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

Document Type

Conference Proceeding

Publication Date

9-1-2023

Publication Title

J Am Acad Dermatol

Keywords

cemiplimab, endogenous compound, fianlimab, lymphocyte activation gene 3 protein, programmed death 1 ligand 1, programmed death 1 receptor, advanced cancer, aged, cancer combination chemotherapy, cancer patient, cancer survival, cohort analysis, conference abstract, controlled study, drug combination, drug efficacy, drug safety, drug therapy, female, human, intravenous drug administration, Kaplan Meier method, lymphocyte activation, major clinical study, male, melanoma, monotherapy, overall response rate, phase 1 clinical trial, progression free survival, remission, treatment duration

Abstract

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.

Medical Subject Headings

Hematology

PubMed ID

Not assigned.

Volume

89

Issue

3

First Page

AB207

Find It @ Sladen

Share

COinS