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IPIG 2025 | COMMODORE 1 and 2 trials: breakthrough hemolysis events in PNH treated with crovalimab or eculizumab
Catherine Flynn, MD, St James’s Hospital, Dublin, Ireland, discusses the characterization of breakthrough hemolysis events in patients with paroxysmal nocturnal hemoglobinuria (PNH) treated with crovalimab or eculizumab on the Phase III COMMODORE 1 and 2 trials (NCT04432584 and NCT04434092, respectively). Dr Flynn notes that these trials found similar rates of breakthrough hemolysis events with both agents, but with different underlying causes. Breakthrough hemolysis events on crovalimab were predominantly associated with complement-activating situations (CACs), while those with eculizumab occurred due to pharmacokinetic or pharmacodynamic reasons. This interview took place at the 2nd International PNH Interest Group (IPIG) Conference in Paris, France.
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Transcript
So this is one of the primary endpoints of the trial COMMODORE 1 and COMMODORE 2. These trials were set up to look at the safety and endpoints of breakthrough hemolysis and transfusion independence for patients on crovalimab compared to eculizumab. Both of these medications are C5 inhibitors, however crovalimab is given every four weeks and it’s given by a subcutaneous injection which patients can self-administer...
So this is one of the primary endpoints of the trial COMMODORE 1 and COMMODORE 2. These trials were set up to look at the safety and endpoints of breakthrough hemolysis and transfusion independence for patients on crovalimab compared to eculizumab. Both of these medications are C5 inhibitors, however crovalimab is given every four weeks and it’s given by a subcutaneous injection which patients can self-administer. The poster itself demonstrates that the breakthrough hemolysis events were similar on both medications. However, the breakthrough events in the crovalimab arm were mainly associated with CACs which is a complement activating situation like an infection or pregnancy or surgery; whereas the eculizumab arm seems to be more associated with breakthrough events likely due to pharmacokinetic or pharmacodynamic, whereby the drug may not be in sufficient quantity in the patient’s system. Interestingly, crovalimab is dose-adjusted based on weight, whereas eculizumab is a fixed dose, so those may be contributory.
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Disclosures
CF is a PI on the COMMODORE trials.
