Gilead and Merck shut down the phase 3 Evoke-03 trial after interim analyses indicated Trodelvy plus Keytruda was unlikely to meet the progression-free survival endpoint in first-line PD-L1-high non-small cell lung cancer. The external data monitoring committee recommendation triggered the early stop. While the companies reported a positive trend in PFS, an interim look at overall survival suggested the trial was unlikely to achieve statistical significance. The setback adds to a tense competitive landscape for TROP2 antibody-drug conjugates, where durability and head-to-head positioning against Keytruda monotherapy remain major hurdles. Analysts highlighted the commercial and strategic implication: Trodelvy’s future in first-line lung cancer now hinges on a more constrained label footprint, while the broader field watches Merck’s next-in-class rival ADC strategies in the same setting.
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