Following an initial i.v. loading dose, crovalimab is administered once every 4 weeks as a subcutaneous injection by the patient themselves or by a caregiver.[1][2] Administration can also be done in the clinic if self-injection is not desired by the doctor or the patient.[1][2]
Crovalimab is the subject of five Phase III studies for PNH and atypical hemolytic uremic syndrome (aHUS). It is also being investigated for the treatment of sickle cell disease and other conditions.[6]
Clinical trials
Three Phase 3 clinical trials have evaluated crovalimab in both patients who were C5 inhibitor–naive and those switching to crovalimab from other C5 inhibitors.
COMMODORE 1[7] is a Phase III randomized clinical trial comparing crovalimab vs eculizumab in PNH patients treated with C5 inhibitors.[4] COMMODORE 1 examines the safety, tolerability and pharmacokinetic/pharmacodynamic properties of crovalimab in PNH patients switching from eculizumab. The study showed that crovalimab maintained disease control in PNH patients switching from eculizumab.
COMMODORE 2[8] is a Phase III randomized trial comparing crovalimab vs eculizumab in people with PNH who are naive to C5 inhibitor treatment.[5] COMMODORE 2 was positive for its co-primary endpoints, transfusion avoidance and hemolysis control (measured lactate dehydrogenase levels) which are disease control indicators, and its data shows crovalimab is non-inferior to eculizumab.
COMMODORE 3[9] is a Phase III single-arm trial run in China, studying crovalimab in C5 inhibitor-naive patients with PNH.[2] COMMODORE 3 assessed the safety, efficacy, pharmacokinetics, and pharmacodynamics of crovalimab in c5-naive PNH patients. The study met the co-primary efficacy endpoints of haemolysis control and transfusion avoidance.
Approval
Crovalimab was approved for use in China in February 2024[10] and in Japan in April 2024.[11]