New data show Roche’s subcutaneously administered crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH)

• The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks was non-inferior to intravenous eculizumab every two weeks, with comparable safety, in people new to C5 inhibitors¹
• Monthly self-administration of subcutaneous crovalimab has the potential to address the high burden of a disease that requires lifelong treatment including in settings where access to current C5 inhibitors is limited^1,2
• The COMMODORE 1 study in people switching from currently approved C5 inhibitors supported the consistent benefit-risk profile of crovalimab as seen in the COMMODORE 2 study³
  
  

Basel, 09 June 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 haemoglobinuria (PNH) were presented at the European Hematology Association (EHA) Hybrid Congress, taking place in Frankfurt, Germany on 8-11 June 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., Roche’s 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 anaemia, fatigue, blood clots and kidney disease.⁴ C5 inhibitors have been shown to be effective in treating the condition.⁵ Crovalimab has been engineered to be recycled within the bloodstream, enabling sustained complement inhibition through low dose, subcutaneous (SC) administration every four weeks.^6,7

In the COMMODORE 2 study, 79.3% (95% CI: 72.9, 84.5) of participants randomised to be treated with crovalimab achieved haemolysis 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 haemolysis 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)).¹