Fianlimab/Cemiplimab Demonstrates Early Clinical Activity and Safety in Advanced Melanoma

Source: OncLive, June 2023

The LAG-3 inhibitor fianlimab plus cemiplimab (Libtayo) produced high and consistent tumor responses and a comparable toxicity profile to that of anti–PD-L1 monotherapies in patients with advanced melanoma who were PD-L1 inhibitor–naïve in the advanced setting, according to data from a phase 1 study (NCT03005782) presented at the 2023 ASCO Annual Meeting.

The phase 1 study (NCT03005782) enrolled 98 patients, 13.3% of whom had received PD-1/PD-L1 inhibitors as adjuvant or neoadjuvant therapy. The objective response rate (ORR) for fianlimab/cemiplimab was 61.2% in all patients, 60.9% in patients with any adjuvant treatment, and 61.5% in those who had received adjuvant PD-1 therapy.

“In the combination of fianlimab and cemiplimab, we showed a consistent and reproducible high clinical activity in independent cohorts of patients who were naive to anti–PD-1 in the advanced melanoma setting,” Omid Hamid, MD, chief of translational research and immunotherapy and director of melanoma therapeutics at The Angeles Clinic and Research Institute in Los Angeles, California, stated in his presentation. “Similar clinical activity was observed in patients treated with prior adjuvant therapies including anti–PD-1.”