New Data Show Roche's Self-Administered Blood Disorder Candidate Achieves Disease Control

Jun 9, 202315:25 UTC

Roche Group Holdings AG's RHHBY data from the global phase 3 COMMODORE 1 and 2 studies evaluating crovalimab compared to eculizumab, a current standard of care in paroxysmal nocturnal hemoglobinuria (PNH), were presented at the European Hematology Association Hybrid Congress.

In the COMMODORE 2 study, 79.3% of participants randomized to be treated with crovalimab achieved hemolysis control from week five to week 25 compared with 79.0% with AstraZeneca Plc's AZN Soliris (eculizumab).

AstraZeneca reported danicopan data showing that danicopan as an add-on to the standard of care C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) demonstrated a statistically significant and clinically meaningful increase in hemoglobin levels and maintained disease control in PNH patients, compared to placebo plus established C5 inhibitor therapy.

The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks was non-inferior to intravenous eculizumab every two weeks, with comparable safety, in people new to C5 inhibitors.

Additionally, 65.7% achieved transfusion avoidance (TA) from baseline to week 25 with crovalimab and 68.1% with eculizumab.

The results from the COMMODORE 1 study indicate that crovalimab maintained disease control in people switching from currently approved complement inhibitors.

Roche says monthly self-administration of subcutaneous crovalimab has the potential to address the high burden of a disease that requires lifelong treatment, including in settings where access to current C5 inhibitors is limited.