Crovalimab confers disease control in paroxysmal nocturnal hemoglobinuria
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Crovalimab provided disease control and proved noninferior to a current standard-of-care treatment for certain patients with paroxysmal nocturnal hemoglobinuria, according to the agent’s manufacturer.
Crovalimab (Genentech), a novel anti-C5 recycling monoclonal antibody, blocks the complement system. The randomized phase 3 COMMODORE 2 study evaluated its efficacy and safety vs. eculizumab (Soliris, Alexion Pharmaceuticals), a current standard of care, among people with paroxysmal nocturnal hemoglobinuria who had not previously been treated with C5 inhibitors.
Researchers randomly assigned patients 2:1 to treatment with subcutaneous crovalimab every 4 weeks or IV eculizumab every 2 weeks. Study participants aged younger than 18 years received subcutaneous crovalimab every 4 weeks in a nonrandomized treatment arm.
Results showed crovalimab led to transfusion avoidance and control of hemolysis — the study’s co-primary endpoints — thus, achieving disease control. It also demonstrated noninferiority to eculizumab.
“People with [paroxysmal nocturnal hemoglobinuria] may benefit from more options to achieve robust disease control with less frequent treatment intervals,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a press release. “As the first global [phase 3] data for crovalimab, these results emphasize its potential to address these needs.”
Efficacy and safety data from the randomized phase 3 COMMODORE 1 study of patients with paroxysmal nocturnal hemoglobinuria who switched to crovalimab from approved C5 inhibitors supported the favorable benefit-risk profile of crovalimab.
Data from both studies will be presented at an upcoming medical meeting.
Crovalimab also is under evaluation in atypical hemlytic uremic syndrome, sickle cell disease and other complement-mediated diseases, according to the press release.
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