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.
Go deeper with GlobalData
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.
See Also:
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataRoche 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.
