43001 Phase 1 study of fianlimab, a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced melanoma: Expansion cohort analysis

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Conference Proceeding

Publication Date


Publication Title

J Am Acad Dermatol


Background: Concurrent blockade of LAG-3 may enhance efficacy of anti-programmed cell death-1 (PD-1) therapies. We present updated safety and efficacy data from the Phase 1 study in patients with advanced melanoma treated with anti–LAG-3 (fianlimab) 1600 mg + anti–PD-1 (cemiplimab) 350 mg intravenously every 3 weeks for 12 months. Methods: We included patients with advanced melanoma who were anti–PD-1/PD-L1-naive (expansion cohorts [EC] 6 and 15; enrolled sequentially) or anti–PD-1/PD-L1-experienced within 3 months of screening (EC7). Results: As of July 1, 2022, data cutoff date, 80 patients in EC6+EC15 (40 each) and 15 in EC7 received fianlimab + cemiplimab. For EC6+EC15 and EC7 respectively, median age was 69.0 and 59.0 years, 60.0% and 46.7% were male, and 90.0% and 60.0% were White. Median treatment duration was 30.9 weeks (EC6+EC15) and 9.0 weeks (EC7). Grade 2:3 treatment-emergent adverse events (TEAEs) occurred in 40.0% (EC6+EC15) and 46.7% (EC7) of patients. Serious TEAEs occurred in 28.8% (EC6+EC15) and 33.3% (EC7) of patients. The investigator-assessed ORR was 63.8% (7 complete responses; 44 partial responses) in EC6+EC15 and 13.3% in EC7. Kaplan-Meier estimation of median progression free survival was 24.0 months (95% confidence interval [CI]: 9.9–not evaluable) in EC6+EC15 and 1.5 months (95% CI: 1.3–7.7) in EC7. Median duration of response has not been reached in these cohorts. Conclusion: Fianlimab + cemiplimab demonstrated high clinical activity among patients with anti–PD-1/PD-L1-naive advanced melanoma across sequential ECs with a similar safety profile to cemiplimab monotherapy.

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