Gilead and Merck said they will stop a Phase 3 trial of Trodelvy (sacituzumab govitecan) plus Keytruda in first-line PD-L1-high non-small cell lung cancer after an external data monitoring committee recommended discontinuation. The companies said the study failed to meet its progression-free survival endpoint at final analysis, and overall survival appeared unlikely to reach statistical significance. The Evoke-03 decision compounds prior setbacks for Trodelvy, tightening commercial expectations in NSCLC. Analysts are expected to shift attention to Trodelvy’s development and use cases in other tumor types, particularly where the risk-reward profile can still support its high acquisition price. The trial outcome also reframes competitive assumptions for how easily next-generation TROP2 ADC regimens can beat Keytruda monotherapy as an entry strategy in first-line lung cancer.
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