Top-line results from a pivotal Phase II study showed that Sanofi and Regeneron Pharmaceuticals' Libtayo (cemiplimab) demonstrated clinically meaningful and durable responses in patients with advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to prior hedgehog pathway inhibitor therapy, the companies announced Tuesday. The drugmakers said they plan regulatory applications for the PD-1 inhibitor in this indication, for which there are currently no approved treatments, later this year.
Results of the trial showed that for the primary endpoint, the objective response rate (ORR) for 84 patients with locally advanced disease was 29%, with an estimated duration of response (DOR) exceeding one year in 85% of responders. Meanwhile, the durable disease control rate (DCR) was 60%. Sanofi and Regeneron added that in a preliminary analysis of 28 patients with metastatic disease, the ORR was 21%, with an estimated DOR exceeding one year in 83% of responders and a durable DCR of 46%.
The companies noted that among 132 patients assessed for safety in the study, 95% experienced an adverse event (AE), 32% had a serious AE and 13% discontinued due to an AE. Although there were 10 deaths in the locally advanced group and nine deaths in the metastatic group, none were considered treatment-related. Regeneron and Sanofi said that they plan to will present further data from the study at an upcoming medical meeting.
"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," remarked Israel Lowy, Regeneron's senior vice president of translational and clinical sciences for oncology.
Libtayo is approved in the US, EU and other countries for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The fully-human monoclonal is also being investigated in adjuvant and neoadjuvant CSCC, as well as potentially registrational Phase III trials in non-small-lung cancer and cervical cancer.
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