Genentech shares positive results from global phase 3 trials for crovalimab in PNH

pharmafile | February 7, 2023 | News story | Medical Communications  

Following the global COMMODORE 2 study, Genentech has announced positive data for crovalimab in treating patients with paroxysmal nocturnal haemoglobinuria (PNH) who have not been treated with complement inhibitors already. The phase 3 studies met their primary efficacy endpoints and achieved disease control, with the results expected to be submitted to regulatory authorities in the coming months.

Throughout the study, crovalimab met its co-primary efficacy endpoints of transfusion avoidance and control of haemolysis, which is the ongoing destruction of red blood cells which can be measured by the levels of lactate dehydrogenase. The drug, when administered as a subcutaneous injection every four weeks, was shown to achieve disease control and was non-inferior to eculizumab, the current standard of care.

The phase 3 COMMODORE 1 study also showed that patients switching from currently approved C5 inhibitor treatments to crovalimab also benefitted, further supporting the drug’s positive benefit-risk profile, which was maintained throughout the COMMODORE 2 trial.

PNH is a life-threatening blood condition which sees red blood cells destroyed by the complement system, causing symptoms including: anemia, fatigue, blood clots and kidney disease.

Levi Garraway, MD PhD, chief medical officer and head of Global Product Development at Genentech, commented: “People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals. As the first global phase 3 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.”


Betsy Goodfellow

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