Dr. Graff on the FDA Approval of Sacituzumab Govitecan in TNBC

Stephanie L. Graff, MD, director of the Breast Program at the Sarah Cannon Cancer Institute of HCA Midwest Health and associate director of the Breast Cancer Research Program at Sarah Cannon Research Institute, discusses the FDA approval of sacituzumab govitecan-hziy (Trodelvy) in metastatic triple-negative breast cancer (TNBC).

On April 22 2020, the FDA granted an accelerated approval to the antibody-drug conjugate (ADC) sacituzumab govitecan for the treatment of adult patients with metastatic TNBC who have received at least 2 prior therapies for metastatic disease. The approval is based on data from a phase I/II study, in which, at a median follow-up of 9.7 months, the objective response rate (ORR) was 33.3% by local assessment (95% CI, 24.6%-43.1%) with a median duration of response of 7.7 months (95% CI, 4.9-10.8). The clinical benefit rate (ORR plus stable disease) was 45.4%.

In January 2019, the FDA issued a complete response letter to Immunomedics regarding its biologics license application (BLA) for sacituzumab govitecan as a treatment for patients with metastatic TNBC who have received at least 2 prior therapies, citing chemistry, manufacturing, and control matters. Prior to that, the FDA had granted a priority review designation to the BLA for the ADC in July 2018, which was based on phase II results. The data showed that sacituzumab govitecan demonstrated an objective response rate of 34% in this patient population.

Graff explains that Sarah Cannon Research Institute was one of the centers with patients with metastatic TNBC enrolled on the sacituzumab govitecan trial. The long-term outcomes demonstrated with this drug have been “remarkable,” she says. This will now be another tool in the physician’s armamentarium to manage TNBC.