Gilead : Phase 3 EVOKE-01 study did not meet primary endpoint of OS in NSCLC

Gilead Sciences announced that the Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival OS in previously treated metastatic non-small cell lung cancer NSCLC. EVOKE-01 is evaluating Trodelvy, sacituzumab govitecan-hziy; SG, vs. docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. A numerical improvement in OS favoring SG was observed in the study, including in patients with both squamous and non-squamous histology. The safety profile for Trodelvy was consistent with prior studies. Trodelvy was generally well tolerated, and no new safety signals were identified in this patient population. A more than three-month difference in median OS favoring SG was observed in a sub-group of patients non-responsive to last prior anti-PD-(L 1 therapy, representing over 60% of the trial population. This analysis was pre-specified in the protocol, but not alpha-controlled for formal statistical testing. This magnitude of difference was not observed in the sub-group of patients with response to last prior anti-PD-L 1 therapy. Gilead intends to explore potential pathways to further understand the role SG may have in these patients given the high unmet medical need. Gilead plans to discuss results from this trial with regulators. The data will be presented at an upcoming medical meeting. “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Treating metastatic NSCLC that has progressed on or after platinum-based chemotherapy presents significant challenges and the need for safe and effective treatments remains urgent. We will work to further identify the metastatic NSCLC patient populations that may benefit from Trodelvy.”