Roche Releases Phase 2 Data for Novel Drug as Anti-VEGF Biosimilars Advance

February 14, 2018
The Center for Biosimilars Staff

Roche has released positive phase 2 data for its proposed novel anti–vascular endothelial growth factor and anti–angiopoietin-2 bispecific antibody, RG7716.

Roche has released positive phase 2 data for its proposed novel anti—vascular endothelial growth factor (anti-VEGF) and anti–angiopoietin-2 bispecific antibody, RG7716. The proposed drug, says Roche, is the first bispecific antibody designed specifically for the treatment of retinal eye diseases. The data show that RG7716 resulted in clinically meaningful, statistically significant improvements in visual acuity gains compared to Roche’s ranibizumab (Lucentis) alone.

The phase 2 BOULEVARD trial—a prospective, randomized, comparator-controlled, double-masked, multicenter, 3-arm study, assessed 2 doses of RG7716, 1.5 mg and 6 mg (given monthly for 20 weeks), versus ranibizumab, in 229 patients with diabetic macular edema.

The study met its primary endpoint: demonstrating a significant improvement in adjusted Best Corrected Visual Acuity at week 24 for RG7716 versus ranibizumab in treatment-naïve patients. The 6-mg dose of the investigational drug resulted in an adjusted mean improvement of 13.9 chart letters from baseline, compared with 10.3 letters in patients treated with 0.3 mg of ranibizumab. RG7716 was also well tolerated, with no new safety signals observed. The data were presented at Angiogenesis, Exudation, and Degeneration 2018, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine.

Despite these results, some analysts see little reason for excitement about the proposed novel drug; Fierce Pharma reports that analyst Geoffrey Porges of Leerink Partners told clients that the trial results were “somewhat lackluster,” and that RG7716 and brolucizumab—an anti-VEGF that Novartis said in 2017 had met its primary phase 3 endpoint of non-inferiority versus Regeneron’s aflibercept (Eylea) in patients with neovascular age-related macular degeneration—had no “clear advantages” over existing anti-VEGF options.

However, those existing drugs face encroaching biosimilar competition. In January 2018, Momenta and Mylan announced that they will begin a pivotal clinical trial of M710, a proposed aflibercept biosimilar, and German drug maker Formycon reports that it is in preclinical development with its own aflibercept molecule, FYB203. Ranibizumab, meanwhile, faces challenges from Formycon’s FYB201 and Samsung Bioepis’ SB11, both of which are in phase 3 development. Finally, the off-label use of Avastin (bevacizumab), an anti-VEGF approved for cancer indications only, has been steadily increasing in the treatment of eye diseases, and the upcoming launch of a biosimilar bevacizumab (the FDA-approved Mvasi), is likely to perpetuate this trend.