Results for 'melanoma'
Carrie Printz
First person profile: William Sellers, MD
William Sellers, Dana Farber Cancer Institute, Harvard, melanoma
Dr. Sellers is a prominent figure in cancer research, associated with the Broad Institute of MIT and Harvard, Dana-Farber Cancer Institute, and Harvard Medical School. He has contributed significantly to cancer genomics, particularly in identifying EGFR mutations in lung cancer a…
Nov 6th • 2 mins read
Jayson L. Parker, Sebnem S. Kuzulugil, Kirill Pereverzev, Stephen Mac, Gilberto Lopes, Zain Shah, Ashini Weerasinghe, Daniel Rubinger, Adam Falconi, Ayse Bener, Bora Caglayan, Rohan Tangri, Nicholas Mitsakakis
Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis
biomarker, clinical trial, failure, analysis, NSCLC, oncology
Data from clinical trials across four oncology indications (breast cancer, NSCLC, melanoma, and colorectal cancer) from 1998 to 2017 were analyzed to assess drug approval likelihood based on biomarker status. Using multi-state Markov models, which describe stochastic processes, the study…
Feb 23rd • 8 mins read
Kenji Omae, Yuki Kataoka, Yasushi Tsujimoto, Yusuke Tsutsumi, Yosuke Yamamoto, Shunichi Fukuhara, Toshi A Furukawa
Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation
Anticancer drugs, Clinical trials, Drug approval, Immune checkpoint inhibitors, Publications, United states food and drug administration
The study investigates the publication status of clinical trials for anticancer drugs approved by the FDA, focusing on immune checkpoint inhibitors (ICPis). Data from ICPis approved between 2011 and 2014 was analyzed, revealing that 58% of ICPis trials were published within two years …
Oct 24th • 18 mins read
M. Ochoa de Olza, M. Oliva, C. Hierro I. Matos, J. Martin-Liberal, E. Garralda
Early-drug development in the era of immuno-oncology: are we ready to face the challenges?
immunotherapy, early-drug development, toxicology studies, dose determination
The classical development of drugs is being replaced by a seamless drug-development process. First-in-human trials now often include large expansion cohorts to quickly identify early signs of activity and achieve rapid regulatory approval. Intense competition among pharmaceutical companies and t…
Jun 26th • 26 mins read
Louis Everest, BSc; Monica Shah, BSc; Kelvin K.W. Chan, MD, MSc, PhD
Comparison of Long-term Survival Benefits in Trials of Immune Checkpoint Inhibitor vs Non-Immune Checkpoint Inhibitor Anticancer Agents Using ASCO Value Framework and ESMO Magnitude of Clinical Benefit Scale
immunotherapy-triggered LTP, RCTs, FDA, ICI
Importance: Anticancer agents, especially immune checkpoint inhibitors (ICIs), have shown potential for long-term durable survival in some patients. However, traditional clinical benefit measures may not accurately capture this, leading to proposed amendments in valuation frameworks. Objectives: …
Jul 10th • 12 mins read
Sarah A. Weiss, MD, and Harriet Kluger, MD
CheckMate-067: Raising the Bar for the Next Decade in Oncology
checkmate-067, nivolumab, oncology, relativity-047
Historically, few effective systemic therapies were available for advanced melanoma, but recent advancements have led to significant progress. In 2015, the US FDA approved the combination of ipilimumab and nivolumab based on the results of the CheckMate-067 trial. CheckMate-067 demonstrated lo…
Dec 2nd • 2 mins read
Kristina Jenei, BSN, MS, Daniel E. Meyers, MD, MS, Vinay Prasad, MD, MPH
The Inclusion of Women in Global Oncology Drug Trials Over the Past 20 Years
inclusion, woman, global, oncology drug trials, NIH
Women represented 77% of newly diagnosed thyroid cancer cases in 2020 but only comprised 51% of participants in related trials. Women accounted for 48% of global colon cancer cases but only 33% of trial participants for colon cancer therapeutics. Higher enrollment of women in NIH-funded studies …
Aug 26th • 2 mins read
Alyson Haslam, PhD; Vinay Prasad, MD, MPH
Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs
checkpoint inhibitor drugs, immunotherapy drugs, FDA, checkpoint, inhibitor, drugs
If FDA-approved checkpoint inhibitor drugs are universally available, we estimated that the proportion of US patients with cancer who could be eligible for such drugs is approximately 44%, while approximately 13% have a response to these drugs. These estimates, although modest, are better than estim…
May 3rd • 10 mins read
Talal Hilal, MD; Mohamad Bassam Sonbol, MD; Vinay Prasad, MD, MPH
Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration
RCTs, FDA, clinical trials, anticancer, suboptimal control arms
The aim of our analysis was to evaluate the quality of control arms in RCTs leading to anticancer drug approvals by the FDA. We found that, between January 1, 2013, and July 31, 2018, FDA approval of 16 (17%) of 95 anticancer drugs for the market were based on RCTs with sub-optim…
May 2nd • 15 mins read