Roche announces new data from Phase 3 COMMODORE 3 study in China

Roche announced new data from the phase III COMMODORE 3 study in China, demonstrating that crovalimab, a novel anti-C5 recycling monoclonal antibody, is efficacious and well-tolerated in people with paroxysmal nocturnal haemoglobinuria. The study met its co-primary efficacy endpoints of transfusion avoidance and haemolysis control, demonstrating that participants with PNH, who have not been treated previously with complement inhibitors and who received subcutaneous crovalimab injections every four weeks, achieved disease control.The data were presented at the American Society of Hematology congress, taking place from 10-13 December 2022." The COMMODORE 3 study included data from 51 participants with PNH, who received crovalimab subcutaneously every four weeks during the primary study period. Results showed that the co-primary efficacy endpoints of haemolysis control and TA, indicators of disease control, were met. The mean proportion of participants with haemolysis control from week five through to week 25 was 78.7%. The difference between the proportion of participants with TA within 24 weeks prior to screening and the proportion of participants with TA from baseline through to week 25 was statistically significant. 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. In addition, the proportion of participants with breakthrough haemolysis from baseline through week 25 was 3.9%, and the proportion of participants who achieved haemoglobin stabilisation was 51%. A rapid and clinically meaningful improvement in fatigue status within two weeks after treatment with crovalimab was also reported and sustained over time, as measured by the FACIT-Fatigue scale. The overall safety data were consistent with the known safety profile of C5 inhibitors and underlying disease, showing that crovalimab was well-tolerated with no new safety signals identified. 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 in PNH by China’s National Medical Products Administration. As the availability of C5 inhibitors is extremely limited in China, there remains a high clinical need for people living with PNH there. Data from the global crovalimab COMMODORE 1 and COMMODORE 2 PNH studies are expected in 2023. Crovalimab is being investigated as a potential treatment option for people living with PNH and other diseases such as atypical haemolytic uraemic syndrome and sickle cell disease.