2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.86 (Poster) Phase 1 Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced NSCLC

PP01.86 (Poster) Phase 1 Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced NSCLC

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A Phase 1 study was conducted to evaluate the safety and efficacy of the combination therapy of Fianlimab, a monoclonal antibody that blocks lymphocyte activation gene-3 (LAG-3), and cemiplimab, an anti-programmed cell death protein 1 (PD-1) antibody, in patients with advanced non-small cell lung cancer (NSCLC). The study included two expansion cohorts, one comprising anti-PD-1/PD-L1 treatment-naïve patients and the other comprising anti-PD-1/PD-L1 treatment-experienced patients.<br /><br />Preliminary data from the study showed that the combination therapy had an acceptable safety profile and displayed signs of activity in patients with advanced NSCLC. Deep and durable objective responses were observed in patients with PD-L1 expression ≥50%. The study also showed that the combination therapy demonstrated promising clinical activity in patients with anti-PD-1/PD-L1 naïve NSCLC, particularly in those with PD-L1 expression ≥50%.<br /><br />The safety profile of the combination therapy appeared to be similar to that of cemiplimab monotherapy, with no new safety signals identified except for a higher rate of adrenal insufficiency. Grade 3 treatment-emergent adverse events occurred in a percentage of patients in both expansion cohorts, and serious treatment-emergent adverse events were reported in a smaller percentage of patients.<br /><br />The study also assessed the pharmacokinetics of Fianlimab and found that the serum concentrations of the drug were similar across the two expansion cohorts. Biomarker assessment showed that patients with LAG-3 expression ≥1% had an objective response rate of 42.9% in expansion cohort 1, while all patients with PD-L1 expression ≥50% in expansion cohort 1 had an objective response rate of 100%.<br /><br />Based on these findings, further clinical trials are being carried out to assess the combination therapy of Fianlimab and cemiplimab in advanced NSCLC. Phase 2/3 trials are ongoing in patients with tumors expressing PD-L1 ≥50% and in patients irrespective of PD-L1 expression levels.

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Byoung Chul Cho

Keywords

Phase 1 study

combination therapy

Fianlimab

LAG-3

cemiplimab

NSCLC

objective responses

adrenal insufficiency

clinical trials

PD-L1 expression