Roche's less frequently dosed crovalimab matches Soliris, meets phase 3 trial goals in rare blood disorder
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Roche (OTCQX:RHHBY) (OTCQX:RHHBF) said its medicine crovalimab met the main goal of a phase 3 study and helped achieve disease control in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors.
PNH is a rare disorder in which certain red blood cells break apart prematurely. These defective red blood cells are destroyed by part of the body's own immune system called the complement system. The disorder causes symptoms such as anemia, fatigue, blood clots and kidney disease, according to the company.
Patients were randomized in a 2:1 ratio to be treated with either subcutaneous (SC) crovalimab every four weeks or intravenous (IV) eculizumab, sold as Soliris by AstraZeneca (NASDAQ:AZN), every two weeks.
The Swiss pharma giant said the study, dubbed COMMODORE 2, met its co-primary efficacy goals of transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells).
Results showed that crovalimab, a novel, investigational anti-C5 recycling monoclonal antibody, given as a subcutaneous injection every four weeks, achieved disease control and was non-inferior to eculizumab, a current standard of care, which is given intravenously every two weeks, the company added.
Roche noted that the efficacy and safety data from a separate phase 3 trial called COMMODORE 1, in people with PNH switching from currently approved C5 inhibitors to crovalimab, supported the favorable benefit-risk profile of crovalimab, as seen in the COMMODORE 2 study.
"People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals," said Levi Garraway, Roche's chief medical officer and head of Global Product Development. "As the first global phase III data for crovalimab, these results emphasize its potential to address these needs.
Roche said data from both studies will be submitted to regulatory authorities and presented at an upcoming medical meeting.
Meanwhile, data from the phase 3 study called COMMODORE 3 has been submitted in China and is currently under priority review by the Chinese drug regulator.