Crovalimab Noninferior to Eculizumab for Paroxysmal Nocturnal Hemoglobinuria

Positive results were announced from a phase 3 study evaluating the efficacy and safety of crovalimab in adult and pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).

Crovalimab is an investigational, novel anti-complement 5 (C5) recycling monoclonal antibody. The COMMODORE 2 study (ClinicalTrials.gov Identifier: NCT04434092) was designed to evaluate the noninferiority of crovalimab compared with eculizumab in patients with PNH who have not been previously treated with complement inhibitor therapy.

Study participants were randomly assigned 2:1 to receive either crovalimab subcutaneously every 4 weeks or eculizumab intravenously every 2 weeks. Patients who were less than 18 years of age were included in a nonrandomized treatment arm and received crovalimab subcutaneously every 4 weeks.

The coprimary endpoints were the percentage of patients who achieved transfusion avoidance (defined as patients who are packed red blood cell [pRBC] transfusion-free and do not require transfusion per protocol-specified guidelines) and the percentage of patients with hemolysis control (measured by lactate dehydrogenase of ≤1.5 x upper limit of normal), from baseline through week 25.

Findings showed crovalimab was noninferior to eculizumab for both primary endpoints. Treatment with crovalimab demonstrated disease control in PNH patients who had not been previously treated with complement inhibitors.

The favorable benefit-risk profile of crovalimab is also supported by data from the phase 3 COMMODORE 1 study (ClinicalTrials.gov Identifier: NCT04432584), which included PNH patients switching from currently approved C5 inhibitors to crovalimab.

Full study data from both trials will be presented at an upcoming medical meeting.

“People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “As the first global phase 3 data for crovalimab, these results emphasize its potential to address these needs. We look forward to submitting these data to regulatory authorities, bringing us one step closer to making crovalimab available for people with PNH around the world.”

Reference

Genentech announces positive data from global phase III program for crovalimab in PNH, a rare, life-threatening blood condition. News release. Genentech. Accessed February 7, 2023. https://www.businesswire.com/news/home/20230206005656/en/Genentech-Announces-Positive-Data-From-Global-Phase-III-Program-for-Crovalimab-in-PNH-a-Rare-Life-Threatening-Blood-Condition.