Why Is HIV Drug Giant Gilead Stock Falling Monday?

Gilead Sciences Inc GILD said its 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. 

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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 the 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 the last prior anti-PD-(L)1 therapy. Gilead intends to explore potential pathways to further understand SG’s role in these patients. Gilead plans to discuss the results from this trial with regulators.

Trodelvy is the first approved Trop-2-directed antibody-drug conjugate that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers and improved clinical outcomes for certain people with 2L metastatic urothelial cancer.

Price Action: GILD shares are down 7.60% at $80.66 during the premarket session on the last check Monday.

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