory disease. The goal of the current analysis is to evaluate the durability of ibrutinib and report the long-term safety results.

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Fewer Oncologists Have Financial Ties to Pharmaceutical Companies

MedicalResearch.com Interview with:
Deborah C. Marshall, MD
Icahn School of Medicine at Mount Sinai

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

Response: Open Payments has brought sweeping change to medicine by introducing transparency to physician relationships with industry. We have seen its impact on oncology through the recent media attention to high-profile physicians in oncology scrutinized for their failure to disclose industry relationships and through the resulting changes to conflict of interest policies of clinical, professional and research organizations in recent months.

We wanted to better understand the impact of Open Payments on individual physician behavior due to the important ethical and policy implications.  We have a cohort of oncology physicians that we followed from the inception of Open Payments to see whether the implementation and increasing awareness of Open Payments have resulted in fewer physicians engaging with industry and has shifted payments towards those considered more appropriate.

The study is important because we evaluate trends at the physician-level to explore the impact of Open Payments on how physicians interact with industry, which is difficult to measure. 

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

Response: The most important finding is that oncology physician interactions with industry are decreasing, which we interpret as being due to the effect of Open Payments.  Notably, we do not see large shifts in the types of payments yet, which suggests that transparency alone may not be enough to significantly alter behavior.  Moreover, while there has been a decrease in oncology physicians interacting with industry, the number and value of these interactions has not shifted greatly, which should reassure those who were concerned that this type of transparency program would have a negative impact on beneficial industry interactions.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: We are likely going to see the continued impact of Open Payments over time as the downstream effects of transparency become apparent, which warrants ongoing attention to help guide future policy-making.  Engaging stakeholders in these discussions, as well as investigating the impact of industry relationships on how physicians are providing care, conducting and reporting research, and educating future doctors are relevant areas of further research.  Also, there is increasing financial interest in oncology so addressing the risk associated with financial interactions with industry and conflicts of interest are more important than ever. 

Citation: 2019 ASCO Annual Meeting  June 1 2019

Trends in financial relationships between industry and individual medical oncologists in the United States from 2014 to 2017: A cohort study.

Author(s): Deborah Catherine Marshall, Elizabeth Stieglitz Tarras, Kenneth Rosenzweig, Deborah Korenstein, Susan Chimonas; Icahn School of Medicine at Mount Sinai, New York, NY; New York University School of Medicine, New York, NY; Memorial Sloan Kettering Cancer Center, New York, NY

https://abstracts.asco.org/239/AbstView_239_258191.html 

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Older Women With Early Breast Cancer May Have A Choice of Radiation Therapy Alone

MedicalResearch.com Interview with:

Manjeet Chadha, MD, MHA, FACR, FASTRO Prof. Radiation Oncology Director of the Department of Radiation Oncology Mount Sinai Downtown 

Prof. Chadha

Manjeet Chadha, MD, MHA, FACR, FASTRO
Prof. Radiation Oncology
Director of the Department of Radiation Oncology
Mount Sinai Downtown 

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

Response: Largely, the goal of cancer care among the elderly is to de-escalate therapy searching for a modality that is both an effective treatment and also associated with minimal toxicity.

Approximately, 30% of new breast cancers diagnosed annually are among women older than 70 years of age. Age-adjusted trends note a relatively higher incidence of stage I breast cancer in women between the ages of 70-74 years. For this group of patients, it is imperative that we take a closer look at the evidence-base for our current practice standards, and evaluate opportunities to improve cancer care delivery in the elderly.

Randomized trials have helped arrive at an acceptance of adjuvant endocrine monotherapy in older patients with ER positive, node negative breast cancer. However, in the older patients high rates of non-compliance to tamoxifen secondary to poor tolerance is widely recognized. Emerging data also detail the side effect profile of aromatase inhibitors. Most commonly observed symptoms of arthralgia, reduced bone mineral density, and increased risk of fractures throughout the duration of treatment are important considerations for an older population. At least a quarter of patients on aromatase inhibitors discontinue therapy specifically due to skeletal events and musculoskeletal symptoms. Overall, the side effects of ET contribute to a high rate of non-compliance and negative impact on patients’ quality of life.

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Circulating DNA Can Indicate Melanoma Treatment Failure

MedicalResearch.com Interview with:

David Polsky, MD, PhDDermatologist and Director of the Digmented Lesion Service

Dr. Polsky

David Polsky, MD, PhD
Dermatologist and Director of the Digmented Lesion Service

Mahrukh M. Syeda, MS
Research Associate

Ronald O. Perelman Department of Dermatology
NYU Langone Health

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

Response: Several studies of metastatic melanoma patients have demonstrated that measuring circulating tumor DNA (ctDNA) associates with their disease burden and survival.  Generally, patients with detectable pre-treatment ctDNA levels and/or detectable ctDNA at various time intervals after starting treatment have shorter survivals than patients with lower pre-treatment or on-treatment ctDNA levels.  Studies have varied in their methods to detect ctDNA, the thresholds chosen to call a sample positive or negative, and the follow up time point for measurement, if any.

In this study, we examined pre-treatment and week 4 on-treatment plasma samples from patients enrolled in Combi-D, the Phase III, randomized, double-blind trial of the BRAF and MEK inhibitors Dabrafenib and Trametinib, which led to FDA approval of the combination therapy for patients with unresectable stage III/IV melanoma.

Only patients with BRAF V600E or V600K mutations identified from tumor genotyping were enrolled in the clinical trial.

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TItan Study: Apalutamide (ERLEADA®) plus Androgen Deprivation Therapy Improved Survival in Some Metastatic Prostate Cancer Patients

MedicalResearch.com Interview with:

Dr. Kim Chi. MDProfessor of MedicineMedical Oncologist and Medical Director at BC Cancer – VancouverUniversity of British Columbia,Principal Investigator of the TITAN Study.

Dr. Kim Chi

Dr. Kim Chi. MD
Professor of Medicine
Medical Oncologist and Medical Director at BC Cancer – Vancouver
University of British Columbia,
Principal Investigator of the TITAN Study.

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

Response: For more than 70 years, androgen deprivation therapy (ADT) has been the standard of care therapy for patients with metastatic prostate cancer. The Phase 3 TITAN study looked at adding apalutamide (®®®®) to ADT compared with placebo plus ADT in a broad group of patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of disease volume or prior docetaxel treatment history.

Metastatic castration-sensitive prostate cancer is prostate cancer that still responds to androgen deprivation therapy and has spread to other parts of the body. Patients with mCSPC tend to have a poor prognosis, with a median overall survival (OS) of less than five years, underscoring the need for new treatment options. The dual primary endpoints of this study were overall survival and radiographic progression-free survival (rPFS).  Continue reading

Prostate Cancer: Novel Androgen Blocker Darolutamide Has Potential to Delay Mets and Extend Survival

MedicalResearch.com Interview with:

Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy

Prof. Fizazi

Prof. Karim Fizazi, MD, PhD
Head of the Department of Cancer Medicine
Institute Gustave Roussy

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

How does darolutamide differ from other medications for prostate cancer?

Response: Despite recent treatment advances, there is still significant unmet need for new therapeutic options for men with non-metastatic castration-resistant prostate cancer (nmCRPC).

In laymen’s terms, nmCRPC is cancer that has not spread beyond the prostate region; PSA levels are elevated, despite treatment with hormone therapy, and men with nmCRPC generally feel well and do not have symptoms. The unmet medical need is for treatments that achieve disease control and delay the spread of the cancer without impacting their daily lives or increasing the burden of disease with treatment side effects.

While the current treatments in this space are effective in delaying onset of metastases, the side effects can be unpleasant and disruptive to men’s lives; particularly cognitive issues, seizures, impact on balance which may lead to falls and bone fractures, rash and hypertension.

Furthermore, new treatment options that have limited interactions with medications typically used in this patient population are also important.  Continue reading

Metastatic Prostate Cancer: Final Analysis of Adding Abiraterone Acetate (ZYTIGA® ) and Prednisone to Androgen Deprivation Therapy

MedicalResearch.com Interview with:
Kim Nguyen Chi, MD FRCPC

Professor of Medicine, University of British Columbia
Regional Medical Director, BC Cancer – Vancouver

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

Response: For over 70 years, androgen deprivation therapy (ADT) has been the main treatment therapy for metastatic prostate cancer patients. This Phase 3 final analysis study looked at adding abiraterone acetate and prednisone to ADT for patients with metastatic prostate cancer, with the primary objectives being to assess improvements in overall survival and radiographic progression-free survival. At the first interim analysis reported in 2017, both primary endpoints were met, and the study was unblinded and patients on the ADT and placebos arm crossed over to receive ADT with abiraterone and prednisone.

This study is the final analysis reporting on overall survival. The study findings found abiraterone acetate and prednisone plus ADT continued to demonstrate an improvement in overall survival, hazard ratio (HR) = 0.66, meaning a 34% decrease in the risk of death associated with the use of ADT with abiraterone and prednisone. The median overall survival, which had not been reached before in the ADT with abiraterone and prednisone arm, was 53.3 months compared to 36.5 months for ADT plus placebo, prolonging median overall survival by 16.8 months.

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Watson for Clinical Trial Matching Increases Enrollment in Breast Cancer Trials

MedicalResearch.com Interview with:

Alexandra Urman, MPH Clinical Research Manager Clinical Development IBM Watson Health 

Alexandra Urman

Alexandra Urman, MPH
Clinical Research Manager
Clinical Development
IBM Watson Health 

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

Response: Cancer statistics show only 3-5% of cancer patients participate in clinical trials although up to 20% may be eligible.

Dr. Tufia Hadad, a medical Oncologist at the Mayo Clinic in Rochester, Minnesota sought to address this issue and spearheaded a project conducted at the Rochester facility in collaboration with IBM Watson Health. The objective was to determine if the use of cognitive computing increased clinical trial enrollment and screening efficiency in the breast cancer clinic.

Watson for Clinical Trial Matching (CTM) is a cognitive system which utilizes natural language processing to derive patient and tumor attributes from unstructured text in the electronic health record that can be further used to match a patient to complex eligibility criteria in trial protocols.

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Radionuclide 177Lu-Dotatate Improves QoL in Patients with Neuroendocrine Tumors

MedicalResearch.com Interview with:

Jonathan Strosberg MD Moffitt Cancer Center Tampa, FL

Dr. Strosberg

Jonathan Strosberg MD
Moffitt Cancer Center, Tampa, FL

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

Response: Neuroendocrine tumor (NET) progression is associated with deterioration in quality of life. We assessed the impact of 177Lu-Dotatate treatment on time to deterioration in health-related quality of life in patients with advanced midgut neuroendocrine tumors in the NETTER-1 study.

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Phase III Trial of YONDELIS® (trabectedin) in Advanced Soft Tissue Sarcoma

MedicalResearch.com Interview with:

Axel Le Cesne, MD Institute de Cancerologie Gustave-Roussy Villejuif, France

Dr. Le Cesne

Axel Le Cesne, MD
Institute de Cancerologie Gustave-Roussy
Villejuif, France

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

Response: With the exception of a study in translocation-related sarcomas (TRS) (Kawai, TLO 2015), trabectedin was never compared to best supportive care (BSC) in a randomized study in patients with all STS histotypes. This trial required by French Health Authorities in 2014.

The tumor control rate after 6 cycles of trabectedin is similar (30%) to previous study in French referral centers (T-DIS trial, Le Cesne, Lancet Oncol 2015) evaluating trabectedin in all subtypes of STS. As already reported, trabectedin was well tolerated with no cumulative toxicities

This study met its first endpoint as a preplanned PFS analysis showed a significant improvement in median PFS with trabectedin  over BSC in patients with pretreated ASTS including multiple histologies (HR: 0.39). A major impact of trabectedin was observed in the L-STS cohort (liposarcomas and leiomyosarcomas) with a median PFS of 1.4 months in the BSC arm and 5.13 m (HR: 0.29, p<0.0001) in the trabectedin arm. respectively). The benefit observed with trabectedin in the L-STS cohort of patients is similar to those observed in the US trial in the same population (4.2 vs 1.5m for DTIC) (Demetri, JCO 2016) and in the Japanese trial mentioned above (5.8 vs 0.9m for BSC) (Kawai, TLO 2015)

After the crossing over allowed by the protocol (trabectedin for patients progressing in the BSC arm), safety and efficacy profiles of trabectedin remains similar. We did not observe a difference in terms of OS between the two arms, probably due to the cross-over planned by the protocol.  Continue reading

First in Class Antibody-Drug Conjugate Shows Promise in Metastatic Breast Cancer

MedicalResearch.com Interview with:

Dr. Aditya Bardia  MD, MPH Assistant Professor, Medicine, Harvard Medical School Attending Physician, Medical Oncology Massachusetts General Hospital

Dr. Bardia

Dr. Aditya Bardia  MD, MPH
Assistant Professor, Medicine
Harvard Medical School
Attending Physician, Medical Oncology
Massachusetts General Hospital

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

Response: Hormone receptor-positive (HR+)/ and human epidermal growth factor receptor 2-negative (HER2-) breast cancer is the most common sub-type of breast cancer. While metastatic HR+/HER2- breast cancer is initially treated with endocrine therapy-based combinations, including CDK 4/6 inhibitors, patients eventually have disease progression, but the response rate to standard chemotherapy is low (~10-15 percent, post-taxane setting). In particular, patients with visceral disease have a poor prognosis.

In this trial, we evaluated the efficacy of sacituzumab govitecan in patients with metastatic HR+/HER2- breast cancer, who had measurable disease and had received prior therapies for metastatic breast cancer. We observed an overall response rate of 31 percent in a heavily pre-treated population (prior number of therapies for metastatic breast cancer = 5; number of patients with prior CDK 4/6 inhibitor use = 69 percent). The responses were durable (median duration of response = 7.4 months). Neutropenia was the main adverse event noted (grade 3 neutropenia = 42 percent), and two patients (3.7 percent) discontinued the clinical trial due to adverse events. The response rate in patients with visceral metastaseswas 27 percent.  Continue reading

Novel SM-88 Therapy Has Potential Efficacy in Metastatic Breast Cancer

MedicalResearch.com Interview with:

Dr. Giuseppe Del Priore, MD, MPH Chief Medical Officer of Tyme Inc. 

Dr. Del Priore

Dr. Giuseppe Del Priore, MD, MPH
Chief Medical Officer of Tyme Inc.

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

Response: Metastatic breast cancer, sometimes also called “stage IV” or “advanced breast cancer,” is the most extensive stage of breast cancer. It is an invasive cancer that has spread to other parts of the body, most often bones, lungs, liver, and brain. The current standard of care for metastatic breast cancer is systemic drug therapies, such as hormone therapy, chemotherapy, targeted drugs or a combination of these.  Because they reach every cell in the body, they have side effects that can worsen the patient’s quality of life. Existing treatments cannot cure metastatic breast cancer and are palliative in intent. This presents a great unmet need and challenge in treating patients with metastatic breast cancer.

SM-88 is a novel relatively non-toxic combination therapy that harnesses cancer’s unique cell metabolism and oxidative stress to selectively drive cancer cell death. Earlier studies with SM-88 therapy demonstrated its potential efficacy in breast and other metastatic cancers. In this current report, we assessed the efficacy of SM-88 in patients with metastatic breast cancer from the first in human “Phase 1” and compassionate use programs from 2012 to 2017. Data demonstrated the potential efficacy of SM-88 in metastatic breast cancer with favorable safety and quality of life profiles. In addition, there were no indications of cross-resistance based on hormone profile, previous treatments or metastatic site. This is an extremely important finding since most cancer deaths are due to resistance to subsequent therapies.  As predicted by the SM-88 mechanism of action, we could not detect this problem with SM-88 use.

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What Surveillance Testing Should Be Done After Melanoma Diagnosis?

MedicalResearch.com Interview with:

This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification.

This image depicts the gross appearance of a cutaneous pigmented lesion, which had been diagnosed as superficial spreading malignant melanoma (SSMM). Note the roughened edges of this mole, and its heterogeneous, mottled, multicolored appearance, which are all characteristics that should evoke suspicions about its classification.
CDC Image

Dr. Diwakar Davar, MD
Assistant Professor of Medicine
Division of Hematology/Oncology
University of Pittsburgh 

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

Response: The optimal surveillance strategy to detect recurrence in cutaneous melanoma remains elusive. Risk of recurrence increases with higher stage, and is especially high for patients with stage IIIC disease. Although consensus guidelines agree on surveillance imaging for high-risk (stage IIB-IIIC) MEL, there is no consensus regarding optimal frequency/modality in these patients. NCCN guidelines suggest chest radiography (CXR) at 6- to 12-month intervals for stage IA-IIA melanoma  patients; although this is controversial. There exists a great deal of practice variation in the surveillance of these patients. Continue reading

Plitidepsin Evaluated for Refractory Multiple Myeloma

MedicalResearch.com Interview with:
PharmaMarDr. Javier Gómez García
Senior Manager. Biostatistics and Data Management
PharmaMar
Madrid Area, Spain

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

Response: Multiple myeloma accounts for approximately 1 percent of all cancers and slightly more than 10 percent of all hematologic malignancies. At present, more than 80,000 new cases are reported worldwide each year, and the disease prevalence is increasing.

Plitidepsin is a synthetic cyclic depsipeptide isolated from the marine tunicate Aplidium albicans targeting the proto-oncogene eEF1A2, which is over-expressed in multiple myeloma cells.

In ADMYRE trial 255 relapsed and refractory multiple myeloma patients with at least three but not more than six prior regimens, including at least bortezomib and lenalidomide/thalidomide, were randomized at 2:1 ratio to receive plitidepsin 5 mg/m2 D1 and 15 plus DXM 40 mg D1, 8, 15 and 22 (P+DXM), or DXM 40 mg D1,8,15 and 22 (DXM) every four weeks.

P+DXM met the primary endpoint, progression-free survival (PFS) assessed by an Independent Review Committee, showing a 35% risk reduction in the probability of progression or death. Indeed, a 20% risk reduction in the probability of death was also observed in spite of the fact that 44% of patients from control arm (DXM) switched to P+DXM arm after progression. Therefore, survival in the control arm might have been extended by the effect of plitidepsin, increasing the post progression survival and overestimating the survival observed in the control arm and consequently underestimating the actual difference between treatment arms.

Several methods were used to assess the impact of crossover and the robustness of the results even when penalizations were applied; PharmaMar believes that strong evidence in terms of survival benefit in favour of P+DXM has been established.  Continue reading

 SM-88 as Potential Alternative to Existing Toxic Treatments for Metastatic Pancreatic Cancer

MedicalResearch.com Interview with:

Dr. Marcus Smith Noel, MD University of Rochester James P. Wilmot Cancer Institute Strong Memorial Hospital

Dr. Smith Noel

Dr. Marcus Smith Noel, MD
University of Rochester James P. Wilmot Cancer Institute
Strong Memorial Hospital

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

Response: Pancreatic cancer outcomes are poor even despite improvement in the overall prognosis for many cancers. Early detection of pancreatic cancer is uncommon because early stage pancreatic cancer often has few symptoms. Unfortunately, most cases are diagnosed at more advanced stages, which is in part why the disease is so lethal. Current standard of care treatments are highly toxic and not effective long-term, as about 90% of patients diagnosed with advanced or metastatic pancreatic cancer do not survive a year.

SM-88 is a relatively non-toxic novel combination therapy designed to utilize cellular metabolism and oxidative stress to drive cancer cell death. This therapy has previously demonstrated activity in various metastatic cancers, such as pancreatic cancer, and is currently being evaluated in an ongoing Phase II trial for metastatic pancreatic cancer.

This study is a trial in progress report of Tyme’s Phase II trial in patients with metastatic cancer. The Phase II trial is designed as an open-label, multi-center study of SM-88 in patients with metastatic pancreatic cancer who have failed at least one prior line of therapy. In the first stage of the trial, 36 patients will be randomized 1:1 to receive a dose of either a currently utilized active regimen or a double dose per day of SM-88. Primary endpoints are overall response rate (ORR) and overall survival (OS). Secondary endpoints include progression-free survival (PFS), disease control rate, duration of response and time to subsequent treatment. The purpose of the first stage of the study is to analyze the safety, efficacy and pharmacokinetics of SM-88 in patients.  The selected dose of SM-88 will be continued into the second stage of the trial for approximately 81 additional patients.

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Combination Therapy Could Dramatically Alter CLL Treatment

MedicalResearch.com Interview with:

Dr. Danelle James,

Dr. James

Dr. Danelle James, M.D., M.A.S.
Head of Clinical Science
Pharmacyclics, an AbbVie Company

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

Response: CAPTIVATE is a Phase 2 study investigating IMBRUVICA (ibrutinib) plus VENCLEXTA (venetoclax) for the treatment of Chronic Lymphocytic Leukemia (CLL) in the first-line setting. It was designed to evaluate if remission with undetectable minimal residual disease (MRD) can provide treatment-naïve CLL/SLL patients with treatment holidays (a period of time when a patient is able to stop therapy). The study enrolled 164 patients with previously untreated CLL or SLL.

In preclinical and ongoing clinical studies, we’ve seen complementary activities with this combination. The combination has also previously shown potential for deeper remissions, as well as potential for lower risk of tumor lysis syndrome with ibrutinib as the lead-in therapy.

Early data from CAPTIVATE show promising activity for the combination in this patient population, with 77 percent of the first 30 patients achieving responses with no detectable MRD in the blood after only six cycles of the combination therapy. Approximately nine out of 10 of the first patients achieved undetectable MRD after 12 cycles of combination therapy (which were preceded by three cycles of single agent ibrutinib, for a total of 15 cycles of therapy). Specifically, 86 percent of the first 14 patients achieved undetectable MRD in the marrow and 93 percent in the peripheral blood.

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YONSA (abiraterone acetate) In Metastatic Castration-Resistant Prostate Cancer

MedicalResearch.com Interview with:

https://www.churchillpharma.com/

Paul Nemeth, Ph.D.
Sr. Vice President, Regulatory Affairs, Clinical Development & Quality Assurance
Churchill Pharmaceuticals LLC
King of Prussia, PA 19406


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

Response: In the STAAR study, 53 patients with metastatic castration-resistant prostate cancer (mCRPC) were randomized to receive YONSA, an abiraterone acetate fine particle formulation 500 mg once daily in combination with 4 mg of methylpresnisolone twice daily or 1,000 mg daily of the originator abiraterone acetate (OAA) in combination with 5 mg of prednisone twice daily for a period of 84 days.  Previous studies in healthy volunteers under fasted conditions had shown that single oral doses of 500 mg of YONSA are bioequivalent to single oral doses of 1,000 mg OAA and that a background of 4 mg of methylprednisolone twice daily on a single oral dose of 500 mg of YONSA results in the same extent of absorption as a background of 5 mg of prednisone twice daily on a single oral dose of 1,000 mg of OAA.  Continue reading

CTC Blood Test Can Reduce Unnecessary Prostate Biopsies in PSA ‘Gray-Zone’

MedicalResearch.com Interview with:
https://cellmaxlife.com/Atul Sharan
Co-Founder & CEO at CellMax 

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

Response: Approximately 30 million men in the United States take the Prostate-Specific Antigen (PSA) screening test. Recent studies published in the Annals of Internal Medicine have established that PSA screenings have resulted in reduced mortality from prostate cancer. However, the problem with the PSA test is that many patients will receive indeterminate results. Only one in five of patients who have taken the test will have a positive biopsy for prostate cancer, but 33 percent of these patients could suffer from biopsy related side effects, and 1 percent will require hospitalization.

This study showed that the CellMax CTC blood test can predict which patients in the gray zone will need/have a positive prostate biopsy with a much lower false positive rate than current standard of care tests, potentially reducing unnecessary biopsies in this group by up to 90 percent. At the same time, the sensitivity of this test at 80 percent was comparable to the current standard of care tests, meaning this test was also accurate in ruling out biopsy in patients. 

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Combination Axitinib + Pembrolizumab Active Against Renal Cell Carcinoma

MedicalResearch.com Interview with:

Prof. Michael B. Atkins, MD Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center William M. Scholl Professor and Vice-Chair Department of Oncology and  Professor of Medicine Georgetown University Medical Cente

Prof. Atkins

Prof. Michael B. Atkins, MD
Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center
William M. Scholl Professor and Vice-Chair Department of Oncology and
Professor of Medicine
Georgetown University Medical Center 

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

Response: Prior studies combining programmed death-1 (PD-1) checkpoint inhibitors with tyrosine kinase inhibitors of the vascular endothelial growth factor (VEGF)-pathway have been characterized by excess toxicity precluding further development. We hypothesized that axitinib, a more selective VEGF inhibitor would combine safely with pembrolizumab (anti-PD-1) and yield antitumour activity in treatment-naïve patients with advanced renal cell carcinoma.

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Liquid Biopsy Results for Cancer Mutations May Differ – Study Compares Idylla platform vs to OncoBEAM RAS CRC assay

MedicalResearch.com Interview with:

Dr. Ana Vivancos, Principal Investigator Cancer Genomics Group Vall d'Hebron Institute of Oncology (VHIO Barcelona 

Dr. Ana Vivancos

Dr. Ana Vivancos PhD, Principal Investigator
Cancer Genomics Group
Vall d’Hebron Institute of Oncology (VHIO
Barcelona 

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

Response: Our study was designed to address a key issue in liquid biopsy testing: analytical sensitivity. We know that mutations in plasma of mCRC patients show a wide range in their allelic frequencies (0.01-90%), the biological basis for which remains unclear. We also know that around 35% of cases show very low mutant allele fractions (MAFs), < 1%, therefore highlighting the need of using high sensitivity techniques in the routine lab in order to properly detect mutations.

We have compared two different testing methods that are being used in liquid biopsy:

Digital PCR (OncoBEAM RAS test, BEAMing) with a limit of detection of 0.02% vs qPCR (Idylla ctKRAS test, Biocartis) with an analytical sensitivity of 1%.

Our findings indicate that detection sensitivity decreases for the qPCR based method in cases with low MAF (<1%) and more so when MAF values are very low (<0.01%).

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BEACON Triplet Therapy for BRAF Mutant Metastatic Colorectal Cancer Shows Promise

MedicalResearch.com Interview with:

Scott Kopetz, M.D., Ph.D., FACP Associate Professor Department of Gastrointestinal Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX

Dr. Kopetz

Scott Kopetz, M.D., Ph.D., FACP
Associate Professor Department of Gastrointestinal Medical Oncology
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, TX

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

Response: The BRAF mutation carries a very poor prognosis for patients with advanced colo-rectal cancer (CRC), and is particularly unresponsive after first-line therapy, so additional treatment options for these patients are needed. While treatment with a BRAF inhibitor alone has not been effective in treating this disease, combination therapies have shown promise and lead to the initiation of the BEACON study. The safety lead-in phase of the BEACON CRC trial was designed to assess the safety and tolerability of encorafenib, binimetinib  and cetuximab triplet combination prior to the Phase 3 randomized portion of the study. Thirty patients were treated in the safety lead-in and received the triplet combination (encorafenib 300 mg daily, binimetinib 45 mg twice daily, and cetuximab per label). Out of the 30 patients, 29 had a BRAFV600E mutation. Microsatellite instability-high (MSI-H) (resulting from defective DNA mismatch repair) was detected in only 1 patient. The triplet demonstrated good tolerability, supporting initiation of the randomized portion of the study. In addition, promising initial clinical activity was observed.

In patients with the BRAFV600E mutation, the estimated median progression-free survival (mPFS) at the time of analysis was 8 months. The confirmed overall response rate (ORR) in patients with the BRAFV600E mutation was 48%, and 3 patients achieved complete responses (CR). Further, the ORR was 62% in the 16 patients (10/16) who received only one prior line of therapy.

Additionally, the triplet combination was generally well-tolerated. Two patients discontinued treatment due to AEs with only one of these considered related to treatment. The most common grade 3 or 4 AEs seen in at least 10% of patients were fatigue (4/30), urinary tract infection (3/30), increased aspartate aminotransferase (AST; 3/30) and increased blood creatine kinase (CK; 3/30).

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Phase I Study Successfully Targets Metastatic Kidney Cancer

MedicalResearch.com Interview with:

Kevin D. Courtney, M.D., Ph.D.  Assistant Professor UT Southwestern Medical Cente

Dr. Courtney

Kevin D. Courtney, M.D., Ph.D. 
Assistant Professor
UT Southwestern Medical Center

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

Response: Clear cell renal cell carcinoma (ccRCC) is the most common form of kidney cancer. Metastatic ccRCC does not respond to traditional chemotherapy.

Current standard treatments for metastatic ccRCC include drugs called vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs) that block the growth of new blood vessels that feed the cancer, as well as drugs that inhibit an enzyme called mTOR that is involved in ccRCC growth and immune therapies that rev up the body’s immune response to try to fight the cancer. Each of these treatments can have significant side effects for patients that can make them difficult to tolerate.

Metastatic ccRCC is largely incurable, and we need novel and better-tolerated treatments. A central driver of ccRCC is a protein called hypoxia inducible factor 2alpha (HIF-2alpha). This protein has been very difficult to try to target with a drug. This study is the first to test a drug that targets HIF-2alpha in patients with metastatic ccRCC. The study results showed that the HIF-2alpha inhibitor, PT2385 (Peloton Therapeutics) was active in fighting metastatic ccRCC and was well-tolerated.

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Patients Prefer Doctors Who Face Them Rather Than Computer Screen

MedicalResearch.com Interview with:
Dr. Ali Haider, MBBS MD

Assistant Professor, Department of Palliative Care and Rehabilitation Medicine
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, TX 

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

Response: Patients with chronic and serious illnesses such as cancer often experience high physical and psychosocial symptoms. Recent studies have reported association of physicians’ examination room computer use with less face to face interactions and eye contact. It’s important for the clinicians to look for certain physical cues to better understand the well being of their patients. Therefore we conducted this randomized clinical trial to understand patients perception of physicians compassion, communication skills and professionalism with and without the use of examination room computer.

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One Year Follow Up of Kisqali® (ribociclib) plus Letrozole in HR+, HER2- Advanced Breast Cancer Demonstrates Continued Efficacy

MedicalResearch.com Interview with:

Gabriel N. Hortobagyi, MD, FACP Professor of Medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, UTMDACC, Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine Program Director, Department of Breast Medical Oncology Susan G. Komen Interdisciplinary Breast Fellowship Program The University of Texas MD Anderson Cancer Center Houston, TX

Dr. Hortobagyi

Gabriel N. Hortobagyi, MD, FACP
Professor of Medicine, Department of Breast Medical Oncology,
Division of Cancer Medicine, UTMDACC,
Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine
Program Director, Department of Breast Medical Oncology
Susan G. Komen Interdisciplinary Breast Fellowship Program
The University of Texas MD Anderson Cancer Center
Houston, TX

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

Response: The MONALEESA-2 trial is a double-blind, randomized, Phase III trial that evaluated efficacy and safety of Kisqali plus letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who had not previously been treated for their advanced disease.

MedicalResearch.com: What are the main findings?

o Updated findings from the Phase III MONALEESA-2 trial confirm the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a treatment option for HR+/HER2- advanced or metastatic breast cancer:
• After nearly one year of additional follow-up, Kisqali plus letrozole demonstrated median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) compared to 16.0 months (95% CI: 13.4-18.2) for letrozole alone.
• The progression-free survival rate at two years was 54.7% in the Kisqali plus letrozole arm compared to 35.9% in patients treated with letrozole alone.
• In women with measurable disease, 55% of patients saw their tumor size shrink by at least 30% (overall response rate (ORR)) compared to 39% of patients with letrozole plus placebo.
• Treatment benefit remained consistent across all patient subgroups regardless of demographics or disease characteristics, including women with visceral disease and those diagnosed de novo.

o The safety profile of Kisqali plus letrozole remained consistent and the incidence of laboratory and electrocardiogram (ECG) irregularities were similar to that observed at the first interim analysis.

• The most common grade 3/4 laboratory abnormalities for Kisqali plus letrozole compared to letrozole alone were decreased neutrophils (62.6% vs 1.5%), decreased leukocytes (36.8% vs 1.5%), decreased lymphocytes (16.2% vs 3.9%) and elevated alanine aminotransferase (11.4% vs 1.2%).

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Clinical Trial Uses Patient’s Own Tumor To Manufacture Anti-Cancer Vaccine

MedicalResearch.com Interview with:
Chrisann Kyi, MD
Fellow, Division of Hematology and Medical Oncology
Icahn School of Medicine at Mount Sinai
One Gustave L. Levy Place, Box 1079
New York, NY 10029

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

Response: Mutation-derived tumor antigens (MTAs or neoantigens) arise as a direct result of somatic mutations, including nucleotide substitutions, insertions, and deletions that occur during carcinogenesis. These somatic variations can be characterized via genetic sequencing and used to identify MTAs with predictive computational genomics and algorithms. To be a good candidate for a cancer vaccine, a mutated cancer protein must be visible and recognized by T cells, the soldiers of the immune system, so that they in turn can be educated to seek out and destroy cancer cells that bear the mutated protein.

At annual ASCO conference this year, we are presenting an exciting clinical trial investigating the feasibility, safety, and immunogenicity of a personalized MTA-based multi-peptide vaccine in the adjuvant treatment for multiple solid tumors.

In this trial, the patient’s own tumor is used to manufacture a cancer vaccine according to the mutations in their individual tumor. This vaccine is then given back to the patient in the adjuvant setting. The clinical trial is currently open and accruing at Tisch Cancer Center at Mount Sinai Hospital, NY

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