FDA Approval Insights: Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer

Welcome to a very special edition of OncLive^® On Air! I’m your host today, Caroline Seymour.

OncLive^® On Air is a podcast from OncLive, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

But today, we had the pleasure of sitting down with Aditya Bardia, MD, MPH, director of Precision Medicine at the Center for Breast Cancer; founding director of the Molecular and Precision Medicine Metastatic Breast Cancer Clinic at Massachusetts General Hospital Cancer Center; and an assistant professor of medicine at Harvard Medical School, to discuss the FDA approval of sacituzumab govitecan (Trodelvy) in metastatic triple-negative breast cancer.

On April 22, 2020, the FDA granted an accelerated approval to the antibody-drug conjugate sacituzumab govitecan for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least 2 prior therapies for metastatic disease. The approval is based on findings from a phase 1/2 study of the ADC in triple-negative breast cancer, that had been published in the New England Journal of Medicine in February 2019. At a median follow-up of 9.7 months, the objective response rate was 33.3% by local assessment with a median duration of response of 7.7 months. The clinical benefit rate, which comprised the objective response rate and stable disease rate, was 45.4%. By blinded independent central review, the objective response rate was 34.3% and the median duration of response was 9.1 months.

In our exclusive interview, Dr. Bardia, the lead study author, shed light on key findings from the trial, the implications of the approval for patients with metastatic triple-negative breast cancer, and ongoing research with sacituzumab govitecan.