Results of the late-stage study demonstrated that crovalimab administered as a subcutaneous injection every four weeks, controlled the disease and was not inferior to eculizumab
Genentech said that crovalimab has met the co-primary efficacy endpoints of the phase 3 COMMODORE 2 study in patients with paroxysmal nocturnal hemoglobinuria (PNH).
The co-primary efficacy endpoints of the late-stage clinical trial are transfusion avoidance and control of hemolysis.
Crovalimab is an anti-C5 recycling monoclonal antibody. It is engineered to block the complement system, which is considered to be a very important part of the innate immune system.
Genentech evaluated the efficacy and safety of the drug candidate compared to the current standard of care, eculizumab, in patients who did not receive prior treatment with complement inhibitors.
The Roche subsidiary said that the results demonstrated that crovalimab administered as a subcutaneous injection every four weeks, controlled the disease and was not inferior to eculizumab.
Eculizumab is administered intravenously once every two weeks.
The efficacy and safety findings from the separate COMMODORE 1 phase 3 study in people with PNH switching from presently approved C5 inhibitors to crovalimab supported the favourable benefit-risk profile of the Genentech’s candidate, as observed in COMMODORE 2.
Roche chief medical officer and global product development head Levi Garraway said: “People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals.
“As the first global Phase III data for crovalimab, these results emphasize its potential to address these needs. We look forward to submitting these data to regulatory authorities, bringing us one step closer to making crovalimab available for people with PNH around the world.”
In the COMMODORE 2 study, the biotechnology firm randomised the enrolled patients in a 2:1 ratio to be administered with either subcutaneous crovalimab every four weeks or intravenous eculizumab every two weeks.
Genentech plans to submit the findings of both the COMMODORE studies to regulatory authorities globally apart from showcasing them at an upcoming medical meeting.