Regeneron scraps Eylea combination after phase 2 setbacks

The combination “did not provide sufficient differentiation to warrant phase 3 development.”

Regeneron has halted development of an ophthalmic combination of nesvacumab and Eylea. The decision follows data from two phase 2 trials that tested angiopoietin 2 antibody nesvacumab in combination with Eylea.

Tarrytown, New York-based Regeneron is yet to post data from the trials, saying only that the addition of nesvacumab to its blockbuster Eylea “did not provide sufficient differentiation to warrant phase 3 development.” That decision was based on the results of trials that assessed the efficacy of the combination in 300 patients with diabetic macular edema and a similar number of people with neovascular age-related macular degeneration.

Regeneron and partner Bayer, which paid $50 million to buy into the drug last year, were looking to nesvacumab to shore up their Eylea franchise in the face of intensifying competition. Most notably, Novartis is planning to hit back against Eylea—which challenged its Lucentis—with the long-acting VEGF inhibitor brolucizumab, also known as RTH258. Phase 3 data suggest brolucizumab matches or beats the efficacy of Eylea and has a less burdensome dosing schedule.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

The failure of nesvacumab in phase 2 means two of Regeneron’s attempts to improve on Eylea have fallen short. The first setback came 14 months ago, when Regeneron reported the failure of anti-PDGFR-beta antibody rinucumab to improve on Eylea. In between the two setbacks, Novartis and its partner Ophthotech reported on the failure of their anti-PDGF drug to move the needle in phase 3.

RELATED: Novartis' longer-acting AMD drug matches archrival Eylea in phase 3 trials

Novartis’ fortunes improved with brolucizumab, magnifying the potential impact of the failures of nesvacumab and rinucumab on Regeneron and its critical Eylea franchise. Regeneron is working on a long-acting formulation of Eylea that could compete with brolucizumab. But, even accounting for the manufacturing-related holdup of Novartis’ filing for approval of brolucizumab, Regeneron risks ceding a head start to its competitor. 

The nesvacumab and rinucumab clinical trials are potentially-costly blots on Regeneron’s generally-enviable R&D record. Regeneron CSO George Yancopoulos, M.D., Ph.D., framed the rare back-to-back setback as a result of the success of Eylea.

"We knew from the start that it would be difficult to improve on the already high bar set by Eylea,” Yancopoulos said in a statement. 

Suggested Articles

The Rady Children’s Institute for Genomic Medicine tapped Deloitte to help develop a network of flying drones to deliver genetic testing specimens.

Sumitovant CEO Myrtle Potter discusses the $3 billion Roivant-Sumitomo deal, her role at Sumitovant and what's up in 2020.

The FDA approved a new, tiny pacemaker from Medtronic that does not require the wiring of separate electrodes between the implant and the heart.