Half-Year 2022 Financial and Clinical Trials Update
Crovalimab (RG6107; SKY59)
A humanized monoclonal antibody against complement C5
Indication
Paroxysmal nocturnal hemoglobinuria (PNH)
C5 inhibitor naive patients
Paroxysmal nocturnal hemoglobinuria (PNH)
C5 inhibitor naive patients (China only)
Phase/study
# of patients
Design
Phase III
COMMODORE 2
N=200
ARM A: Crovalimab
ARM B: Eculizumab
Phase III
COMMODORE 3
N=51
▪ Crovalimab loading dose IV on Day 1, followed by weekly crovalimab SC
doses for 4 weeks
Non-inferiority of crovalimab compared to eculizumab:
- % patients with transfusion avoidance from baseline through week 25
Primary endpoint
Status
CT Identifier
- % patients with haemolysis control, as measured by LDH <=1.5ULN from
week 5-25
FPI Q4 2020
NCT04434092
▪ Percentage of patients with transfusion avoidance from baseline through
week 25
Mean percentage of participants with hemolysis control (week 5 through
week 25)
▪ FPI Q1 2021
■ Recruitment completed Q3 2021
▪ Study met its co-primary endpoints Q1 2022
NCT04654468
In collaboration with Chugai
LDH-Lactate Dehydrogenase; ULN=Upper Limit of Normal; IV=Intravenous; SC-Subcutaneous
140
Roche
ImmunologyView entire presentation