Fianlimab (anti-LAG-3) + cemiplimab (anti-PD-1) in patients (pts) with advanced melanoma (Mel): Subgroup analyses by blinded independent central review (BICR)

Document Type

Conference Proceeding

Publication Date

1-28-2026

Publication Title

Pigment Cell and Melanoma Research

Keywords

cemiplimab, fianlimab, lactate dehydrogenase, lymphocyte activation gene 3 protein, programmed death 1 ligand 1, adrenal insufficiency, adult, aged, conference abstract, controlled study, drug therapy, drug withdrawal, female, follow up, human, major clinical study, male, melanoma, side effect, special situation for pharmacovigilance, survival rate, therapy, treatment duration, very elderly

Abstract

Background: Treatment with fianlimab + cemiplimab resulted in a 61% ORR by investigator assessment and an acceptable risk-benefit profile in pts with advanced Mel. Here, we present an efficacy analysis by BICR in both the overall population and subgroups of pts with advanced Mel (neoadjuvant/adjuvant pretreated [NAP], elevated LDH, BRAF status, adrenal insufficiency [AI] and ctDNA status). Methods: Three independent expansion cohorts of pts who were anti-PD-( L)1 treatment-naïve for advanced Mel (NCT03005782) received fianlimab 1600 mg + cemiplimab 350 mg IV Q3W for ≤ 24 months (mos). Results: Overall, 98 pts were enrolled (median [med] age: 68 years). At data cutoff (31 Oct 2023), med follow-up was 23 mos and med treatment duration was 36 weeks (wks). Grade ≥ 3 TEAEs: 47%; serious TEAEs: 39%; immune-mediated AEs: 39% of pts. Of the 76 pts (78%) who discontinued treatment, 17 (22%) were due to TEAEs. Overall BICR-assessed med PFS (mPFS), med OS (mOS), CR rate and ORR were 24 mos (95% CI 12-NE), NR (95% CI 42-NE), 25% and 57% (95% CI 47-67), respectively. Estimated survival probability was 83% at 12 mos and 71% at 24 mos. A total of 31% and 4% of pts completed 1 and 2 years of treatment, respectively. In NAP pts who had received anti-PD-( L)1 treatment (n = 13), mPFS, CR rate and ORR were NR (95% CI 1-NE), 31% and 46% (95% CI 19-75), respectively. Similar mOS rates were seen in NAP pts (NR [95% CI 26-NE]) versus NAP-naïve pts (NR [95% CI 31-NE]). In NAP and NAP-naïve pts, mPFS was NR (95% CI 3-NE) and 24 mos (95% CI 12-NE), respectively. Pts with LDH >ULN (n = 31) had mPFS, mOS, CR rate and ORR of 14 mos (95% CI 4-NE), 42 mos (95% CI 23-NE), 13% and 55% (95% CI 36-73), respectively. In pts with BRAF mutations (n = 48), the mPFS, mOS, CR rate and ORR were NR (95% CI 39-69), NR (95% CI NE-NE), 31% and 54% (95% CI 46-70), respectively. In pts with any-grade drug-related AI (n = 12), the mPFS, mOS, CR rate and ORR were NR (95% CI 8-NE), NR (95% CI 21-NE), 58% and 92% (95% CI 62-100), respectively. The mOS and mPFS for pts with uncleared ctDNA was 20.8 mos and 2.6 mos, respectively. The mOS and mPFS were NR in pts who were ctDNA-negative at Wk 9. Additional subgroup data by PD-L1 and LAG-3 expression will be presented at the meeting. Conclusions: With longer follow-up, fianlimab + cemiplimab continued to demonstrate high clinical activity and a generally acceptable safety profile in subgroups of pts with advanced Mel. Efficacy rates were higher in the 12% of pts with AI versus the overall study population.

Volume

39

Issue

1

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