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measure of the program’s success is the fact that, to date, no solid tumor accelerated-approval indications have been withdrawn (Abstract DC06).
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).
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).
Jia Luo, MD, of Dana-Farber Cancer Institute, discusses the emerging class of cancer therapies for allele-specific KRAS inhibitors and the importance of their distinct clinical, genomic, and immunologic features. Because KRAS G12D–mutated non–small cell lung cancer is associated with worse responses to immunotherapy, Dr. Luo believes drug development will need to take these differences into account (Abstract 4117).
Iván Márquez-Rodas, MD, PhD, of Spain’s Hospital General Universitario Gregorio Marañón, discusses final results of the phase II SPOTLIGHT203 study of systemic pembrolizumab in combination with intratumoral BO-112 for patients with advanced melanoma refractory to anti–PD-1–based therapy. The regimen achieved an overall response rate of 25% and a disease control rate of 65% (Abstract CT014).
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).