Crovalimab, a novel complement C5 inhibitor, has demonstrated efficacy and safety in complement inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria (PNH) enrolled in the phase 3, single-arm COMMODORE 3 study (NCT04654468).
The study met the proposed co-primary efficacy endpoints, with a mean proportion of 78.7% of patients achieving hemolysis control and a significant difference in transfusion avoidance (51.0% from baseline through week 25 vs 0% within 24 weeks of prescreening).
Moreover, crovalimab was well-tolerated, with no treatment-related discontinuations and 1 treatment-unrelated death.
“COMMODORE 3 showed that, following training by a healthcare professional, unsupervised self-administration is a feasible option that can reduce the burden of this life-long treatment. Risks associated with self-administration can be managed with proper training in subcutaneous injection technique,” the study’s authors wrote in the American Journal of Hematology.
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During the enrollment period (March 17, 2021-August 24, 2021), patients received crovalimab loading doses (1 intravenous and 4 subcutaneous) followed by every-4-weeks subcutaneous maintenance doses based on a weight-based tiered-dosing schedule.
The study’s co-primary efficacy endpoints were the mean proportion of patients with hemolysis control from weeks 5 through 25 and the difference in the proportion of patients with transfusion avoidance from baseline through week 25 compared to within 24 weeks of prescreening, for patients who received at least 1 crovalimab dose and had at least 1 central lactate dehydrogenase assessment after the first dose.
COMMODORE 3 enrolled 51 patients with PNH, aged 15 to 58 years, who were complement inhibitor-naive. Patients were recruited from 5 centers in mainland China, where C5 inhibitors are not easily accessible and the primary treatment is best supportive care, including transfusions, supplementary iron and folic acid, and corticosteroids.
Reference
Liu H, Xia L, Weng J, et al. Efficacy and safety of the C5 inhibitor crovalimab in complement inhibitor-naive patients with PNH (COMMODORE 3): a multicenter, phase 3, single-arm study. Am J Hematol. Published online July 8, 2023. doi:10.1002/ajh.26998
