Roche reports COMMODORE 2 study met co-primary efficacy endpoints

Roche announced results from the global phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal haemoglobinuria, or PNH, who have not been previously treated with complement inhibitors. The study met its co-primary efficacy endpoints of transfusion avoidance and control of haemolysis. Results showed that crovalimab, a novel, investigational anti-C5 recycling monoclonal antibody, given as a subcutaneous injection every four weeks, achieved disease control and was non-inferior to eculizumab, a current standard of care, which is given intravenously every two weeks. The efficacy and safety data from the separate phase III COMMODORE 1 study in people with PNH switching from currently approved C5 inhibitors to crovalimab, supported the favorable benefit-risk profile of crovalimab, as seen in the pivotal COMMODORE 2 study, the company stated. "Data from both studies will be submitted to regulatory authorities around the world and presented at an upcoming medical meeting. Positive data from the phase III COMMODORE 3 study in China were presented at the American Society of Hematology – ASH – Annual Meeting and Exposition on 10 December 2022. Data from the COMMODORE 3 study have been submitted via China’s Centre for Drug Evaluation Breakthrough Therapy Designation pathway. This submission has been accepted under Priority Review for approval consideration by China’s National Medical Products Administration," Roche said.