Roche Pharmaceutical Development and Sales Overview
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
Primary endpoint
Status
CT Identifier
"
Phase III
COMMODORE 2
N=200
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ARM A: Crovalimab
ARM B: Eculizumab
Roche
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
% patients with haemolysis control, as measured by LDH <=1.5ULN
from week 5-25
FPI Q4 2020
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
Filed in China (priority review) Q3 2022
NCT04434092
In collaboration with Chugai
LDH-Lactate Dehydrogenase; ULN=Upper Limit of Normal; IV=Intravenous; SC-Subcutaneous
NCT04654468
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ImmunologyView entire presentation