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measure of the program’s success is the fact that, to date, no solid tumor accelerated-approval indications have been withdrawn (Abstract DC06).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
Marcia R. Cruz-Correa, MD, PhD, of the University of Puerto Rico Comprehensive Cancer Center, discusses a way to possibly transform cancer outcomes by teaming up basic scientists, clinical researchers, and community advocates to work together, decode the complexity of cancer, and find points at which to intervene in the development of tumor cells. One strong focus is on communities disproportionately affected based on their genomic ancestry, geographic location, and ethnicity (Abstract PL06).
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
Klaus Pantel, MD, of the University Medical Center Hamburg-Eppendorf, discusses liquid biopsy technologies and biomarkers, with a focus on circulating tumor cells and circulating tumor DNA; clinical applications such as early detection of cancer, improved staging, and surveillance of measurable residual disease; and how best to detect and monitor response to systemic therapies, as well as ways to identify therapeutic targets and resistance mechanisms (Abstract SY08).
The ASCO Post Staff
Timothy A. Yap, MBBS, PhD, of The University of Texas MD Anderson Cancer Center, discusses results from the PETRA study, a first-in-class, first-in-human trial of the next-generation PARP1-selective inhibitor AZD5305 in patients with BRCA1/2, PALB2, or RAD51C/D mutations in advanced or metastatic ovarian cancer, HER2-negative breast cancer, pancreatic, or prostate cancer. Target engagement was demonstrated across all dose levels, and antitumor activity was observed in selected tumor and molecular subtypes.
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).
