" class="no-js "lang="en-US"> Roche Announces Positive Study Data for Rare Blood Condition
Saturday, April 01, 2023

Roche Announces Positive Data from Global Phase III Programme for Crovalimab in PNH, a Rare Life-threatening Blood Condition

Roche has announced positive results from the global phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal haemoglobinuria (a rare life-threatening blood condition) who have not been previously treated with complement inhibitors. The study met its co-primary efficacy endpoints of transfusion avoidance and control of haemolysis (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 favourable 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., Roche’s Chief Medical Officer and Head of Global Product Development. “As the first global phase III data for crovalimab, these results emphasise 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 anaemia, 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. Positive data from the phase III COMMODORE 3 study in China were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition on 10 December 2022. Data from the COMMODORE 3 study have been submitted via China’s Centre for Drug Evaluation Breakthrough Therapy Designation pathway. This submission has been accepted under Priority Review for approval consideration by China’s National Medical Products Administration.

Companies In This Post

  1. Insmed Completes Enrollment of Adult Patients in Phase 3 ASPEN Study of Brensocatib in Bronchiectasis Read more
  2. NEC Establishes Subsidiaries in Europe for Strengthening Global AI Drug Development Business Read more
  3. Flare Therapeutics Further Strengthens Leadership Team with Key Executive Appointments and Promotions Read more
  4. Sensorion Appoints Khalil Barrage as Interim Chairman of the Board Read more
  5. Ablaze Pharmaceuticals Plans Development of Innovative GPC3 Targeted Radiopharmaceutical Therapy for Liver Cancer in Greater China Read more