Drugs

Regeneron Melanoma Trial Misses Primary Endpoint

Regeneron Pharmaceuticals says its Phase 3 trial evaluating the experimental immunotherapy combination of fianlimab and cemiplimab in advanced melanoma failed to meet its primary endpoint of statistically significant improvement in progression-free survival compared with pembrolizumab (Merck’s Keytruda) monotherapy.

The study tested two dose levels of the LAG-3 inhibitor fianlimab combined with the PD-1 inhibitor cemiplimab as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. Although the trial did not achieve statistical significance, Regeneron reported that the high-dose combination produced a numerical improvement in median progression-free survival of 11.5 months compared with 6.4 months for patients receiving pembrolizumab alone.

The company notes that the high-dose regimen generated a hazard ratio of 0.845 with a p-value of 0.0627, narrowly missing conventional statistical significance thresholds. The lower-dose combination arm showed a median progression-free survival of 9.6 months and did not demonstrate a significant benefit over pembrolizumab.

No new safety signals were identified in the study, the company said.

The randomized, double-blind Phase III trial enrolled 1,546 patients aged 12 years and older with unresectable or metastatic melanoma who had not previously received systemic therapy for advanced disease, according to the company. Patients were randomized to receive either high-dose fianlimab plus cemiplimab, low-dose fianlimab plus cemiplimab, pembrolizumab monotherapy, or cemiplimab monotherapy.

Fianlimab is designed to target LAG-3, an immune checkpoint protein involved in suppressing T-cell activity, according to Regeneron. The drug is being developed as part of a growing class of dual immune checkpoint inhibitor regimens aimed at improving outcomes beyond PD-1 blockade alone.

Regeneron Pharmaceuticals said a separate Phase 3 head-to-head trial comparing the high-dose fianlimab combination against Opdualag remains ongoing in first-line unresectable or metastatic melanoma.

Detailed results from the failed study will be presented at a future medical meeting, the company said.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome