AstraZeneca, Author Interviews, Cancer Research, ESMO, Lung Cancer, NEJM, Yale / 08.10.2020

MedicalResearch.com Interview with: Roy S. Herbst, M.D., Ph.D. Ensign Professor of Medicine (Medical Oncology) and 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? How does osimertinib differ from prior versions of EGFR-TKI Inhibitors? o   ADAURA is a randomized, double-blinded, global and placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, and IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated. Patients were treated with osimertinib 80 mg once-daily oral tablets or placebo for three years or until disease recurrence. The primary endpoint is disease free survival (DFS) in Stage II and IIIA patients, and a key secondary endpoint is DFS in Stage IB, II and IIIA patients. Osimertinib is not currently approved in the adjuvant setting in any country. o   Osimertinib is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases. The results of the Phase III ADAURA trial of osimertinib demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer for patients. o   ADAURA results were first presented in May during the American Society of Clinical Oncology ASCO20 Virtual Scientific Program. (more…)
Author Interviews, Cancer Research, Hepatitis - Liver Disease / 07.10.2020

MedicalResearch.com Interview with: Donna R. Cryer, JD President & CEO of the Global Liver Institute  MedicalResearch.com: What is the background for this announcement? What is the mission of the GLI? Response: Global Liver Institute 's (GLI) mission is to improve the impact of the liver community by promoting innovation, collaboration, and scaling optimal approaches to eradicating liver diseases. Our vision is for liver health to take its proper place on the global public health agenda consistent with its prevalence and impact. One of the ways we seek to fulfill that mission is through a #OctoberIs4Livers worldwide awareness campaign for the fight against liver cancer, reinforcing October as liver disease and liver cancer awareness month. Not only are we seeing a continuous rise of prevalence of liver cancers, but survival rates for liver cancers are also some of the lowest of any cancer. Even more concerning is that the startling truth about the rise of liver cancer rates began before the COVID-19 pandemic. With the added burden of COVID-19, patients directly at risk from the virus may be diagnosed at a later stage due to delayed screening, and are getting sicker due to limitations on access to care during this pandemic. GLI is appealing to the US Congress to act now to secure the health and well-being of people living with liver disease and liver cancers during COVID-19. Funding is crucial to ensure federal agencies can restart and continue medical research, implement targeted prevention, and support awareness efforts for those impacted by liver disease as they are at increased risk for severe illness from COVID-19. [1] (more…)
Author Interviews, Biomarkers, Cancer Research / 07.10.2020

MedicalResearch.com Interview with: Padma Sundar, Senior Vice President of Commercial , OncocyteTM oncocyte.com MedicalResearch.com:  What is the background for this announcement? How common is Stage I-IIA non-squamous NSCLC?  DetermaRxTM is a treatment stratification test to identify patients with Stage I-IIA non-squamous NSCLC who may benefit from adjuvant chemotherapy.
  • Stage I-IIA non-squamous NSCLC represents ~20% of the lung cancer population and 40,000 patients annually in the U.S.1
  • Patients with this diagnosis usually undergo surgical resection and are presumed “cured”. While these patients are presumed “cured”, the recurrence rate in early-stage NSCLC of 30-50%. Usually, these recurrences happen within the first two years after surgery and are likely due to the presence of occult distant metastasis at the time of surgery.2
  • Until now, there has not been a validated means of identifying which early-stage patients are at a higher risk of disease recurrence and require adjuvant chemotherapy, versus those patients that are likely cured by surgery alone.
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Author Interviews, Cancer Research, Tobacco Research / 05.10.2020

MedicalResearch.com Interview with: Priti Bandi PhD Principal Scientist, Risk Factors Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Trends in e-cigarette prevalence and population count of users according to cigarette smoking histories are unknown. These data are needed to inform public health actions against a rapidly changing U.S. e-cigarette market. (more…)
Author Interviews, Cancer Research, Prostate Cancer / 01.10.2020

MedicalResearch.com Interview with: Maha Hussain, MD, FACP, FASCO Genevieve Teuton Professor of MedicineDivision of Hem/Onc Deputy Director Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine MedicalResearch.com: What is the background for this study? Response: PROfound is an open-label international Phase III clinical trial which evaluated the efficacy and safety of Olaparib (Lynparza) versus enzalumatide or abiraterone and prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior treatment with NHA treatments (abiraterone and prednisone or enzalutamide) and have a qualifying tumor mutation in BRCA1/2, ATM or one of the other genes involved in the HRR pathway. The trial design included 2 cohorts; Cohort A included patients with BRCA1,2 or ATM and Cohort 2 included patients with 12 other HRR genes. (more…)
Author Interviews, Cancer Research, HPV, Karolinski Institute, NEJM, Vaccine Studies / 30.09.2020

MedicalResearch.com Interview with: Dr. Jiayao Lei PhD Prof. Pär Sparén PhD Karolinski Institute MedicalResearch.com: What is the background for this study? Response: The efficacy and effectiveness of quadrivalent HPV (qHPV) vaccine protecting against HPV infection, genital warts and high-grade precancerous cervical lesions have been shown. However, there is lack of population-based studies in examining the association between HPV vaccine and invasive cervical cancer on individual level.  (more…)
Author Interviews, Cancer Research, ESMO, Race/Ethnic Diversity, Social Issues / 21.09.2020

MedicalResearch.com Interview with: Ziad Bakouny, MD, MSc Post-doctoral research fellow Lank Center for Genitourinary Oncology Dana-Farber Cancer Institute MedicalResearch.com: What is the background for this study? Response: The COVID-19 pandemic has disproportionately affected patients with cancer, with these patients unfortunately having worse outcomes than the general population. In fact, a recent report by the COVID-19 and Cancer Consortium (CCC19) showed that the mortality rate in patients with cancer who develop COVID-19, at 30 days median follow-up, was 16%. Although the adverse outcomes of patients with cancer who develop COVID-19 has received much attention, few studies have thus far investigated the effects of the potential disruption to cancer care delivery caused by the pandemic. Our aim in the COVID and Cancer Outcomes Study (CCOS) was therefore to evaluate this disruption to cancer care caused by the pandemic. This is a multicenter prospective cohort study that included patients seen in the outpatient setting at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai in New York City and the Dana-Farber Cancer Institute in Boston during one week in March (between March 2 and March 6 2020). Data was collected 3 months before this index week and 3 months prospectively (during the first peak of the pandemic in the Northeastern United States). (more…)
Author Interviews, Cancer Research, ESMO / 21.09.2020

MedicalResearch.com Interview with: Guy Jerusalem MD PhD Medical Oncology, CHU Sart Tilman Liège and University of Liège Liège/BE MedicalResearch.com: What is the background for this study? Response: COVID-19 pandemic impacted healthcare systems globally and resulted in the interruption of usual care in many healthcare facilities exposing vulnerable cancer patients to significant risks. Our study aimed to evaluate the impact of this pandemic on cancer care worldwide. A 95 items survey was constructed and distributed worldwide by 20 oncologists from 10 of the most affected countries. 109 representatives from oncology centers in 18 countries filled out the survey between June 17 and July 14. (more…)
Author Interviews, Cancer Research / 17.09.2020

MedicalResearch.com Interview with: Dr. Arvin C. Dar, PhD Associate Professor Departments of Oncological Sciences & Pharmacological Sciences Tisch Cancer Institute Icahn School of Medicine at Mount Sinai Associate Director Mount Sinai Center for Therapeutic Discovery MedicalResearch.com: What is the background for this study? Response: We were interested in better understanding the mechanism of action for the drug trametinib. We wanted to understand how the drug actually works – even though its clinically approved, the drug was a ‘serendipitous discovery’ and originally found through phenotypic screens. (more…)
Author Interviews, Cancer Research, Dermatology, Pediatrics / 16.09.2020

MedicalResearch.com Interview with: Irene Lara-Corrales, MD Associate Professor of Pediatrics at the University of Toronto Staff physician in Pediatric Dermatology at the Hospital for Sick Children in Toronto, Canada She is a member of the Society for Pediatric Dermatology.   Christina Boull, MD Assistant Professor of Dermatology at the University of Minnesota Program Director for the Advanced Dermatology Medical Student Rotation Fellowship Director for the Pediatric Dermatology Fellowship     MedicalResearch.com: What is the background for this study? Response: We got involved in this project a couple of years ago when many members of the Pediatric Dermatology Research Alliance's (PeDRA) Skin Tumors and Reactions to Cancer Therapies (STARC) group started seeing many patients with skin toxicities given by targeted therapies.  We recognized that this was a new and growing area of skin concerns that pediatric dermatologists were starting to see. Being such a new field, and with little known about these medications, we thought it would be important to put our cases together and describe what we were seeing.   (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology / 09.09.2020

MedicalResearch.com Interview with: Jennifer Huang, MD  Dr. Huang is a pediatric dermatologist at Boston Children’s Hospital and Dana-Farber Cancer Institute. She is an Associate Professor of Dermatology at Harvard Medical School. Dr. Huang is a member of the Society for Pediatric Dermatology. Connie Zhong, MD, MSc Dr. Zhong is an intern at Brigham and Women’s Hospital She will be doing her dermatology residency at the Harvard Combined Dermatology Program. She is a member of the Society for Pediatric Dermatology.  MedicalResearch.com: What is the background for this study? Response: Pediatric nonmelanoma skin cancers (NMSC) are rare and when they do occur, are often associated with genetic/predisposing skin conditions or iatrogenic risk factors. There are some pediatric patients who develop NMSCs who do not have identifiable risk factors. The objective of our study was to describe the demographic and clinical features of these children without identifiable risk factors and compare them with those who have either genetic or iatrogenic risk factors. We conducted a retrospective study at 11 tertiary care institutions across North America through the Pediatric Dermatology Research Alliance (PeDRA) (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology / 03.09.2020

MedicalResearch.com Interview with: Yin Zhang MD Research Fellow in Medicine Brigham and Women's Hospital and Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Among modern hair dyes, permanent hair dye is the most popular type, and is the most aggressive and extensively used type that has posed the greatest potential concern about cancer risk. Monitoring and investigating the carcinogenic hazard to people from personal use of permanent hair dyes has major public health implications. In 2008, the World Health Organization's International Agency for Research on Cancer, after comprehensive reviewed prior evidence, classified occupational exposure to hair dyes as a probable carcinogen to humans (group 2A), whereas personal use of hair dyes was not classifiable as to its carcinogenicity to humans (Group 3). Data on hair dye safety has also been continuously monitored by the USFDA. Prior epidemiological evidence may have been influenced by not discriminating between personal and occupational exposure, an inability to distinguish types and colors of hair dyes used, imprecise assessment of several critical domains of exposure history (duration, frequency and cumulative dose), and inadequate control for potential confounding. (more…)
Author Interviews, Biomarkers, Cancer Research / 20.08.2020

MedicalResearch.com Interview with: Dr. Alexey Aleshin, M.D., MBA Senior Medical Director Natera MedicalResearch.com: What is the background for this study? Response: Checkpoint inhibitor-based immunotherapies (ICI)  have changed the management of a range of cancers of diverse histologies. While these therapies are well tolerated and efficacious, only a minority (<20%) of patients respond to treatment or derive durable clinical benefit from them, highlighting the need for a pan-cancer biomarker that can predict response prior to, or shortly after, treatment initiation. With immune checkpoint inhibitors (ICIs) rapidly becoming a cornerstone of cancer therapy, early determination of response to ICI treatment can optimize patient benefit and minimize the risk of toxicities, while potentially reducing unnecessary treatment and costs to patients and payers. Additionally, due to the nature of immune checkpoint inhibition, atypical patterns of response have emerged. For instance, tumor pseudoprogression — a transient increase in tumor size due to the infiltration of immune cells, followed by delayed shrinkage — has been reported in as much as 10% of patients receiving ICI therapy. Distinguishing pseudoprogression from true progression is clinically important to avoid premature discontinuation of a treatment that may have future benefit, or delay the initiation of an alternative line of therapy. However, they are hard to differentiate using current imaging techniques. Our study published in Nature Cancer earlier this month, demonstrates that bespoke circulating tumor DNA (ctDNA) testing may be a valuable tool that sheds light on both of these issues. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology, JAMA / 14.08.2020

MedicalResearch.com Interview with: Maryam M. Asgari, MD MPH Professor Department of Dermatology, Massachusetts General Hospital Department of Population Medicine, Harvard Medical School MedicalResearch.com: What is the background for this study? What are Topical Calcineurin Inhibitors used for?  Response: Topical calcineurin inhibitors (TCIs) are FDA approved for the treatment of atopic dermatitis (though they are used off-label to treat a wide range of inflammatory conditions of the skin, including psoriasis, seborrheic dermatitis, and contact dermatitis).  There are currently two drugs available – tacrolimus and pimecrolimus – both of which carry a black box label warning users about the potential for increased skin cancer risk.  The risk associated with keratinocyte carcinoma, the most common cancer (defined as basal cell carcinoma and squamous cell carcinoma), remains poorly defined because findings from large-scale post-marketing surveillance studies are lacking.  (more…)
Author Interviews, Cancer Research, Nature, Technology / 06.08.2020

MedicalResearch.com Interview with: Moritz Gerstung PhD Group Leader: Computational cancer biology EMBL-European Bioinformatics Institute MedicalResearch.com: What is the background for this study? Response: We have learned a lot in the last ten years about the molecular nature about various cancers thanks to the resources created by TCGA, ICGC and many other initiatives. Similarly, digital pathology has progressed hugely due to new AI algorithms. Yet it hasn’t been explored deeply how a cancer’s genetic makeup and its histopathological appearance are related. Here computers can be very helpful as they can process large amounts of digital microscopy slide images and test whether there are any recurrent histopathological patterns in relation to hundreds or thousands of genetic and other molecular abnormalities.  (more…)
Author Interviews, Cancer Research, COVID -19 Coronavirus, JAMA / 04.08.2020

MedicalResearch.com Interview with: Harvey W. Kaufman, MD, MBA, FCAP Senior Medical Director, Medical Informatics Quest Diagnostics Needham, MA  MedicalResearch.com: What is the background for this study? Response: The COVID-19 pandemic has disrupted routine healthcare and in particular cancer screenings.  We documented the impact on patients who were newly identified by cancer in the early months of the pandemic by analysis of Quest Diagnostics data. MedicalResearch.com: What are the main findings?  Response: We saw a 46% decline in newly identified patients with six common types of cancer.  In accordance to healthcare recommendations, many patients didn’t receive mammograms, colonoscopies, low-dose CT scans, and avoided physician visits for minor complaints.  When these patients return, some will present with more advanced stages of cancer than they would have without the disruption of the pandemic.  (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dental Research, Esophageal, Gastrointestinal Disease / 24.07.2020

MedicalResearch.com Interview with: Mingyang Song, MD, ScD. Division of Gastroenterology Clinical and Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School Department of Nutrition and Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: Recent studies showed a presence of dysbiotic oral microbiome in patients with esophageal and gastric cancer, suggesting a link between oral health and these cancers. However, how periodontal disease and tooth loss may influence the risk of these cancers has been inconsistent.  MedicalResearch.com: What are the main findings? Response: Our findings support a possible role of oral health in the development of upper GI cancer. Individuals with periodontal disease and tooth loss are at higher risk of developing esophageal and gastric adenocarcinoma. The risk is particularly high for individuals with both periodontal disease and tooth loss.  (more…)
Author Interviews, Breast Cancer, Cancer Research, Genetic Research, Ovarian Cancer / 22.07.2020

MedicalResearch.com Interview with: Prof Ranjit Manchanda MD, MRCOG, PhD Professor of Gynaecological Oncology & Consultant Gynaecological Oncologist NHS Innovation Accelerator (NIA) Fellow Integrated Academic Training Programme Director London Specialty School of Obstetrics & Gynaecology, Health Education England Specialty Research Lead for Gynaecological Cancer, NIHR, North Thames Clinical Research Network Cancer Research UK, Barts Centre | Queen Mary University of London Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine | Charterhouse Square | London Department of Gynaecological Oncology | Barts Health NHS Trust, Royal London Hospital MedicalResearch.com: What is the background for this study? Response: Around 10–20% of ovarian cancers and 6% breast cancers overall are caused by inheritable BRCA1/BRCA2 mutations. Women carrying BRCA1/BRCA2 mutations have a 17–44% risk of ovarian cancer and 69–72% risk of breast cancer until age 80 years. Most of these cancers can be prevented in unaffected BRCA1/BRCA2 women carriers. Women can opt for a range of options including screening, preventive, and reproductive choices to minimise their risk. The current approach uses established clinical-criteria/family-history (FH) based a priori BRCA probability thresholds to identify high-risk individuals eligible for BRCA testing. However, this requires individuals and health practitioners to recognise and act on a significant FH. BRCA carriers, who are unaware of their FH, unappreciative of its risk/significance, not proactive in seeking advice, or lack a strong FH (small families/paternal inheritance/chance) get excluded. Over 50% BRCA carriers do not fulfil clinical criteria and are missed. Despite >25 years of BRCA testing and effective mechanisms for prevention, current guidelines and access to testing pathways remain complex and associated with a massive under-utilisation of genetic testing. Only 20% of eligible women have accessed/undergone genetic testing and our earlier analysis showed that 97% of BRCA carriers in the population remain unidentified. Current detection rates are inadequate to identify all BRCA carriers and even doubling detection rates will not work. Why should we wait for decades for people to develop cancer before identifying BRCA carriers and unaffected at-risk family members to offer prevention?. This highlights substantial missed opportunities for early detection and prevention. A new population testing approach can change this. Jewish population studies show this is feasible, acceptable, has high satisfaction (91–95%), significantly reduces anxiety, doesn’t harm psychological well-being or quality of life, and is extremely cost-effective. However, this has not been evaluated in the general population and in particular across different  countries or health systems. The potential applicability and scope for this approach transcends continents and countries. Additionally, for interventions to be sustainable, they need to be cost-effective and affordable. We have undertaken a cost-effectiveness analysis of population based BRCA testing compared with current standard clinical testing of women designated as high risk, across high income countries (UK/USA/Netherlands), upper-middle income countries (China/Brazil), and low-middle income country (India). (more…)
AACR, Author Interviews, Cancer Research / 16.07.2020

MedicalResearch.com Interview with: Radek Spisek MD PhD Charles University in Prague  MedicalResearch.com: What is the background for this study? Response: Immune cytokine IL-15 is a highly promising immuno-oncology target that mobilizes the two most important cell types driving anti-cancer immune responses: cytotoxic T cells and natural killer (NK) cells. Stimulating IL-15 receptors on these cells represents a potent and complementary mechanism to existing cancer treatments, such as PD-1 checkpoint inhibitors or monoclonal antibodies. Sotio is developing an IL-15 superagonist, SO-C101, as a potent immunotherapy for patients with cancer. This study examined SO-C101 in multiple tumor mouse models alone and in combination with PD-1 inhibition.  (more…)
Author Interviews, Biomarkers, Cancer Research / 28.06.2020

MedicalResearch.com Interview with: Dr. Kathryn Lang VP, Outcomes and Evidence Guardant Health  MedicalResearch.com: What is the background for this study? Response: Despite a wide variety of screening methods available and increasing public awareness of the value of early detection, colorectal cancer (CRC) remains a leading cause of cancer-related deaths.  However nearly 1 in 3 adults in the United States  is not compliant with screening recommendations, with most citing that current screening methods are time consuming, unpleasant (stool-based testing), and in the case of colonoscopy, invasive. A blood-based CRC screening test could improve compliance rates by providing physicians with an opportunistic, in-office screening modality. However, demonstrating the clinical utility of blood-based cell-free circulating tumor DNA (ctDNA) fractions  for the detection of cancer in asymptomatic individuals has thus far been challenged by the failure to achieve clinically meaningful sensitivity and specificity thresholds due to significantly lower tumor cell-free free DNA  fractions and the increasing relevance of biological confounders. The multi-modal approach of Guardant Health’s LUNAR-2 assay (genomics, methylation and fragmentomics) coupled with advanced bioinformatic analysis and a focused approach of honing in on the unique signals of CRC  has been shown in previously reported cohorts to perform with sensitivity and specificity which satisfies the needs of clinicians in screening for CRC. (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, Colon Cancer / 26.06.2020

MedicalResearch.com Interview with: Guardant HealthVan Morris, M.D. Department of Gastrointestinal Medical Oncology Division of Cancer Medicine MD Anderson Center MedicalResearch.com: What is the background for this study? Response: Stage II colon cancer is diagnosed in approximately 25% of all colon cancer cases.  Oncologists do not have a reliable biomarker to identify patients who do or do benefit from adjuvant chemotherapy for this population of patients.  Circulating tumor DNA is shed by tumor cells as they die and harbors somatic mutations which distinguish its DNA from that of normal cells. Recently, circulating tumor DNA has shown great promise in distinguishing patients with colon cancer (as well as other solid tumors) that do or do not recur after surgery.  Here, patients who have detectable circulating tumor DNA - a surrogate for the presence of microscopic, minimal residual disease – inevitably recur, whereas the likelihood of recurrence is much lower for patients who do not have detectable ctDNA. (more…)
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.]
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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, 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, 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…)