Merck, Gilead Halt Phase 3 Lung Cancer Trial After 620-Patient Study Misses PFS Goal
Updated
Updated · Merck · Jun 9
Merck, Gilead Halt Phase 3 Lung Cancer Trial After 620-Patient Study Misses PFS Goal
3 articles · Updated · Merck · Jun 9
Summary
Merck and Gilead discontinued the Phase 3 KEYNOTE-D46/EVOKE-03 trial testing Trodelvy plus Keytruda against Keytruda alone in previously untreated metastatic NSCLC patients with PD-L1 TPS of 50% or higher.
An external data monitoring committee recommended stopping the study after final progression-free survival and interim overall survival analyses showed only a numerical PFS improvement, with no statistical significance and little chance OS would turn significant.
About 620 patients were enrolled globally in the open-label, randomized study, and the companies said the combination’s safety profile matched the known risks of each drug, with no new safety signals.
Regulators have been informed, investigators will be notified, and patients were told to consult their physicians; Merck and Gilead said ongoing Trodelvy and Merck studies are unchanged.
The setback hits an effort to expand Trodelvy into first-line metastatic lung cancer, where NSCLC makes up 80% to 85% of lung cancers and 5-year survival for metastatic disease remains below 10%.