Regeneron Pharmaceuticals REGN announced that the late-stage study evaluating the combination of fianlimab and cemiplimab in first-line unresectable locally advanced or metastatic melanoma failed to meet the primary endpoint of statistically significant improvement in progression-free survival (PFS) versus Merck’s MRK Keytruda (pembrolizumab) monotherapy.
Fianlimab is a LAG-3 inhibitor while cemiplimab is a PD-1 inhibitor.
The detailed results from the study will be presented at an upcoming medical meeting.
More on REGN’s Phase III Melanoma Study
The randomized, double-blind phase III study is evaluating fianlimab in combination with cemiplimab against pembrolizumab in treatment-naïve patients aged 12 years and older with unresectable locally advanced or metastatic melanoma.
A total of 1,546 patients were enrolled and randomized to receive either high-dose fianlimab (1,600 mg) plus cemiplimab (350 mg) every three weeks, low-dose fianlimab (400 mg) plus cemiplimab (350 mg) every three weeks, pembrolizumab monotherapy (200 mg every three weeks) with placebo, or cemiplimab monotherapy (350 mg every three weeks) with placebo.
Despite missing statistical significance, the high-dose fianlimab combination demonstrated a numerical improvement in median PFS of 11.5 months compared with 6.4 months for pembrolizumab alone, translating to a 5.1-month. No new safety concerns were identified for the combination therapy.
The results represent a setback for Regeneron’s efforts to strengthen its position in the competitive melanoma immunotherapy market, where established PD-1/LAG-3 combinations such as Bristol Myers Squibb BMY Opdualag have already gained traction.
Regeneron continues to advance the program through an ongoing phase III head-to-head trial comparing the high-dose fianlimab and cemiplimab combination directly against Opdualag in first-line advanced melanoma. Positive outcomes from that study could still support the long-term commercial opportunity for the regimen despite the current trial miss.
Keytruda is approved for several types of cancer and alone accounts for around 50% of MRK’s pharmaceutical sales. Merck is currently working on different strategies to drive the long-term growth of Keytruda.
BMY’s Opdualag is a combination of nivolumab and relatlimab. The drug is indicated for treating adults who have a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma) and children who are 12 years of age and older, who have melanoma that has spread or cannot be removed by surgery (advanced melanoma).
Sales of Opdualag have been robust as the drug continues to serve as a standard of care in first-line melanoma.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
REGN’s Efforts to Diversify Portfolio
Regeneron is also actively strengthening its oncology portfolio to further diversify its revenue base. The company’s oncology franchise recently gained momentum following the label expansion of Libtayo, helping offset headwinds in the ophthalmology segment.
Regeneron’s first-quarter performance was encouraging, with overall revenues rising despite continued decline in sales of its flagship product, Eylea. This performance underscores the resilience and breadth of the company’s diversified portfolio.
Regeneron’s shares have lost 9.6% so far this year compared with the industry’s decline of 1.6%.
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However, Eylea sales remain under pressure amid intensifying competition from Roche’s Vabysmo, which has seen strong and rapid uptake. Vabysmo was designed to inhibit both Ang-2 and VEGF-A pathways, offering a differentiated mechanism that has resonated with physicians.
REGN’s Zacks Rank
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This article originally published on Zacks Investment Research (zacks.com).