Roche’s Crovalimab Trial Reaches Endpoints in Patients With PNH

Roche subsidiary Genentech announced positive results from its global phase 3 COMMODORE 2 study evaluating crovalimab for people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors.

The head-to-head study compared crovalimab, dosed monthly, to AstraZeneca’s Soliris (eculizumab), the current standard of care in PNH, dosed bi-weekly. The study met its co-primary efficacy endpoints, demonstrating noninferiority to eculizumab on measures of disease control.

PNH is a rare and life-threatening blood condition in which red blood cells are destroyed by the complement system. This causes symptoms such as anemia, fatigue, blood clots and kidney disease. Crovalimab has been engineered to be recycled within the circulation, enabling sustained complement inhibition through low-dose, subcutaneous administration every four weeks.

COMMODORE-2 was a randomized, open-label study with 200 PNH patients who had not been previously treated with C5 inhibitors. The patients were randomized to either subcutaneous crovalimab every four weeks or intravenous eculizumab every two weeks.

The study met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells), thus achieving disease control, with noninferiority to eculizumab.

Roche previously reported positive data from the COMMODORE 1 study in people with PNH switching from currently approved C5 inhibitors to crovalimab. Data from both studies will be submitted to global regulatory authorities and presented at an upcoming medical meeting.