Author Interviews, Cancer Research, Leukemia / 16.06.2020

MedicalResearch.com Interview with: Courtney D. DiNardo, M.D., MSCE Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center MedicalResearch.com: What is the background for this study? Response: At this year’s virtual European Hematology Association (EHA) meeting, we are presenting late-breaking data from the Phase 3 VIALE-A trial. The randomized double-blind, placebo-controlled trial evaluated venetoclax in combination with azacitidine in previously-untreated patients with acute myeloid leukemia (AML) who are ineligible for standard induction therapy compared to azacitidine plus placebo.  (more…)
ASCO, AstraZeneca, Author Interviews, Cancer Research, Melanoma / 13.06.2020

MedicalResearch.com Interview with: Yuanbin Chen, MD, PhD Cancer & Hematology Centers of Western Michigan MedicalResearch.com: What is the background for this study? What are the main findings?
    • Response: The CASPIAN trial was a randomized, open-label, multi-center global Phase III trial in the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). The trial compared IMFINZI in combination with etoposide and either carboplatin or cisplatin chemotherapy, or IMFINZI and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone – the primary endpoint being overall survival (OS). After a median follow up of more than two years, the latest results for IMFINZI plus chemotherapy demonstrate a sustained and clinically meaningful OS benefit for patients with extensive-stage small cell lung cancer (ES-SCLC), maintaining a 25% reduction in the risk of death versus chemotherapy alone. Updated median OS was 12.9 months versus 10.5 for chemotherapy.
      • In a post-hoc analysis, 22.2% of patients treated with IMFINZI plus chemotherapy remained alive after 24 months, versus 14.4%, for chemotherapy alone.
      • Post-hoc analysis also showed that for IMFINZI plus chemotherapy, 11.0% of patients were alive and progression-free at 24 months versus 2.9% for chemotherapy alone.
      • IMFINZI plus chemotherapy maintained a high confirmed objective response rate (ORR) (68% versus 58%) and in a post-hoc analysis, duration of response (DoR) for IMFINZI at 24 months was 13.5% versus 3.9% for chemotherapy alone.
      • At 24 months, 12% of patients in the IMFINZI plus chemotherapy arm remained on IMFINZI treatment.]
(more…)
ASCO, AstraZeneca, Author Interviews, Cancer Research, Lung Cancer, Yale / 13.06.2020

MedicalResearch.com Interview with: Roy S. Herbst, MD, PhD Ensign Professor of Medicine (Medical Oncology) Professor of Pharmacology Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director for Translational Research Yale Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings?
  • ADAURA is the first global trial for an EGFR tyrosine kinase inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of Stage IB, II, and IIIA EGFRm NSCLC. The results demonstrated unprecedented disease free survival (DFS) in the adjuvant treatment of these patients after complete tumor resection with curative intent. Osimertinib was assessed against placebo for a treatment duration of up to three years and then unblinded two years earlier than expected at the recommendation of the Independent Data Monitoring Committee (IDMC), based on its determination of overwhelming efficacy during a planned safety analysis.
  • In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant (after surgery) treatment with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001).
  • DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).
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ASCO, Author Interviews, Cancer Research / 12.06.2020

MedicalResearch.com Interview with: Alex Spira, MD, PhD, FACP Medical Oncologist Virginia Cancer Specialists and Chair of the US Oncology Research Executive Committee MedicalResearch.com: What is the background for this study? Would you explain what the conjugate consists of and what types of cancer it may target? What are the main findings? Response: The concept of the CX072 and CX2029 studies is that they use what’s called a probody molecule that gets broken down only at the tumor site. This is completely novel in that it helps diminish toxicity by not having less systemic absorption. In the case of CX2029, this target was previously undruggable, meaning the systemic toxicity was too high. By limiting it to activity at the tumor, that is significantly abated.   (more…)
ASCO, Author Interviews, OBGYNE, Ovarian Cancer / 12.06.2020

MedicalResearch.com Interview with: Robert L. Coleman, MD, FACOG, FACS Chief Scientific Officer US Oncology Research MedicalResearch.com: What is the background for this study? Response: For years, there has been general support for surgery in patients with recurrent ovarian cancer supported by reams of retrospective studies that suggest patients live longer if they have surgery preceding chemotherapy. Suggested hypotheses from these trials were that patients most likely to benefit from the procedure were those with good performance status (could tolerate the procedure), had long platinum-free interval (surrogate for potential for chemotherapy response) and those in whom all disease could be resected. Each of these are also characteristics that would portend a good prognostic cohort in general and would likely do better than other patients without these characteristics. So there was a strong selection bias in these retrospective surveys. Thus, the call for randomized trials. GOG-213 was launched in 2007 with 2 primary endpoints: 1. Determine the impact of adding bevacizumab to paclitaxel/carboplatin in patients with platinum-sensitive recurrent ovarian cancer, and 2. Determine if surgery increases overall survival. (more…)
ASCO, Author Interviews, Cancer Research, Colon Cancer / 04.06.2020

MedicalResearch.com Interview with: Salvatore Siena, MD Director, Falck Division of Medical Oncology Department of Hematology and Oncology, and Niguarda Cancer Center Grande Ospedale Metropolitano Niguarda, Milano, I Full Professor of Medical Oncology, Department of Oncology and Hemato-Oncology Università degli Studi di Milano   MedicalResearch.com: What is the background for this study? Response: There remains a significant unmet clinical need in treating patients with HER2 positive advanced colorectal cancer (CRC) who progressed on previous therapies. Exploratory clinical studies in CRC with HER2-amplification documented that patients with tumors with this molecular characteristic may benefit from HER2-targeted therapies  (reviewed in Siena S et al Ann Oncol 2018). In particular, the phase 1 DS8201-A-J101 dose-expansion study of the cohort of patients with HER2 expressing non-breast/non-gastric or HER2 mutant solid tumors who received the 6.4 mg/kg dose of T-DXd, there were 20 patients with CRC. In this studythe experimental drug T-DXd (trastuzumab deruxtecan) showed clinical benefit and manageable safety profile.
  • Investigator-assessed ORR (Objective Response Rate) of 15.0% (95% CI, 3.2-37.9), DCR (Disease Control Rate) of 80.0% (95% CI, 56.3-94.3), and median PFS (Progression Free Survival) of 4.1 months (95% CI, 2.1-5.9) was reported
  • Common TEAEs (Treatment Emergent Adverse Events) include gastrointestinal (low grade) and hematological, which is consistent with overall T-DXd safety profile across various tumors
  • ILD (Interstitial Lung Disease) was reported in 2 patients (Tsurutani et al. 2020)
Given the unmet need in the treatment of patients with HER2 positive advanced CRC who progressed on previous therapies and the clinical observations from the phase 1 DS8201-A-J101 study (see previous paragraph) , the phase 2 DESTINY-CRC01 trial was conducted to evaluate the efficacy and safety of T-DXd in patients with HER2 expressing CRC who were previously treated with at least 2 lines of therapy.  (more…)
ASCO, AstraZeneca, Author Interviews, Breast Cancer, Cancer Research / 02.06.2020

MedicalResearch.com Interview with: Josefa Briceno, MD Medical Head, DDR/ADC Franchise AstraZenca  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In January 2018, the US FDA expanded the approved use of LYNPARZA to treat patients with HER2- negative metastatic breast cancer with germline BRCA mutations based on positive results from the Phase III OlympiAD trial, which demonstrated the benefit of LYNPARZA over standard of care in physician’s choice chemotherapy in this patient population. LUCY is a Phase IIIb interim analysis aimed to evaluate the clinical effectiveness and safety of LYNPARZA in a real-world setting and has been expanded to include a group of patients with somatic BRCA mutations. A total of 252 patients with HER2-negative metastatic breast cancer with germline BRCA mutations were enrolled in the open-label, single-arm, Phase IIIb study. Patients received a taxane and/or anthracycline in the (neo)adjuvant/metastatic setting, and ≤2 lines of chemotherapy. The primary end point of the study was investigator-defined progression-free survival (PFS), and secondary end points included overall survival, time to first subsequent therapy or death, and investigator-assessed clinical response rate. The interim analysis was planned to take place after 160 progression-free survival events. Overall, treatment lasted for a median of 7.9 months, and the median progression-free survival was 8.1 months (95% confidence interval of 6.9-8.7; 166 progression-free survival events). In addition, the median time to first subsequent therapy or death was 9.7 months (95% confidence interval of 8.7-11.1) and the investigator-assessed clinical response rate was 48.6% (95% confidence interval of 42.2-55.0). Adverse events of all grades were reported in >20% of patients were nausea, anemia, asthenia, vomiting, and fatigue. Grade ≥3 adverse events were reported in 24.6% of patients, and 4.4% of patients had an adverse event that led to treatment discontinuation. (more…)
ASCO, AstraZeneca, Author Interviews, Cancer Research, Ovarian Cancer / 02.06.2020

MedicalResearch.com Interview with: Mark Sims US Franchise Head Women’s Cancer & DNA Damage Response AstraZeneca  MedicalResearch.com: What is the background for this study? What are the main findings? Response: SOLO2 is a Phase III, randomized, double-blind, multicenter trial designed to determine the efficacy and safety of LYNPARZA tablets as a maintenance monotherapy compared with placebo, in patients with platinum-sensitive relapsed or recurrent gBRCA-mutated (BRCAm) ovarian cancer. The trial included 295 patients with germline BRCA1 or BRCA2 mutations who had received at least 2 prior lines of platinum-based chemotherapy and were in complete or partial response. The trial met its primary endpoint in October 2016, showing maintenance treatment with LYNPARZA significantly improved progression-free survival to a median of 19.1 months vs 5.5 months with placebo (a hazard ratio of 0.30; a 95% confidence interval of 0.22 to 0.41; a p value of <0.0001). (more…)
ASCO, Author Interviews, Cancer Research / 30.05.2020

MedicalResearch.com Interview with: Cardinale Smith, MD, PhD Associate Professor Medicine, Hematology and Medical Oncology and Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai New York  MedicalResearch.com: What is the background for this study? Response: Cancer patients are often hospitalized with complications from cancer and cancer treatment. Physical decline is common among hospitalized cancer patients and contributes to poorer outcomes including increased length of stay, excess days, readmissions and patient experiences.  Therefore, increased activity and mobilization during hospitalization are essential to prevent functional decline. Whereas previous research has focused on risk factors that limit mobility and interventions for enhancing mobility in well-functioning, community dwelling older adults, there have been limited interventions on the mobility of hospitalized cancer patients. (more…)
ASCO, Author Interviews, Biomarkers, Breast Cancer / 30.05.2020

MedicalResearch.com Interview with: Francois-Clement Bidard, MD PhD Head of Breast Cancer Group, Institut Curie Professor of Med. Oncology, UVSQ/Paris MedicalResearch.com: What is the background for this study? Response: A timely question is how to optimize the endocrine therapy of ER+ HER2- metastatic breast cancers? Aromatase inhibitors (AI) are currently the standard of care in first line, in combination with CDK4/6 inhibitors. Mutations in the estrogen receptor gene (ESR1) can be detected in up to 40% of AI-resistant metastatic breast cancers, but no data was available in the current first line setting (AI combined to CDK4/6 inhibitor). This exploratory study of the first line PADA-1 study reports on the detection rate of ESR1 mutations in cell-free DNA from an “AI-sensitive” population (with no metastatic relapse during adjuvant AI therapy), before the start of therapy (at inclusion). As expected, we found a low prevalence of 3.2% in the general population (N=1,017 patients included). The prevalence of ESR1 mutations among subgroups appeared primarily driven by the type of adjuvant endocrine therapy: patients with prior exposure to adjuvant therapy with AI displayed the highest prevalence of ESR1 mutations (7.1%), followed by patients with no prior adjuvant endocrine therapy (mostly de novo stage IV; ESR1 mutation prevalence: 2.4%). Patients who received adjuvant endocrine therapy with no AI (e.g. tamoxifen only) had the lowest ESR1 mutation prevalence (1.2%). (more…)
ASCO, Author Interviews, Cancer Research, Electronic Records / 30.05.2020

MedicalResearch.com Interview with: Debra A. Patt, MD, PhD, MBA, FASCO Editor-in-chief of the Journal of Clinical Oncology - Clinical Cancer Informatics Medical oncologist at Texas Oncology, and US Oncology Research Breast Cancer Committee member MedicalResearch.com: What is the background for this study? Response: Cancer care is increasing in complexity with differentiation of cancer subtypes, new treatments, and treatment sequences and combinations.  Complying with evidence based therapy has become an increasing challenge.  We see that compliance with guideline based care across the country is highly variable. Our study evaluated an electronic health record based Clinical Decision Support System to facilitate compliance with evidence based guidelines--or pathways--to deliver care to adult patients with cancer. (more…)
ASCO, Author Interviews, Cancer Research, Leukemia, UC Davis / 28.05.2020

MedicalResearch.com Interview with: Brian A. Jonas, M.D., Ph.D. UC Davis Health System MedicalResearch.com: What is the background for this study? At this year’s American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) virtual meetings, we presented data on the rapidity and likelihood of response to venetoclax treatments, and its associated characteristics, in older patients with newly diagnosed acute myeloid leukemia (AML). We evaluated data from two clinical trials of venetoclax in combination with azacitidine, or decitabine (M14-358), or low-dose cytarabine (LDAC) (M14-387) in this patient population. (more…)
Author Interviews, Cancer Research, JAMA, Yale / 28.05.2020

MedicalResearch.com Interview with: Daniel J. Boffa, MD Associate Professor of Thoracic Surgery Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: The study examined networks that formed around hospitals that had been previously ranked in the top-50 by US News and World Report.  These top-ranked hospitals have shared their brand with hospitals in their network, which leads some people to believe that the care is the same at top-ranked hospitals and their affiliate hospitals.  We wanted to determine if outcomes after complex surgical procedures were truly the same at affiliate hospitals and top-ranked hospitals.  (more…)
Annals Internal Medicine, Author Interviews, Colon Cancer / 26.05.2020

MedicalResearch.com Interview with: Dr. Nastazja Dagny Pilonis, MD Maria Sklodowska-Curie Memorial Cancer Center Institute of Oncology, Warsaw, Poland MedicalResearch.com: What is the background for this study? Response: Currently recommended 10-year interval between screening colonoscopies is based on the limited evidence. We decided to assess what is the risk of colorectal cancer and colorectal cancer death after singe negative screening colonoscopy. (more…)
Author Interviews, Cancer Research, Melanoma, Nature / 21.05.2020

MedicalResearch.com Interview with: Dr. Kelly Brooks PhD Research Officer QIMR Berghofer Medical Research Institute     MedicalResearch.com: What is the background for this study? Response: There are approximately 175 new cases a year for melanomas inside the eye called uveal melanomas. These cancers spread to other sites of the body in about half of patients. Uveal melanomas are very different to skin melanomas and so far no effective treatment have been approved to treat uveal melanoma once it has spread. We sequenced uveal melanoma tumours from over 100 different patients to look at what mutations are responsible for tumour growth and development.  (more…)
Author Interviews, Cancer Research, COVID -19 Coronavirus / 19.05.2020

MedicalResearch.com Interview with: Paolo A. Ascierto, MD Melanoma. Cancer Immunotherapy and Development Therapeutics Unit Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" Napoli - Italy  MedicalResearch.com: What is the background for this study? What are the main findings? Response: As we know, in Covid-19 pneumonia, especially in its complication “acute respiratory distress syndrome (ARDS)”, a key role is played by the immune system. We know that when we treat a tumor with immunotherapy, it could give side effects because the stimulated immune system produces a series of substances to destroy the tumor. Sometimes, the immune system can also give side effects related to a hypersecretion of some cytokines, such as IL 6, the target of tocilizumab. This condition is called cytokine storm, or better, cytokine release syndrome (CRS).Oncologists use tocilizumab in the management of CRS that can occur following the use of bispecific antibodies, or recently, the use of CAR-T cell therapy, where such drug is approved for CRS treatment.  (more…)
Author Interviews, Cancer Research, Lancet, Nature / 19.05.2020

MedicalResearch.com Interview with: Matthew Galsky, MD Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Response: Standard first-line treatment for metastatic urothelial (bladder) cancer has been platinum-based chemotherapy for decades. In 2016, atezolizumab, an immunotherapy that inhibits PD-L1, received accelerated approval by the FDA for the treatment of metastatic urothelial cancer for patients progressing despite prior platinum-based chemotherapy and this was followed by approvals for 4 additional PD-1 or PD-L1 inhibitors in this setting over the next couple years. With this first new drug class approved, representing the first new drugs approved for metastatic urothelial cancer for decades, logical question arose (a) should we combine these drugs with platinum-based chemotherapy in the first-line metastatic treatment setting and (b) is there a role to replace first-line chemotherapy with atezolizumab monotherapy. The IMvigor 130 trial was designed to address these questions. The trial enrolled 1213 patients who were randomized to treatment with (a) atezolizumab plus platinum-based chemotherapy, (b) placebo + platinum-based chemotherapy, or (c) atezolizumab monotherapy. The trial employed a hierarchical analysis plan such that comparisons between arms for certain endpoints could only be formally tested if other the preceding comparisons demonstrated a significant improvement.  (more…)
ASCO, Author Interviews, Cancer Research / 19.05.2020

MedicalResearch.com Interview with: Dr. Jesus G. Berdeja, MD Director of Myeloma Research Sarah Cannon Nashville, TN MedicalResearch.com: What is the background for this study? Response: Despite many advances in the treatment of multiple myeloma in recent years, the majority of patients will progress through all available therapies and ultimately succumb to their disease.  Thus there is still a high unmet medical need. The Phase 1b/2 CARTITUDE-1 study evaluates the safety and efficacy of JNJ-4528, an investigational BCMA-directed CAR-T therapy, in the treatment of patients with relapsed or refractory multiple myeloma. Participants in this study have already tried approved therapies, and had received a median of five prior treatment regimens and their median overall survival is less than 12 months.  (more…)
Author Interviews, Diabetes, Genetic Research, Pancreatic / 15.05.2020

MedicalResearch.com Interview with: Dr. Núria Malats, MD PhD, Head of the Genetic and Molecular Epidemiology Group Spanish National Cancer Research Centre (CNIO)  MedicalResearch.com: What is the background for this study? Response: The high mortality of pancreatic cancer is a consequence of late diagnosis because of the absence of symptoms in the earliest stages, and defining risk populations is therefore crucial to be able to carry out diagnostic tests that reveal the presence of the tumour as early as possible. Diabetes and pancreatic cancer are connected because the pancreas secretes insulin; in diabetic people, this does not occur in a normal way. It is estimated that around 50% of patients with pancreatic cancer presents diabetes. But it is an outstanding challenge for researchers to figure out which is the cause and which is the consequence.  To conduct the study, the team used data from more than 3,500 persons from PanGenEU, a large European study involving centres from six countries, including Spain, and led by Malats, to analyse the relationship between multiple risk factors and pancreatic cancer. (more…)
Author Interviews, Cancer Research, COVID -19 Coronavirus / 14.05.2020

MedicalResearch.com Interview with: AVM BiotechologyTheresa A. Deisher, Ph.D Founder and CEO Chariman of Board AVM Biotechnology Dr. Deisher discusses AVM Biotechnology’s plan to study the immune stimulator AVM0703, developed for it’s anti-tumor effects,  as a potential agent to combat COVID-19.  MedicalResearch.com: What is the background for this study? What is AVM0703 currently being studied to treat?   Response: Our lead small molecule, AVM0703, is a novel, patent-pending repurposed formulation of an active pharmaceutical ingredient that has been U.S. Food and Drug Administration (FDA)-approved since 1961. AVM0703 works by supercharging and mobilizing immune cells, including a novel natural killer T-cell (NKT), novel cytotoxic T lymphocytes and a CD11b very high dendritic cell, which invade and destroy tumors more effectively than untreated immune cells. AVM Biotechnology has received clinical trial approval from the FDA to begin Phase I/II trials to characterize the safety, tolerability, pharmacokinetics, and antitumor activity of AVM0703 administered as a single intravenous infusion to pediatric and adult patients (≥12 years old) with terminal, no-option lymphoid malignancies. In addition, we are planning to study AVM0703 in Phase I/II trials in patients with severe or life-threatening COVID-19 infection. The proposed study is a randomized, double-blind, placebo-controlled, single-ascending dose study of AVM0703 administered as a single intravenous infusion. The study’s objective is to evaluate the safety and efficacy of AVM0703 in patients with COVID-19, as well as assess pharmacokinetics and dosing, including the maximum tolerated dose and the recommended Phase II dose. We hope to begin recruiting patients next month (June 2020). (more…)
Author Interviews, Cancer Research, Genetic Research, JAMA / 14.05.2020

MedicalResearch.com Interview with:
  • Sung Jun Ma, MD, resident physician in Radiation Medicine at Roswell Park Comprehensive Cancer Center (first author)
  • Oluwadamilola T. Oladeru, MD, a resident physician at Massachusetts General Hospital Cancer Center
MedicalResearch.com: What is the background for this study? Response: More than 40% of women with hormone receptor-positive, HER2-negative early-stage breast cancer have high recurrence scores (RS) of 26-30. Optimal adjuvant systemic therapy in this subgroup remains unclear, and national guidelines currently recommend either chemoendocrine therapy or endocrine therapy alone. In addition, the difference in overall survival of a patient with a RS 26-30 versus RS >30 is unclear. (more…)
AACR, Author Interviews, Boehringer Ingelheim, Cancer Research / 13.05.2020

MedicalResearch.com Interview with: Dr. Udai Banerji, MD The Institute of Cancer Research and The Royal Marsden MedicalResearch.com: What is the background for this study? Response: Not only have I been working in the RAS mutations oncology world for a while, but I also have prior preclinical experience working with VS-6766 (RAF/MEK inhibitor) and defactinib (FAK inhibitor), the two drugs in the Phase 1 study that was presented at the American Association for Cancer Research (AACR) annual medical meeting on April 27th. It is important to know that there is a great significant medical need for novel treatments for KRAS mutant tumors, which are difficult to treat, aggressive, and quite common across advanced solid tumors, including low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), resulting in the need for novel treatments in an area of significant medical need. I felt that early signals in preclinical research warranted a clinical trial; so that, combined with my RAS experience, made pursuing the Phase 1 study a clear fit. A clinical trial setting allowed us to explore RAF and RAS inhibitor combinations in multiple tumor trials, which was our aim. The data presented at AACR convey safety and dose response results from the dose-escalation portion and expansion cohorts from an open-label, investigator-initiated Phase 1 study evaluating the combination of VS-6766 (RAF/MEK inhibitor) and defactinib (FAK inhibitor) therapy in patients with LGSOC and KRAS mutant NSCLC. The introductory data described in the study suggest that a novel intermittent dosing schedule of RAF/MEK and FAK inhibitor combination therapy has promising clinical activity in patients with KRAS mutant LGSOC and KRASG12V mutant NSCLC, including patients formerly treated with a MEK inhibitor. Expansion cohorts remain ongoing.  (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies / 09.05.2020

MedicalResearch.com Interview with: David S Hong, M.D MD Anderson Department of Investigational Cancer Therapeutics Division of Cancer Medicine University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated robust tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. In this analysis presented at AACR 2020, we sought to evaluate the outcomes in patients from the integrated data set based on different baseline characteristics, including prior lines of therapy and Eastern Cooperative Oncology Group (ECOG) performance status. ECOG measures how the disease impacts a patient. ECOG describes a patient’s level of functioning with a numbering scale (0-5) so physicians can uniformly describe a patient’s ability to care for themselves, daily activity and physical activity (selfcare, walking, working, etc). (more…)
AACR, Author Interviews, Bayer, Cancer Research / 08.05.2020

MedicalResearch.com Interview with: David S Hong, M.D Department of Investigational Cancer Therapeutics Division of Cancer Medicine MD Anderson, University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. A variety of NTRK genes have been identified in various tumor types including fusions and non-fusions (e.g., amplifications, rearrangements, deletions, slice variants). In the analysis presented at AACR 2020, we sought to evaluate this pooled data to determine the efficacy of larotrectinib in patients with non-fusion alterations in NTRK genes.  (more…)
Author Interviews, Breast Cancer, Cancer Research, Genetic Research, JAMA / 08.05.2020

MedicalResearch.com Interview with: Anurag K. Singh MD Professor of Oncology Director of Radiation Research Leader, Cell Stress and Biophysical Therapy Program Associate Dean Graduate Medical Education, Research Roswell Park Comprehensive Cancer Center Buffalo NY MedicalResearch.com: What is the background for this study? Response: More than 40% of women with hormone receptor-positive, HER2-negative early stage breast cancer with high recurrence scores (RS) have RS of 26-30. Optimal adjuvant systemic therapy in this subgroup remains unclear, and national guideline currently recommends either chemoendocrine therapy or endocrine therapy alone. In addition, the difference in overall survival of a patient with a RS 26-30 versus RS >30 is unclear.   (more…)
Author Interviews, Colon Cancer, Gastrointestinal Disease, Infections / 08.05.2020

MedicalResearch.com Interview with: Ulrik Stenz Justesen, MD, DMSc Senior consultant at Department of Clinical Microbiology Odense University Hospital Denmark  MedicalResearch.com: What is the background for this study? Response: Anaerobic bacteria are bacteria that do not require oxygen for energy production, and live in various environments including the human gut, where they usually do not cause infections directly. Previous studies have reported an association between bacteria from the Bovis group streptococci, Clostridium septicum and colorectal cancer (CRC). Recently associations between different Bacteroides species., Fusobacterium nucleatum and CRC have also been reported. We aimed to investigate this further in a large-scale study.  (more…)
Author Interviews, Dermatology, Melanoma / 08.05.2020

MedicalResearch.com Interview with: Neelam A. Vashi, MD Associate Professor of Dermatology Director, Boston University Center for Ethnic Skin Director, Cosmetic and Laser Center Boston University School of Medicine and Daniela P.Sanchez BS Boston Medical Center Boston, MA 02118 MedicalResearch.com: What is the background for this study? Response: Although melanoma most commonly affects Caucasians, Hispanics are disproportionately affected by greater morbidity and mortality rates when diagnosed. Poor prognosis in Hispanic patients is likely multifactorial, and may be secondary to lack of knowledge or misconceptions about melanoma risk, atypical presentation, impaired access to care, and language barriers, ultimately resulting in a delay in diagnosis. (more…)
Author Interviews, Cancer Research, JAMA / 04.05.2020

MedicalResearch.com Interview with: Emerson Y. Chen, MD Assistant Professor of Medicine, Medical Oncology Knight Cancer Institute, Oregon Health & Science University Portland, OR 97239 MedicalResearch.com: What is the background for this study? Response: Our research group had previously studied how oncology drugs are approved in these two previous papers listed below. One is focused on the time delay trade-off from surrogate endpoints (i.e. response rate and progression-free survival) over definite endpoints (i.e. overall survival and quality of life). The other is focused on how promising the response rate of a drug candidate have to be to be considered for oncology drug approval.  (more…)
Author Interviews, Cancer Research, Genetic Research / 04.05.2020

MedicalResearch.com Interview with: Rebecca Nagy Vice President Medical Affairs Guardant Health  MedicalResearch.com: What is the background for this study? Response: Hormone receptor positive (HR+) breast cancer comprises roughly 75% of all cancers of the  breast. While many of these cancers can be cured through multi-modality therapy, there remain many deaths due to metastatic spread to distant organs. These metastatic cancers are marked by their resilience in the face of potent targeted therapies and chemotherapies, with many tumors displaying an initial drug response followed by resistance. Recently, genomic sequencing has identified recurrent, oncogenic alterations in HR+ metastatic breast cancer (MBC) with mutations in the catalytic alpha subunit of PI3K (PI3Kα, PIK3CA gene), in over 40% of cases. This has raised hopes for more durable disease control through precise inhibition of this driver oncogene. The SOLAR-1 Phase III study of alpelisib combined with fulvestrant in PIK3CA-mutated HR+ MBC showed a markedly improved PFS over fulvestrant monotherapy but pervasive resistance nonetheless. To characterize the basis for such resistance to combination hormone plus PIK3CA targeted therapy, we conducted a detailed, longitudinal analysis of tumor and plasma circulating cell-freetumor DNA (ctDNA) among patients with HR+ MBC who participated in a phase I/II dose escalation study of alpelisib in combination with letrozole or exemestane.  (more…)