Prodotti competitors / Area Oncology
Regeneron halts advancement of fianlimab + cemiplimab in 1L NSCLC following Phase 2 assessment
On 29 April 2026, Regeneron Pharmaceuticals reported its first‑quarter 2026 financial and operating results, providing an update on its oncology development pipeline. As part of the business update, the company announced that it will not advance the Phase 2/3 program evaluating fianlimab (anti‑LAG‑3) in combination with cemiplimab (anti‑PD‑1) in first‑line (1L) metastatic non‑small cell lung cancer (NSCLC) into a Phase 3 study. According to Regeneron, the available Phase 2 data “do not support advancing to Phase 3”.
Regeneron currently has two Phase 2/3 studies ongoing in 1L NSCLC with fianlimab plus cemiplimab, for which no efficacy data readout has yet been disclosed. These include a study in patients with PD‑L1 ≥ 50% metastatic NSCLC comparing fianlimab + cemiplimab versus cemiplimab monotherapy (NCT05785767), and a study in non‑squamous or squamous, PD‑L1 all‑comer metastatic NSCLC comparing fianlimab + cemiplimab versus cemiplimab plus chemotherapy (NCT05800015).
The decision represents the second recent discontinuation of a LAG‑3‑based combination strategy in the 1L NSCLC setting, following the termination of the Phase 3 TACTI‑004 trial of eftilagimod alfa plus pembrolizumab and chemotherapy after an Independent Data Monitoring Committee recommendation based on a planned interim futility analysis. At present, one LAG‑3 program remains in late‑stage development in this setting: Bristol Myers Squibb’s Phase 3 RELATIVITY‑1093 study evaluating relatlimab plus nivolumab and chemotherapy versus pembrolizumab plus chemotherapy in 1L non‑squamous NSCLC with PD‑L1 expression 1–49%.
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