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Novartis’ RTH258 for wet AMD meets endpoints in phase 3 trials
RTH258 for wet age-related macular degeneration, met its primary and key secondary endpoints in two phase 3 studies, according to a Novartis press release.
The HAWK and HARRIER trials studied the non-inferiority of RTH258 (brolucizumab, 6 mg) vs. Eylea (aflibercept, Regeneron) in regards to change in best corrected visual acuity from baseline to week 48 and average mean change between week 36 and week 48. These endpoints were met with significant P values.
The 96-week prospective, randomized, double-masked trials enrolled more than 1,800 patients in 400 worldwide centers.
RTH258, a single-chain antibody fragment VEGF inhibitor, also showed long-lasting efficacy dosed every 8 weeks compared with aflibercept, and a majority of the patients were maintained in a 12-week interval through week 48 after the loading phase, according to the release.
“These results clearly and convincingly demonstrate RTH258 has the potential to reduce injection burden while providing excellent visual outcomes,” Vas Narasimhan, Novartis global head of drug development and chief medical officer, said in the release.
The company plans to begin working with regulatory agencies based on the trial data, Narasimhan said in the release.
Perspective
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The two phase 3 pivotal studies — HAWK and HARRIER — evaluating brolucizumab for the treatment of neovascular AMD demonstrated positive outcomes for both the low- and high-dose brolucizumab groups at 12-week treatment intervals (for most patients) as compared with aflibercept 2 mg dosed every 2 months. This result, evaluated in more than 1,800 patients across both studies, will be extremely encouraging for our patients who currently receive anti-VEGF treatments approximately 6 times per year — the ability to dose only three or four times a year after the initialing loading sequence will be a welcome development for our patients with this chronic disease. We will need to wait until the full data set is available in order to appreciate the precise magnitude of the visual acuity benefit and also to determine the visual acuity outcomes in patients who received rescue therapy more often than those who did not. Similarly, it will be interesting to compare the change in visual acuity over time in the brolucizumab cohort vs. the aflibercept bimonthly arm. Of course, this is not a perfect comparison insofar as many patients current receiving aflibercept therapy for neovascular AMD are treated more frequently than every 8 weeks and those more frequently treated aflibercept patients may have different visual acuity outcomes than those treated on a strict every 8-week regimen as was done in these studies. Just more than half of patients in each brolucizumab cohort received no additional therapy, so it is not the case that all patients in the brolucizumab arms were treated only every 12 weeks. Nevertheless, this is certainly an exciting development, and we look forward to being able to evaluate the full data set soon.