Gautam Mehta, MD, on Precision Oncology: An Overview of the Accelerated Approval Program
AACR Annual Meeting 2022
Gautam Mehta, MD, of the U.S. Food and Drug Administration, discusses how accelerated approval of potentially life-saving cancer therapies has been applied in precision oncology. Although “fast-tracking” drugs presents opportunities and challenges, one possible measure of the program’s success is the fact that, to date, no solid tumor accelerated-approval indications have been withdrawn (Abstract DC06).
The ASCO Post Staff
Timothy A. Yap, MBBS, PhD, of The University of Texas MD Anderson Cancer Center, discusses results from a phase Ib expansion trial of the safety and efficacy of the oral ataxia telangiectasia and Rad3-related (ATR) inhibitor elimusertib in advanced solid tumors with DNA damage response defects. Elimusertib is a selective inhibitor of ATR, a key regulator of responses to DNA damage and replication stress, with antitumor activity in preclinical models of various solid tumors and lymphoma (Abstract CT006).
The ASCO Post Staff
Benoit You, MD, PhD, of the Lyon University Hospital (France), discusses phase I/II safety and efficacy results from the ENDOLA trial that combined olaparib with metronomic cyclophosphamide and metformin in patients with advanced pretreated endometrial cancer. At 10 weeks, the non–disease progression rate was 61.5%, reaching the primary endpoint of the study. Median progression-free survival was 5.1 months. Research on biomarkers of efficacy is ongoing (Abstract CT005).
The ASCO Post Staff
Zev Wainberg, MD, of the University of California, Los Angeles Medical Center, discusses preliminary data on the safety and efficacy of TTX-030, an anti-CD39 antibody, in combination with budigalimab and FOLFOX for the first-line treatment of locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. The study suggests the regimen may prove to be of benefit as a first-line treatment, regardless of combined positive score status (Abstract CT015).
The ASCO Post Staff
David A. Barbie, MD, of Dana-Farber Cancer Institute, discusses his laboratory’s studies, showing that malignant pleural mesothelioma, an inflamed cancer type with marginal response to immune checkpoint blockade, demonstrated high tumor cell STING expression and response to STING agonists in combination with natural killer cell therapies ex vivo. STING is the tumor cell stimulator of interferon genes (Abstract 4168).
The ASCO Post Staff
Vivek Subbiah, MD, of The University of Texas MD Anderson Cancer Center, talks about innovative design of clinical studies that may help demonstrate clinical benefit in precision medicine and advance treatment to deliver the right intervention to the right patient at the right time (Abstract DC06).
