CLINICAL RESULTS | Roche Reports Positive Data for Crovalimab as Rare Blood Disease Treatment
Roche has announced positive results from its phase 3 study of crovalimab in patients with paroxysmal nocturnal haemoglobinuria (PNH), a rare and life threatening blood condition.
PNH causes a patient’s red blood cells to break apart, resulting in a range of debilitating symptoms such as anaemia, fatigue, blood clots and kidney disease. The treatment is for PNH patients who have not been previously treated with complement inhibitors.
According to a company press release, crovalimab is designed to control PNH via a subcutaneous injection every four weeks. In this study, crovalimab met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis, or the ongoing destruction of red blood cells. Study results indicated that the drug achieved disease control and was non-inferior to eculizumab, a current standard of care given intravenously every two weeks.
“People
with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals,” said Levi Garraway, Chief Medical Officer and Head of Global Product Development, Roche, in the release.
The company said it will now be submitting data from both studies to regulatory authorities around the world. “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 addition to the results from COMMODORE 2 that enrolled patients who had not been previously treated with C5 inhibitors, the company also reported positive outcomes from its COMMODORE 1 study for PNH patients switching from currently approved C5 inhibitors to crovalimab, which it said ‘supported the favourable benefit-risk profile’ of the drug.
Source: Roche Press Release
