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, JAMA / 13.03.2020

MedicalResearch.com Interview with: Alyson Haslam, PhD Nutritional Epidemiologist Center for Indigenous Health Research and Policy Oklahoma State University MedicalResearch.com: What is the background for this study? Response: Checkpoint inhibitor drugs for the treatment of cancers have received a lot of attention in recent years because of their ability to induce responses in certain tumors. To quantify the eligibility and response of these drugs in the US population, we published an article about a year ago (https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2732329). Since that publication, there were several confirmatory studies that failed to show a benefit in important outcomes such as overall survival or progression-free survival, and the US FDA made some revisions to certain checkpoint inhibitor drug labels. This prompted us to re-evaluate the eligibility of these drugs. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, FDA, JAMA, Pharmacology / 29.05.2019

MedicalResearch.com Interview with: Bishal Gyawali MD PhD
  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada
MedicalResearch.com: What is the background for this study? What are the main findings? Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists. Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review. Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market. (more…)
Author Interviews, Cancer Research, FDA, JAMA / 01.04.2019

MedicalResearch.com Interview with: Emerson Chen, MD Chief Fellow, Hematology-Oncology, PGY-6 Oregon Health & Science University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many cancer drugs are approved annually giving the appearance of innovation; however, some drugs may have been approved because of a lower bar. Use of lesser endpoints like response rate (how tumor shrinks) and progression-free survival (how tumor has delayed growth) have been proposed to speed trials when compared against traditional endpoints like overall survival (how long patients might live). Using published trials that led to cancer drug approval from 2006 to 2017, we estimated how long it would take to get each of these three endpoints across all cancer drugs and indications to see how much time we could save by using these weaker but faster endpoints. We see that many trials using overall survival used less time than anticipated, and many trials using response rate or progression-free survival actually took quite a bit of time. In part that is due to researchers needing to document the duration of the response. But, whatever the reason, the time to get each of the three endpoints is actually more similar than different, and we estimate that our current use of these faster endpoints are saving us only 11 months compared to using only overall survival. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmacology / 12.10.2016

MedicalResearch.com Interview with: Dr. Sham Mailankody, MBBS Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? Response: The high price of older drugs has been increasingly criticized in part because of recent dramatic price hikes. There are some well known examples like pyrimethamine and more recently EpiPen. Whether and to what degree examples like pyrimethamine represent a common problem or exceptional cases remains unknown. Using Medicare data available for Part B, we sought to analyze the change in average sales price of cancer drugs between January 2010 and January 2015, and whether older drugs were more likely to undergo price increases than newer drugs. (more…)