New data show Roche’s subcutaneously administered crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH) - Seite 2

Adverse events (AEs) occurred in 78% of participants treated with crovalimab and 80% treated with eculizumab in the COMMODORE 2 study. Serious infections occurred in 3% of participants treated with crovalimab and 7% of participants treated with eculizumab, with no meningococcal infections. The most common AE, occurring in 16% of people treated with crovalimab and 13% of people treated with eculizumab was an infusion-related reaction. One participant in each arm experienced an AE that led to treatment discontinuation.¹

The results from the COMMODORE 1 study indicate that crovalimab maintained disease control in people switching from currently approved complement inhibitors.³ The data support the consistent benefit-risk profile of crovalimab, as well as SC administration with the option to self-administer, as seen in the COMMODORE 2 study.

Roche also presented preliminary data from the COMMODORE Burden of Illness study, which suggest that despite currently available C5 inhibitor treatments, people with PNH continue to experience substantial burden of disease, which can translate into diminished quality of life and considerable costs. These data suggest that people with PNH may benefit from alternative treatment options.⁸

Global phase III data from the COMMODORE 1 and 2 studies in PNH will be submitted to regulatory authorities around the world. Positive data from a third phase III study evaluating crovalimab in PNH, the COMMODORE 3 study in China, were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition on 10 December 2022. Data from the COMMODORE 3 study have been submitted via China’s Centre for Drug Evaluation Breakthrough Therapy Designation pathway. This submission has been accepted under Priority Review for approval consideration by China’s National Medical Products Administration.

About crovalimab
Crovalimab is an investigational, novel anti-C5 recycling monoclonal antibody designed to block the complement system – a vital part of the innate immune system that acts as the body’s first line of defence against infection. Crovalimab, which was created by Chugai Pharmaceutical Co., Ltd, has been engineered to address the medical needs of people living with complement-mediated diseases, including providing patients with a potential self-administration option.