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measure of the program’s success is the fact that, to date, no solid tumor accelerated-approval indications have been withdrawn (Abstract DC06).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
Tina Cascone, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses the findings of the phase II NeoCOAST study, which showed that combination immunotherapy with the anti–PD-L1 monoclonal antibody durvalumab and other novel agents resulted in numerically higher major pathologic response rates than durvalumab alone in the neoadjuvant setting for patients with early-stage resectable non–small cell lung cancer. Translational results also supported combination therapies over single-agent therapy (Abstract CT011).
The ASCO Post Staff
Ari M. VanderWalde, MD, MPH, MBioeth, of The West Clinic, discusses results from the S1616 trial involving patients with metastatic or unresectable melanoma who had primary resistance to PD-1 or PD-L1 inhibitors. Compared with ipilimumab alone, the combination of ipilimumab plus nivolumab benefited some patients: those with tumors that responded to therapy showed an increased amount of CD8+ cells. Because there is no standard treatment for metastatic melanoma after failure of PD-1 inhibitors in BRAF wild-type disease, this research may provide a viable option in the future (Abstract CT013).
The ASCO Post Staff
Nickolas Papadopoulos, PhD, of the Sidney Kimmel Comprehensive Cancer Center, discusses early detection as the key to reducing cancer mortality and the lack of tests for many malignancies. Liquid biopsies have the potential to screen for various tumor types, albeit with varying levels of sensitivity. Dr. Papadopoulos discusses his research on such blood tests, following patients prospectively to find the best combination of genetic and epigenetic biomarkers to increase sensitivity (Abstract PL02).
The ASCO Post Staff
Josh Neman, PhD, of the Keck School of Medicine, University of Southern California, discusses the distribution of brain metastasis to preferential brain regions that vary according to cancer subtype, how neurotransmitters respond, and the ways in which the central nervous system acclimates (Abstract SY32).
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).