Phase 3 Study of Sacituzumab Govitecan in NSCLC Misses Primary End Point


The phase 3 EVOKE-01 trial of sacituzumab govitecan in non–small cell lung cancer missed its primary end point, showing a numerical but not significant improvement in overall survival.

Lung with cancer cells: © catalin -

Lung with cancer cells: © catalin -

The EVOKE-01 study (NCT05089734) investigating sacituzumab govitecan-hziy (Trodelvy) vs docetaxel for the treatment of previously treated metastatic non–small cell lung cancer (NSCLC) has missed its primary end point of overall survival (OS), according to Gilead Sciences.1

A numerical but not significant improvement in OS was observed with sacituzumab. In a sub-group of patients who did not respond to prior anti-PD-(L)1 agents, there was a difference of greater than 3 months in median OS favoring sacituzumab. This finding represented over 60% of the trial population; however, this analysis was not alpha-controlled for formal statistical testing. Further, this difference was not observed in patients who did respond to prior anti-PD-(L)1 therapy.

Sacituzumab was well-tolerated, and its safety profile was consistent with prior studies of the agent. No new safety signals were identified.

“The totality of our data gives us continued confidence in [sacituzumab’s] potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences, in a press release. “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 [sacituzumab].”

Gilead anticipates a review with regulators about the findings of the EVOKE-01 trial. The complete data will be presented at an upcoming medical meeting.

About EVOKE-01

EVOKE-01 is a phase 3, global, multicenter, open-label, randomized study of sacituzumab vs docetaxel in patients with advanced or metastatic NSCLC who have experienced disease progression following platinum-based chemotherapy and anti-PD(L)1 therapy.2 Patients with EGFR, ALK, or other known actionable genomic alterations must have also received treatment with an available tyrosine kinase inhibitor appropriate to that alteration to be eligible for the study. The estimated enrollment of the study was 580 patients who have an ECOG performance status of 0 or 1, adequate hematologic counts, and adequate hepatic function.

Patients were not eligible for study enrollment if they had mixed small cell and NSCLC histology, not recovered from adverse events (AEs) from prior therapies, an active second malignancy, clinically severe pulmonary compromise, active cardiac disease, active serious infection, known central nervous system metastases, or active chronic inflammatory bowel disease.

The primary end point is OS. Secondary end points include progression-free survival, objective response rate, duration of response, disease control rate, incidence of treatment-emergent AEs, and incidence of laboratory abnormalities.

Patients were randomized to receive sacituzumab 10 mg/kg on days 1 and 8 of a 21-day cycle or docetaxel 75 mg/m2 on day 1 of a 21-day cycle until progressive disease or unacceptable toxicity.

1. Gilead provides update on phase 3 EVOKE-01 study. News release. Gilead Sciences. January 22, 2024. Accessed January 22, 2024.
2. Study of sacituzumab govitecan (SG) versus docetaxel in participants with advanced or metastatic non–small cell lung cancer (NSCLC) (EVOKE-01). Updated December 7, 2023. Accessed January 22, 2024.
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