Merck's KEYTRUDA Combo Cuts Risk By 35% In First-Line PD-L1+ Metastatic TNBC, Phase 3 Study Confirms

(RTTNews) - Merck & Co Inc. (MRK) announced that KEYTRUDA (pembrolizumab) plus Trodelvy (sacituzumab govitecan-hziy) reduced the risk of disease progression or death by 35% compared to KEYTRUDA plus chemotherapy for the first-line treatment of patients with PD-L1+ (Combined Positive Score [CPS] =10) inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (TNBC), as determined by an FDA-approved test.

KEYTRUDA, when given in combination with Gilead's TROP2 antibody-drug conjugate (ADC) Trodelvy, resulted in a median progression-free survival (PFS) of 11.2 months versus 7.8 months when KEYTRUDA was given in combination with chemotherapy.

The safety profile of KEYTRUDA plus Trodelvy in this study was consistent with the known safety profile of each agent. No new safety signals were identified with the combination.

The data from the pivotal Phase 3 ASCENT-04/KEYNOTE-D19 study will be presented today as a late-breaking oral presentation.

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