New data show subcutaneously administered crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal hemoglobinuria . Genentech/Roche
Genentech, a member of the Roche Group announced that positive results from the global Phase III COMMODORE 1 and 2 studies, evaluating the efficacy and safety of crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, compared to eculizumab, a current standard of care in paroxysmal nocturnal hemoglobinuria (PNH), were presented at the European Hematology Association (EHA) Hybrid Congress, taking place in Frankfurt, Germany on June 8-11, 2023.
“With the option for subcutaneous self-administration, crovalimab could help meet the lifelong needs of people living with PNH and their caregivers,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Data from the COMMODORE studies will be submitted to regulatory authorities around the world.”
In the COMMODORE 2 study , 79.3% (95% CI: 72.9, 84.5) of participants randomized to be treated with crovalimab achieved hemolysis control from week five to week 25 compared with 79.0% (95% CI: 69.7, 86.0) with eculizumab. Additionally, 65.7% (95% CI: 56.9, 73.5) achieved transfusion avoidance (TA) from baseline to week 25 with crovalimab and 68.1% (95% CI: 55.7, 78.5) with eculizumab. TA is defined as people who become transfusion-free and do not require transfusion per protocol-specified guidelines. Blood transfusion requirements are important clinical measures of hemolysis caused by complement dysregulation in PNH. A clinically meaningful improvement in FACIT-Fatigue score from baseline to week 25 occurred in both arms, with a numerically greater improvement with crovalimab (adjusted mean change 7.8 [95% Cl: 6.5, 9.1]), versus eculizumab (adjusted mean change 5.2 [95% Cl: 3.4, 6.9]).
Adverse events (AEs) occurred in 78% of participants treated with crovalimab and 80% treated with eculizumab in the COMMODORE 2 study. Serious infections occurred in 3% of participants treated with crovalimab and 7% of participants treated with eculizumab, with no meningococcal infections. The most common AE, occurring in 16% of people treated with crovalimab and 13% of people treated with eculizumab was an infusion-related reaction. One participant in each arm experienced an AE that led to treatment discontinuation.
The results from the COMMODORE 1 study indicate that crovalimab maintained disease control in people switching from currently approved complement inhibitors. The data support the consistent benefit-risk profile of crovalimab, as well as SC administration with the option to self-administer, as seen in the COMMODORE 2 study.
Genentech also presented preliminary data from the COMMODORE Burden of Illness study , which suggest that despite currently available C5 inhibitor treatments, people with PNH continue to experience substantial burden of disease, which can translate into diminished quality of life and considerable costs. These data suggest that people with PNH may benefit from alternative treatment options.
Global Phase III data from the COMMODORE 1 and 2 studies in PNH will be submitted to regulatory authorities around the world.
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