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

The results from the COMMODORE 1 study indicate that crovalimab maintained disease control in people switching from currently approved complement inhibitors. 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.

Genentech 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.

Global Phase III data from the COMMODORE 1 and 2 studies in PNH will be submitted to regulatory authorities around the world.

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.

Crovalimab works by binding to C5, blocking the last step of the complement cascade and is also recycled within the bloodstream, enabling rapid and sustained complement inhibition. Crovalimab’s recycling properties also enable low-dose SC administration every four weeks. In addition, crovalimab binds to a different C5 binding site from current treatments, which has the potential to provide a treatment option for people with specific C5 gene mutations, who do not respond to current therapies. It is also being evaluated in atypical hemolytic uremic syndrome, sickle cell disease and other complement-mediated diseases.