Gilead Sciences, Inc. (NASDAQ: GILD) shares began the day in a big hole, on word 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.
GILD shares withered $8.71, or 10%, to $78.58.