Phesgo and Tecentriq Performance and Approvals
Crovalimab: Positive Ph III results in PNH
Expanding into additional diseases: Ph I in LN initiated
Ph III (COMMODORE 3) results in PNH
Normalization of LDH
Crovalimab development program
ASH 2022
Indication
Ph II
Ph III
Mean normalized LDH
(* ULN)
10
8
N
Phl
COMPOSER
PNH
Paroxysmal
nocturnal
hemoglobinuria
COMMODORE 1 (switch)
EHA 2023
COMMODORE 2 (naïve)
COMMODORE 3 (China)
aHUS
Atypical hemolytic
uremic syndrome
1.5 × ULN
SCD
Sickle cell disease
1 2 3 4 5
13
17
21
25
COMMUTE-a (adults)
COMMUTE-p (pediatric)
CROSSWALK-c (chronic)
CROSSWALK-a (acute)
Time (weeks)
LN
Lupus nephritis
Roche
IR virtual event
June 12th
⚫ Ph Ill China (COMMODORE 3) results show that mean LDH ≤1.5 x ULN was reached by week 3 and maintained through week 25
.
Ph III (COMMODORE 2/1) results show successful disease control in naïve patients, and a favorable benefit-risk profile for patients switching
from other C5 inhibitors; Safety was consistent with the known safety profile of C5 inhibitors; Results to be presented at EHA 2023
.
Filed in China (BTD, Priority Review) with approval expected in 2023; Global filing planned for H1 2023
Liu et al. ASH 2022; PNH-Paroxysmal nocturnal hemoglobinuria; LN-lupus nephritis; LDH-lactate dehydrogenase; ULN-upper limit of normal;; BTD=breakthrough therapy designation
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