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.

Conclusion:

Sources:

• Merck Press Release