Merck gains FDA approval for Keytruda plus Trodelvy in first-line TNBC

• The FDA approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX in combination with Trodelvy for first-line treatment of PD-L1 positive (CPS ≥10) unresectable locally advanced or metastatic triple-negative breast cancer.
• The combination reduced the risk of disease progression or death by 35% versus KEYTRUDA plus chemotherapy in the KEYNOTE-D19/ASCENT-04 trial.
• This marks the first approval of a PD-1 inhibitor plus Trop-2-directed ADC regimen in the first-line advanced TNBC setting.

Merck (NYSE:MRK) announced that the U.S. Food and Drug Administration approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Trodelvy (sacituzumab govitecan-hziy), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (CPS ≥10).

The approvals represent the first PD-1 inhibitor plus Trop-2-directed antibody-drug conjugate regimen in this setting.

The decision was based on the Phase 3 KEYNOTE-D19/ASCENT-04 trial, which showed KEYTRUDA plus Trodelvy reduced the risk of disease progression or death by 35% (HR=0.65) versus KEYTRUDA plus chemotherapy.

Median progression-free survival was 11.2 months with the combination versus 7.8 months with KEYTRUDA plus chemotherapy.

The objective response rate was 61% versus 55%, with complete response rates of 12% and 8%, respectively.

This approval expands options for patients with PD-L1 positive advanced TNBC, a particularly aggressive form of breast cancer.