FDA Approval Insights: First-Line Sacituzumab Govitecan Plus Pembrolizumab for PD-L1+ TNBC: With Sara M. Tolaney, MD, MPH

In today’s episode, we spoke with Sara M. Tolaney, MD, MPH, about the FDA approval of sacituzumab govitecan plus pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-authorized test. Dr Tolaney is chief of the Division of Breast Oncology and associate director of the Susan F. Smith Center for Women’s Cancers and a senior physician at Dana-Farber Cancer Institute, as well as an associate professor of medicine at Harvard Medical School in Boston, Massachusetts.

This regulatory decision was backed by findings from the phase 3 ASCENT-04/KEYNOTE-D19 trial (NCT05382286), in which the median progression-free survival among patients in the sacituzumab govitecan arm was 11.2 months (95% CI, 9.3-16.7) vs 7.8 months (95% CI, 7.3-9.3) among patients who received physician’s choice of chemotherapy plus pembrolizumab (HR, 0.65; 95% CI, 0.51-0.84; P = .0009).

In our exclusive interview, Dr Tolaney highlighted the significance of this approval, key data from ASCENT-04, and how the TNBC paradigm is shifting to accommodate this new regimen.