Sanofi, Regeneron plan submitting for Libtayo

Sanofi and Regeneron plan to submit this year their product Libtayo, which has shown in a pivotal trial with certain patients with advanced basal cell carcinoma, that it has meaningful and durable responses.

Topline data were announced Tuesday, for a pivotal, single-arm, open-label trial for Sanofi and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to prior hedgehog pathway inhibitor (HHI) therapy were announced today. Libtayo demonstrated clinically meaningful and durable responses in this group of patients for whom there are no approved treatments, Sanofi and Regeneron said in the press release.

“While PD-1 inhibitors have transformed the outlook for many patients with melanoma, progress for patients with non-melanoma skin cancers has not been as rapid,” said Peter C. Adamson, M.D, Global Head of Oncology Development at Sanofi. 

Adamson said that Libtayo has appeared in this second trial, as a potential therapy for patients with advanced basal cell carcinoma. “These important new results further demonstrate Libtayo’s potential in patients with difficult-to-treat, non-melanoma skin cancers.”

There were no new safety signals in this trial, according to the press release. Furthermore, among the 132 patients assessed for safety (84 locally advanced and 48 metastatic), 95% of patients experienced an adverse event (AE), 32% had a serious AE and 13% discontinued due to an AE. There were 10 deaths in the locally advanced group and nine deaths in the metastatic group; none of the deaths were considered treatment-related, Sanofi and Regeneron said, adding will present additional trial findings at an upcoming medical meeting.

“Libtayo is being investigated as a monotherapy treatment and as a foundation therapy for combinations with novel therapeutic approaches being developed by Regeneron and our collaborators,” Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “These data in advanced BCC provide the third instance where Libtayo monotherapy has demonstrated robust and clinically meaningful outcomes in advanced cancer, and follows last week’s announcement in advanced non-small cell lung cancer where the pivotal trial was stopped early for positive overall survival.”

In this ongoing global Phase 2 trial, patients received Libtayo 350 mg intravenously every three weeks for up to 93 weeks or until disease progression, unacceptable toxicity, withdrawal of consent or confirmed complete response. ORR is the primary endpoint and key secondary endpoints include overall survival, progression-free survival, duration of response, safety and quality of life.