Regeneron said today it has halted codevelopment with Bayer of a therapy combining the companies’ marketed treatment Eylea® (aflibercept) and Regeneron’s nesvacumab—an up-to-$130 million-plus collaboration launched last year—following the combination’s failure in a pair of Phase II trials in eye disorders.
The combination “did not provide sufficient differentiation to warrant Phase III development” compared with Eylea alone in the two trials, Regeneron stated. The Eylea–nesvacumab combination was assessed in the RUBY trial (NCT02712008), which evaluated patients with diabetic macular edema (DME), as well as the ONYX study (NCT02713204), which evaluated the combo in patients with wet age-related macular degeneration (wet AMD).
Eylea results were consistent with findings in previous clinical studies, according to Regeneron, which added that results from RUBY and ONYX will be further analyzed and submitted for presentation at an unspecified future medical congress.
RUBY enrolled 304 patients and ONYX enrolled 265. The studies evaluated two different doses of nesvacumab in combination with Eylea, both administered as a single coformulated intravitreal injection, as well as aflibercept monotherapy. The primary endpoint for both trials was change in best-corrected visual acuity (BCVA) between weeks 12 and 36 as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
“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,” Regeneron president and CSO George D. Yancopoulos, M.D., Ph.D., said in a company statement.
Development of Eye Disease Combination Therapy Halted by Regeneron, Bayer after Phase II Failures