> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Gilead Trodelvy Trial Misses Endpoint
- URL: https://www.fdaweb.com/gilead-trodelvy-trial-misses-endpoint/
- Published: 2024-01-22T12:00:00.000Z
- Updated: 2026-09-14T14:20:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156183

Gilead Sciences says its Trodelvy (sacituzumab govitecan-hziy) Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival (OS) in previously treated patients with metastatic non-small cell lung cancer (NSCLC). The therapy is currently FDA approved for treating certain patients with breast cancer. EVOKE-01 had been evaluating Trodelvy) vs. docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

In announcing the disappointing results, Gilead did note that a numerical improvement in OS in the Trodelvy-treated patients was observed in the study, including in patients with both squamous and non-squamous histology. “A more than three-month difference in median OS favoring SG \[Trodelvy\] 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,” it says. “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 says it will further explore potential pathways to understand the role Trodelvy may have in these patients due to the high unmet medical need.