Crovalimab, a C5 complement inhibitor, appears to be noninferior to eculizumab for both hemolysis control and transfusion avoidance among patients with paroxysmal nocturnal hemoglobinuria (PNH) who are naïve to complement inhibitors, according to research presented at the EHA 2023 Hybrid Congress.
At the 2023 EHA Congress, researchers presented data from the ongoing COMMODORE 2 study (ClinicalTrials.gov Identifier: NCT04434092), which was designed to determine whether crovalimab is noninferior to eculizumab for multiple clinical endpoints among patients with PNH who have not received prior complement inhibitors.
Overall, 135 patients were randomly assigned to receive crovalimab and 69 patients received eculizumab. In the crovalimab and eculizumab groups, at baseline, the median ages were 36 and 38 years, respectively, 57% and 51% of patients were male sex, and the median hemoglobin levels were 85 and 87 g/L.
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The majority of patients (95.6% in the crovalimab group and 98.6% in the eculizumab group) in the cohort finished 24 weeks of treatment and entered the study’s extension period. Analysis showed that patients in the crovalimab group displayed non-inferiority for both hemolysis control (79.3% vs 79% in the eculizumab group; odds ratio, 1.02; 95% CI, 0.57-1.82) and transfusion avoidance (65.7% vs 68.1%, respectively; weighted difference, -2.8; 95% CI, -15.7-11.1) — meeting the study’s 2 coprimary endpoints.
The study also showed marked improvement in fatigue scores in both groups as measured by the FACIT-Fatigue score; non-inferiority was not, however, evaluated for this metric.
Grade 3 to 5 adverse events were noted in 18% of patients in the crovalimab arm and 25% of patients in the eculizumab arm. “These data highlight the overall favorable benefit-risk profile of crovalimab,” the study’s presenter said.
Disclosures: This research was supported by F. Hoffmann-La Roche Ltd. Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.
Reference
Röth A, He G, Brodsky A, et al. The phase III, randomized COMMODORE 2 trial: results from a multicenter study of crovalimab vs eculizumab in paroxysmal nocturnal hemoglobinuria (PNH) patients naive to complement inhibitors. EHA 2023. June 8-11, 2023. Abstract S181.
