Positive data announced from multiple expansion cohorts of Ph 1 trial of fianlimab and Libtayo® (cemiplimab) in advanced melanoma

“After regulatory approvals of our PD-1 inhibitor Libtayo in two advanced non-melanoma skin cancers, we are expanding our efforts in dermato-oncology to address advanced melanoma,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “Combining LAG-3 and PD-1 inhibition has shown promise in advanced melanoma but achieving response rates above 50% has been challenging. In two independent dose expansion cohorts from a Phase 1 clinical trial of patients naïve to PD-1 or PD-L1 inhibitors, our LAG-3 inhibitor fianlimab combined with Libtayo demonstrated greater than 60% response rates. Notably, the safety profile for this combination appears in line with Libtayo monotherapy. A Phase 3 trial in first-line metastatic melanoma is currently enrolling patients, and we look forward to opening additional trials with this combination in the near future.”
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