FDA Approves New First-Line TNBC Regimen

Phase 3 results showed longer progression-free survival with pembrolizumab plus sacituzumab govitecan-hziy than with pembrolizumab plus chemotherapy in previously untreated PD-L1-positive advanced triple-negative breast cancer.

By
Kathryn Wighton
June 26, 2026
3 min

MDSpire News

Objective:

To report the FDA approval of pembrolizumab and pembrolizumab plus berahyaluronidase alfa-pmph in combination with sacituzumab govitecan-hziy for first-line treatment of mTNBC.

Approach:

Trial Design: The approval was based on the phase 3 KEYNOTE-D19/ASCENT-04 trial involving 443 patients with PD-L1-positive unresectable locally advanced or mTNBC.
Treatment Comparison: Patients were assigned to receive either pembrolizumab plus sacituzumab govitecan-hziy or pembrolizumab plus investigator's choice of chemotherapy.

Key Findings:

Pembrolizumab plus sacituzumab govitecan-hziy reduced the risk of disease progression or death by 35% compared to pembrolizumab plus chemotherapy.
Median progression-free survival was 11.2 months for the combination therapy versus 7.8 months for chemotherapy.
The objective response rate was 61% for the combination therapy and 55% for chemotherapy.

Interpretation:

Limitations:

Common adverse reactions included decreased blood cell counts, diarrhea, nausea, fatigue, and others.
Serious adverse reactions occurred in 38% of patients, with 3.2% resulting in fatalities.