Pharma Update
Crovalimab: Expanding program in complement-mediated diseases
Positive Ph III data in PNH filed globally; US filing accepted on 1 Sep
Crovalimab (anti-C5 recycling Ab)
Broad development program in complement mediated diseases
C5 SNP
Indication
Phl
Ph II
Ph III
COMPOSER
Paroxysmal
COMMODORE 1 (switch)
PNH nocturnal
hemoglobinuria
COMMODORE 2 (naïve)
5
aHUS
Atypical hemolytic
uremic syndrome
SCD
Sickle cell disease
COMMODORE 3 (China)
COMMUTE-a (adults)
COMMUTE-p (pediatric)
CROSSWALK-c (chronic)
CROSSWALK-a (acute)
LN
Lupus nephritis
Endosome
Recycling
4
Receptor,
FcRn
Lysosome
Roche
Filed
• Uses Chugai's recycling antibody technology
(SMART-Ig)1-6
•
•
Rapid, long-lasting neutralization of C5 in
complement mediated diseases
Low volume administration supports convenient
SC Q4W dosing at home
Ph III (COMMODORE 2/1) results in PNH show successful disease control in naïve patients and a
favorable benefit-risk profile for patients switching from other C5 inhibitors
Clear dosing advantage over current C5 inhibitors with the majority of COMMODORE 2/1 patients
preferring crovalimab over previous therapy
Filed globally in PNH; first approvals expected in 2024
1 Röth A et al. Blood 2020;135:912-20; 2 Fukuzawa T et al. Sci Rep 2017;7:1080; 3 Sampei Z et al. PLoS One 2018; 13:e0209509; 4 Röth A, Nishimura J. Centro Congressi Federico II 2019; 5 Röth A et al. ASH 2018; 6 Sostelly A et al. ASH
2019; PNH-paroxysmal nocturnal hemoglobinuria; Ab-antibody; SC=subcutaneous; Q4W-every 4 weeks; aHUS-atypical hemolytic uremic syndrome; SCD-Sickle cell disease; LN-lupus nephritis
96
96View entire presentation