Genentech, a member of the Roche Group announced positive results from the global Phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors. The study met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). 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.
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“People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “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.”
PNH is a rare and life-threatening blood condition in which red blood cells are destroyed by the complement system. This causes symptoms such as anemia, fatigue, blood clots and kidney disease. C5 inhibitors can be effective in treating the condition. Crovalimab has been engineered to be recycled within the circulation, enabling sustained complement inhibition through low-dose, subcutaneous administration every four weeks.
Data from both studies will be submitted to regulatory authorities around the world and presented at an upcoming medical meeting.
SOURCE: Businesswire