Phase 3 study of Trodelvy for advanced lung cancer misses primary endpoint
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A randomized phase 3 study designed to assess sacituzumab govitecan-hziy for treatment of previously treated metastatic non-small cell lung cancer failed to meet its primary endpoint of OS, according to the agent’s manufacturer.
Sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) is a Trop-2-directed antibody-drug conjugate. The agent is approved for treatment of certain patients with breast cancer or urothelial cancer.
The EVOKE-01 study included 603 patients with metastatic or advanced NSCLC that progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy.
Researchers assigned patients to sacituzumab govitecan-hziy or docetaxel.
OS served as the primary endpoint. Key secondary endpoints included PFS, objective response rate, duration of response and disease control rate.
Results showed a numerical improvement in OS with sacituzumab govitecan-hziy for patients with squamous or nonsquamous histologies; however, the difference did not reach statistical significance.
Results showed improved median OS with sacituzumab govitecan-hziy among patients who did not respond to last prior anti-PD-1/anti-PD-L1 therapy, and further analyses will be conducted to better understand the role the agent may have for this population, according to a Gilead press release.
Sacituzumab govitecan-hziy exhibited a safety profile consistent with prior studies. Investigators observed no new safety signals.
Complete data from the study will be presented at a medical meeting.
“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,” Merdad Parsey, MD, PhD, chief medical officer for Gilead Sciences, said in the release. “We will work to further identify the metastatic NSCLC patient populations that may benefit from Trodelvy.”
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