Gilead announces data on Trodelvy plus Keytruda
Gilead (GILD) Sciences announced Trodelvy plus Keytruda reduced the risk of disease progression or death by 35% versus standard of care Keytruda plus chemotherapy in first-line treatment for patients with PD-L1+ metastatic triple-negative breast cancer, TNBC. Trodelvy when given in combination with Keytruda resulted in a median progression-free survival of 11.2 months vs 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 ASCO Annual Congress. For the primary endpoint, the median PFS was 11.2 months with Trodelvy plus Keytruda compared to 7.8 months with Keytruda plus chemotherapy, with a median follow-up of 14 months. A highly statistically significant and clinically meaningful improvement was observed with Trodelvy plus Keytruda, showing a 35% reduction in the risk of disease progression or death in the intent to treat population compared to standard of care Keytruda plus chemotherapy combination. The PFS benefit was generally consistent across key prespecified subgroups. A numerically higher overall response rate was observed for the Trodelvy plus Keytruda combination including 13% and 8% with a complete response, respectively, in the Trodelvy plus Keytruda and Keytruda plus chemotherapy arms. Notably, a substantially longer duration of response was observed with Trodelvy plus Keytruda.
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