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measure of the program’s success is the fact that, to date, no solid tumor accelerated-approval indications have been withdrawn (Abstract DC06).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
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
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
Lillian L. Siu, MD, of Canada’s Princess Margaret Cancer Centre, discusses biomarker-driven precision cancer medicine, the optimal sequencing of immunotherapy (IO) with standard treatments in curative settings, IO targets beyond PD-1/PD-L1 and combinatorial strategies, and next-generation adoptive cell therapies (Abstract PL06).
The ASCO Post Staff
Timothy A. Yap, MBBS, PhD, of The University of Texas MD Anderson Cancer Center, discusses how research is building on the success of first-generation PARP inhibitors in the clinic and the potential of novel potent PARP1-selective inhibitors, which may lead to improved patient outcomes. Given recent advances in drug discovery, says Dr. Yap, we now can go beyond PARP by drugging other key DNA damage response targets in the clinic, including ATR, WEE1, DNA-PK, RAD51, POLQ, and USP1.
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).
