Aflibercept combination therapy fails to meet primary endpoint

Topline results from an ongoing phase 2 study showed aflibercept co-formulated with rinucumab, an anti-platelet-derived growth factor receptor beta (anti-PDGFR-beta) antibody, provided no added visual benefits over aflibercept alone for wet AMD.

The phase 2, double-masked, randomized, controlled study has enrolled approximately 500 patients with wet AMD. Patients were randomized to receive fixed doses every 4 weeks of either aflibercept monotherapy 2 mg, aflibercept 2 mg/rinucumab 1 mg or aflibercept 2 mg/rinucumab 3 mg.

At 12 weeks, patients in both combination aflibercept/rinucumab groups showed a 5.8 letter improvement compared with a 7.5 letter improvement in the aflibercept alone group. Drug efficacy was consistent across all choroidal neovascularization subtypes. The combination group also showed no benefit anatomically, including reduction in retinal thickness or in resolution of subretinal hyper-reflective material.

Additionally, ocular adverse events such as conjunctival hemorrhage, eye irritation and eye pain were more common in the combination groups (23.5% and 20%) compared with aflibercept alone (16%).

Regeneron will continue to collect data on patients at 28 weeks and 52 weeks, according to the press release.

“We are committed to continuing to innovate for patients with serious vision-threatening diseases, and look forward to the results of our ongoing combination studies of aflibercept and nesvacumab, an anti-angiopoietin 2 antibody, for which the preclinical data is more supportive," said George D. Yancopoulos MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories.

Regeneron's shares were down 3.6% percent in early trading.