Merck announces data from trial studying KEYTRUDA plus Trodelvy

Merck (MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA plus Trodelvy reduced the risk of disease progression or death by 35% versus KEYTRUDA plus chemotherapy for the first-line treatment of patients with PD-L1+ inoperable 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. These data from the pivotal Phase 3 ASCENT-04/KEYNOTE-D19 study will be presented today as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and were selected for the official ASCO Press Program. A higher objective response rate was observed for the KEYTRUDA plus Trodelvy combination, including 13% and 8% with a complete response, respectively, in the KEYTRUDA plus Trodelvy and KEYTRUDA plus chemotherapy arms. Notably, a substantially longer duration of response was observed with KEYTRUDA plus Trodelvy. Encouraging trends in overall survival were also observed, but data are immature at the time of PFS primary analysis. Overall survival follow-up remains ongoing and will continue to be monitored as a key secondary endpoint.