Eylea, nesvacumab combination trials will not continue

Regeneron announced phase 3 development of a combination of Eylea and the angiopoietin2 antibody nesvacumab is not warranted after two phase 2 trials failed to show sufficient differentiation, according to a company press release.

The RUBY study, which evaluated patients with diabetic macular edema, and the ONYX study, which evaluated patients with wet age-related macular degeneration, were both randomized, double-masked, active-controlled phase 2 studies that investigated if the combination of Eylea (aflibercept) and nesvacumab would have a benefit over Eylea alone. The combination did not show sufficient differentiation, and “Eylea results were consistent with findings in previous clinical studies.”

“We knew from the start that it would be difficult to improve on the already high bar set by Eylea, which is the market-leading branded therapy in its approved indications, providing significant improvements in vision and strong long-term outcomes in patients with wet AMD and DME,” George D. Yancopoulos, MD, PhD, Regeneron’s president and chief scientific officer, said in the release.

Further analysis of the two studies will be submitted for presentation at a future medical congress, the release said.