Dana-Farber Research Supports FDA Approval of New First-Line Therapy for Metastatic Triple-Negative Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved the antibody-drug conjugate sacituzumab govitecan for first-line treatment of metastatic triple-negative breast cancer.

By
June 24, 2026
4 min

Dana-Farber

Objective:

To report on the FDA approval of sacituzumab govitecan as a first-line treatment for metastatic triple-negative breast cancer based on clinical trial results.

Approach:

ASCENT-03 Study: Enrolled 558 patients with locally advanced or unresectable triple-negative breast cancer not candidates for immune checkpoint inhibitors, comparing sacituzumab govitecan to chemotherapy.
ASCENT-04 Study: Enrolled 443 patients, comparing sacituzumab govitecan plus pembrolizumab to chemotherapy plus pembrolizumab.

Key Findings:

In ASCENT-03, median progression-free survival was 9.7 months for sacituzumab govitecan versus 6.9 months for chemotherapy.
In ASCENT-04, median progression-free survival was 11.2 months for the sacituzumab govitecan combination versus 7.8 months for the chemotherapy combination.
Nearly 60% of patients responded to the sacituzumab govitecan combination with a median duration of response of 16.6 months.