Merck and Gilead stop Phase 3 KEYNOTE-D46/EVOKE-03 lung cancer study

Merck and Gilead said an independent Data Monitoring Committee recommended stopping the Phase 3 trial of Trodelvy plus Keytruda in previously untreated PD-L1-high non-small cell lung cancer. Progression-free survival improved numerically but not significantly, and overall survival is unlikely to reach significance at the final analysis. Ongoing Trodelvy studies are unchanged.

• Trial compared Trodelvy plus Keytruda with Keytruda alone in about 620 patients
• PFS improved numerically but did not reach statistical significance
• Overall survival significance judged unlikely at the planned final analysis
• No new safety signals; other Trodelvy and Merck studies continue unchanged