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measure of the program’s success is the fact that, to date, no solid tumor accelerated-approval indications have been withdrawn (Abstract DC06).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
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).
The ASCO Post Staff
Silvia C. Formenti, MD, of Weill Cornell Medicine, discusses research on the best way to integrate radiotherapy with immune modifiers, which might require changes in standard radiation oncology practices. Variables such as the type of treatment fields, the inclusion of draining nodal stations, the degree of exposure of circulating immune cells, the type of dose fractionation, and the timing of radiotherapy during immune checkpoint blockade all can affect the success of immunoradiotherapy combinations (Abstract SY43).
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
Priscilla K. Brastianos, MD, of Harvard Medical School and Massachusetts General Hospital, talks about her efforts to better understand how brain metastases evolve genomically and to test such agents as abemaciclib, paxalisib, and entrectinib, which may stop their growth. Palbociclib, a CDK inhibitor, has already shown potential benefit. A national cooperative group trial is underway in multiple centers to identify novel treatments for patients with brain metastases, who typically have a poor prognosis (Abstract SY38).
