Roche has reported positive data from the global Phase III COMMODORE 2 study of crovalimab in paroxysmal nocturnal haemoglobinuria (PNH) patients.
The open-label, randomised Phase III study was designed to assess the safety and efficacy of crovalimab against eculizumab in PNH patients, who have previously not received treatment with C5 inhibitors.
In the trial, adult participants were randomised in a 2:1 ratio to receive either subcutaneous (SC) crovalimab every four weeks, or intravenous (IV) eculizumab every two weeks.
Findings showed that the trial met its co-primary efficacy endpoints, demonstrating crovalimab achieved disease control in these patients.
Crovalimab was also found to be non-inferior to eculizumab, which is a standard of care given intravenously every two weeks.
The company stated that the findings from the Phase III COMMODORE 1 study, which was conducted in PNH patients switching from currently approved C5 inhibitors to crovalimab, supported the therapy’s favourable benefit-risk profile, as seen in the pivotal COMMODORE 2 study.
Roche Global Product Development head and chief medical officer 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 emphasise 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.”
The company intends to submit the data from both studies to regulatory authorities across the world.
Recently, Roche and CARsgen Therapeutics entered into a collaboration agreement to evaluate AB011, along with atezolizumab, to treat gastric cancer.