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measure of the program’s success is the fact that, to date, no solid tumor accelerated-approval indications have been withdrawn (Abstract DC06).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 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
Gulam A. Manji, MD, PhD, of Columbia University Medical Center, discusses phase II results on perioperative combination chemotherapy and pembrolizumab in patients with resectable gastric cancer. The combination appeared to result in many complete pathologic responses (Abstract CT009).
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
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).
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).
