Genentech Announces Positive Data From Global Phase III Program for Crovalimab in PNH, a Rare, Life-Threatening Blood Condition

– The COMMODORE 2 study met its co-primary efficacy endpoints, showing crovalimab achieved disease control in people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors –

– The results of the Phase III COMMODORE 1 study in people with PNH switching from currently approved C5 inhibitors supported the favorable benefit-risk profile of crovalimab, as seen in the pivotal COMMODORE 2 study –

– Results from both studies will be submitted to regulatory authorities around the world and presented at an upcoming medical meeting –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the global Phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors. The study met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). 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 efficacy and safety data from the separate Phase III COMMODORE 1 study in people with PNH switching from currently approved C5 inhibitors to crovalimab supported the favorable benefit-risk profile of crovalimab, as seen in the pivotal COMMODORE 2 study.

“People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals,” said Levi Garraway, M.D., Ph.D., 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. We look forward to submitting these data to regulatory authorities, bringing us one step closer to making crovalimab available for people with PNH around the world.”

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. C5 inhibitors can be effective in treating the condition. Crovalimab has been engineered to be recycled within the circulation, enabling sustained complement inhibition through low-dose, subcutaneous administration every four weeks.

Data from both studies will be submitted to regulatory authorities around the world and presented at an upcoming medical meeting.

About the COMMODORE 1 and 2 studies

The COMMODORE 2 study is a Phase III, randomized, open-label study evaluating the efficacy and safety of crovalimab versus eculizumab in people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with C5 inhibitors. The study’s co-primary efficacy endpoints measure transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). The adults enrolled in the study were randomized in a 2:1 ratio to be treated with either subcutaneous (SC) crovalimab every four weeks or intravenous (IV) eculizumab every two weeks. The participants who were less than 18 years old were included in a non-randomized treatment arm and were treated with SC crovalimab every four weeks.

The COMMODORE 1 study is a Phase III, randomized, open-label study evaluating the safety of crovalimab in people with PNH switching from currently approved C5 inhibitors. The study’s outcome measures evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of crovalimab. The study included people (18 years of age or older) currently treated with eculizumab. In a non-randomized arm, the study also included pediatrics (<18 years of age) currently treated with eculizumab, people currently treated with ravulizumab, people currently treated with off-label doses of eculizumab (higher than the approved dose for PNH: more than 900 mg per dose and/or more frequently than every two weeks) or people with known mutations in the C5 gene who do not respond to current therapies.

About Crovalimab

Crovalimab is an investigational, novel anti-C5 recycling monoclonal antibody designed to block the complement system, a vital part of the innate immune system that acts as the body’s first line of defense against infection. Crovalimab has been engineered to address the medical needs of people living with complement-mediated diseases, including providing patients with a potential at-home administration option.

Crovalimab works by binding to C5, blocking the last step of the complement cascade and is also recycled into circulation, enabling rapid and sustained complement inhibition. Crovalimab’s recycling action also enables low-dose SC administration every four weeks. In addition, crovalimab binds to a different C5 binding site from current treatments, which has the potential to provide an effective treatment option for people with specific C5 gene mutations, who do not respond to current therapies. Crovalimab is being investigated in a clinical development program including five ongoing Phase III studies. Crovalimab is being evaluated in PNH, atypical hemolytic uremic syndrome, sickle cell disease and other complement-mediated diseases.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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