New Data Show Genentech’s Subcutaneously Administered Crovalimab Achieved Disease Control and Was Well-Tolerated in People With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today 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.”

PNH is a rare and life-threatening blood condition, in which red blood cells are destroyed by the complement system — part of the innate immune system — causing symptoms such as anemia, fatigue, blood clots and kidney disease. C5 inhibitors have been shown to be effective in treating the condition. Crovalimab has been engineered to be recycled within the bloodstream, enabling sustained complement inhibition through low-dose, subcutaneous (SC) administration every four weeks.

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]).