Roche has announced positive results from the phase 3 COMMODORE 2 trial of crovalimab for patients with paroxysmal nocturnal hemoglobinuria (PNH). The results, announced via news release, observed that crovalimab achieved disease control and was not inferior to the current treatment of choice, eculizumab.

“People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said. “As the first global [phase 3] data for crovalimab, these results emphasize its potential to address these needs.”

Crovalimab is a new anti-C5 recycling monoclonal antibody designed to block the complement component of the innate immune system. Crovalimab binds to C5, thereby blocking the last stage of the complement cascade and preventing hemolysis, as do other approved C5 inhibitors. However, crovalimab has a different C5 binding site, which could be advantageous to patients with certain C5 gene mutations who do not respond to currently available treatments.

In the COMMODORE 2 study, adult patients were randomized to be treated with either crovalimab every 4 weeks or eculizumab every 2 weeks. The primary efficacy endpoints of the COMMODORE 2 study were the avoidance of transfusions and hemolysis control.

Read more about PNH therapies

The current randomized, open-label phase 3 trial was launched based on the positive results of the previous phase 3 COMMODORE 1 study on adult and pediatric patients with PNH who switched from other approved C5 inhibitors to crovalimab.

The positive data from both studies will be submitted to regulatory authorities around the world with the aim of bringing crovalimab to patients with PNH globally.


Roche announces positive data from global phase III programme for crovalimab in PNH, a rare life-threatening blood condition. News release. F Hoffman-LaRoche Ltd; February 7, 2023.