Crovalimab May Be Well-Tolerated Among Patients With PNH Who Have Received Prior Complement Inhibitors

Crovalimab appears to be well-tolerated among patients with paroxysmal nocturnal hemoglobinuria (PNH) who have received prior complement inhibitor therapy, according to research presented at the EHA 2023 Hybrid Congress.

Crovalimab, an anti-C5 monoclonal antibody, requires self-administration by the patient only once per 4-week period, which may help to improve patient quality of life.

Previous research has suggested that crovalimab may be safe and effective among patients with PNH who are complement inhibitor-naïve. For the randomized phase 3 COMMODORE 1 study (ClinicalTrials.gov Identifier: NCT04432584), researchers are evaluating the safety and efficacy of crovalimab among patients with PNH who have received prior complement inhibitor therapy. The study’s primary endpoint is safety; exploratory efficacy endpoints include hemolysis control and transfusion avoidance.

Overall, 89 patients had been randomly assigned to receive crovalimab (45 patients) or eculizumab (44 patients) by data cutoff; 87% and 80% of patients, respectively, completed the preplanned 24-week treatment cycle and entered the study’s extension period. Baseline characteristics were generally balanced between the 2 arms.

Of the 86 patients (44 in the crovalimab group, 42 in the eculizumab group) included in the safety analysis, 77% and 67% of patients, respectively, had at least 1 adverse event; 14% and 2% had a serious event. The study’s presenter suggested, however, that this higher rate of toxicity was due to risks “unique to the crovalimab arm.”

Through week 25, hemolysis control and transfusion avoidance rates were similar between the 2 arms. “These data highlight the overall favorable benefit-risk profile of crovalimab,” the 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

Scheinberg P, Cle D, Edwards J, et al. Phase III randomized, multicenter, open-label COMMODORE 1 trial: comparison of crovalimab vs eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria (PNH). EHA 2023. June 8-11, 2023. Abstract S183.