Phase 1 study of fianlimab (FIAN), a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, plus cemiplimab (CEMI) in advanced melanoma (mel)
Recommended Citation
Hamid O, Weise A, Kim T, McKean M, Lakhani NJ, Kaczmar J, Papadopoulos KP, Chen S, Mani J, Jankovic V, Kroog G, Sims T, Lowy I, Gullo G. Phase 1 study of fianlimab (FIAN), a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, plus cemiplimab (CEMI) in advanced melanoma (mel). 2022; (1):126.
Document Type
Conference Proceeding
Publication Date
12-29-2022
Abstract
Concurrent LAG-3 blockade may enhance efficacy of anti-programmed cell death-1 (PD-1) therapies such as CEMI. We present updated safety and clinical activity data from patients (pts) with advanced mel treated concurrently with CEMI and FIAN (NCT03005782). Pts were included with unresectable or metastatic mel (excluding uveal mel) who were anti-PD- ligand (L) 1 treatment naive (expansion cohort [EC] 6) or anti-PD- ( L)1 experienced within 3 mo of screening (EC7). Pts received FIAN 1600 mg + CEMI 350 mg intravenously every 3 wks for 12 mo (optional extra 12 mo if clinically indicated). Tumours were measured every 6 wks for 24 wks, then every 9 wks. In EC6 (n = 40) and EC7 (n = 15), respectively (data cutoff 9 Feb 2022), median age was 69.5 and 59.0 years, 63% and 47% were male, 90% and 60% were White, and median treatment duration was 37.1 wks and 9.0 wks. In EC6 and EC7, respectively, incidence of Grade ≥3 treatment-emergent adverse events (TEAEs) was 38% and 47%, incidence of serious TEAEs was 33% and 33%, and 18% and 13% of pts discontinued treatment due to a TEAE. Adrenal insufficiency rate was 13% and 7% in EC6 and EC7, respectively; no instances led to treatment discontinuation. Investigator-assessed objective response rate was 63% (6 complete responses; 19 partial responses [PRs]) in EC6 and 13% (2 PRs) in EC7. Kaplan-Meier estimate of median progression-free survival was 14.2 (95% CI: 5.6-not estimated) mo in EC6 and 1.4 (95% CI: 1.3-7.7) mo in EC7. Median duration of response was not reached in EC6 or EC7. FIAN + CEMI in advanced mel had a similar safety profile to anti-PD- 1 monotherapies. Clinical activity in anti-PD- ( L)1-naive pts appeared higher than previously reported for anti-PD- 1 monotherapy or anti-LAG- 3 + anti-PD- 1. A Phase 3 trial (NCT05352672) investigating FIAN + CEMI in advanced mel is ongoing.
Issue
1
First Page
126
