Fianlimab + cemiplimab for advanced melanoma

Previously, the combination of fianlimab (anti-LAG-3) and cemiplimab (anti-PD-1) demonstrated an overall response rate (ORR) of 61% in a cohort of anti-PD-1 naïve advanced melanoma patients. During ESMO 2024, Dr Meredith McKean (Sarah Cannon Research Institute, Memphis, TN, USA) presented updated results of this trial with 12 months of additional follow-up.

After a median follow up of 23 months, fianlimab + cemiplimab continued to show persistent high clinical activity with an ORR of 57%. This benefit was seen regardless of PD-L1 or LAG-3 status and irrespective of the presence of high-risk features. Interestingly, a quarter of patients in the study obtained a complete response and this percentage continues to increase over time. At the 24-month landmark, 49% of patients was event-free. The safety profile of the fianlimab and cemiplimab combination was generally consistent with the safety profile of cemiplimab monotherapy and other anti-PD-(L)1 agents, except for higher rates of treatment-related adrenal insufficiency (12% of patients; Grade ≥3 in 5%).

In conclusion, these updated results solidify earlier reports and support the further evaluation of the fianlimab–cemiplimab combination in this setting.