Gilead Sciences, Inc. announced that the Phase 3 EVOKE-01 study, which evaluated Trodelvy® (sacituzumab govitecan-hziy; SG) against docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) that had previously progressed following platinum-based and checkpoint inhibitor therapy, did not meet its primary endpoint of overall survival (OS).
While the study did not achieve its primary goal, a numerical OS improvement with Trodelvy was observed, including within both squamous and non-squamous histology patient groups. Trodelvy was generally well tolerated, with safety profiles consistent with prior studies and no new safety signals were identified.
Notably, pre-specified analysis of a sub-group of over 60% of patients non-responsive to last prior anti-PD-(L)1 therapy showed a more than three-month median OS difference favoring Trodelvy. This finding was not formally statistically tested due to lack of alpha control. Conversely, this difference was not exhibited in the sub-group of patients who did respond to their last anti-PD-(L)1 therapy.
Given the high unmet medical need, Gilead intends to further investigate the potential role of Trodelvy for these particular patients and will discuss the trial results with regulators.
Merdad Parsey, MD, PhD, Chief Medical Officer of Gilead Sciences, expressed continued confidence in Trodelvy’s potential for metastatic NSCLC and mentioned the company’s extensive lung cancer clinical development program, including multiple ongoing Phase 3 trials.
Gilead highlighted the ongoing Phase 3 EVOKE-03 study of Trodelvy in combination with pembrolizumab for 1L metastatic PD-L1 high NSCLC, bolstered by promising preliminary data from the Phase 2 EVOKE-02 study presented at the World Conference on Lung Cancer 2023.
Gilead’s broad clinical development program also includes research into domvanalimab, the first Fc-silent investigational anti-TIGIT antibody. Despite available immunotherapies, many patients with metastatic NSCLC will experience cancer progression, with limited options post-progression, especially for those unresponsive to immunotherapy.
Gilead thanked the participating patients, families, investigators, and advocates for their contributions to this research. Trodelvy, as a Trop-2-directed antibody-drug conjugate (ADC), has already shown survival benefits in two different cancer types and continues to be a subject of extensive research.