Investor Presentaiton
IBI-376 (PI3K8) Development Plan Overview
Potential Best-in-class PI3KS Near NDA Stage
IBI-376 demonstrated a high rate of rapid and durable
response in r/r FL and r/r MZL
Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Follicular
Lymphoma (CITADEL-203) (ASH 2020)
Percentage Change From Baseline
501
40-
30-
20
10
0
-10-
-20-
-30
-40-
Weekly Group
Daily Group
-50-
-60-
-70-
-80-
-90-
-100
⚫ 90% (106/118) of efficacy evaluable All Treated Patients and 91% (86/95) of efficacy evaluable
patients in the Daily Group had tumor regression at target lesions
Efficacy Evaluable
Efficacy Evaluable
All Patients
Daily Group
(86 Responders)
(71 Responders)
Median DOR (95% CI), months
15.9 (12.0-NE)
14.7 (12.0-17.5)
IBI-376 (parsaclisib) Development Program Overview
Clinical
Preliminary ORR by IRC
Overall ORR: 73% (95% CI: 64-81)
Efficacy Evaluable All Treated Patients (N=118)*
2% 3%
DG ORR: 75% (95% CI: 65-83)
progress
Efficacy Evaluable DG (N=95)*
2% 2%
6%
14%
CR
17%
SD
CR
14%
CR
PR
15%
SD
SD
PD
59%
PR
NE
NA
61%
PR
77% of responses occurred at first assessment
ORR by investigator assessment efficacy evaluable All Treated Patients 73% (95% CI: 64-81)
Efficacy Evaluable
All Patients
(N=118)
Median PFS (95% CI), months
15.8 (13.2-19.3)
Efficacy Evaluable
Daily Group
(N=95)
15.8 (13.8-19.1)
WG: 20mg, qd, 8 weeks; 20mg, qw afterward; DG: 20mg, qd, 8 weeks; 2.5mg, qd afterward;
Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Marginal
Zone Lymphoma (CITADEL-204) (ASH 2020)
r/r FL and MZL
Have completed enrolment of pivotal Phase 2 trial for IBI-376 for
r/r FL in China
2021 plan
•
r/r FL and MZL
Plan to submit NDA to NMPA for IBI-376 for r/r FL between
late 2021 to early 2022
Myselofibrosis
-
Plan to start patient enrolment of IBI-376 in China for Incyte-
sponsored Phase 3 trial for 2L myelofibrosis by 2021
Efficacy Compared within Different PI3K Inhibitors
IRC Assessment
ORR: 57.0%
ORR: 56.9%
95% CI: 46.7-66.9
95% CI: 44.7-68.6
70%
50%
40%
51.0%
30%
51.4%
PR
20%
30.0%
SD
10%
6.0%
31.9%
SD
5.6%
est Percentage Change From Baseline
100-
80-
60-
40
20-
0
-20-
-40-
-60-
-80-
-100-
Target lesion size
Spleen size
Medicine
Target
Parsaclisib
(US data)
PI3Kō
Incyte
Idelalisib
PI3Kō
Gilead
Duvelisib
PI3Kō, Y
Infinity
.
All Treated Patients
(N = 100)
Daily Group
(N=72)
CI, confidence interval; CR, complete response; PR, partial response; SD, stable disease.
67% (38/57) of responders had an objective response (CR or PR) at first assessment
⚫ Median time to first response was 8.1 weeks
Umbralisib
PI3Kō
All Treated Patients
(57 Responders)
Daily Group
(41 Responders)
All Treated Patients
(N = 100)
Daily Group
(N = 72)
Median DOR (95% CI), months
12.0 (9.3-NE)
NR (8.1-NE)
Median PFS (95% CI), months
19.4 (13.7-NE)
NR (11.0-NE)
Copanlisib
PI3K
Bayer
NE, not evaluable; NR, not reached.
Co.
DLBCL (n)
30% (23)
Efficacy-ORR, %
FL (n)
73% (118)
MCL (n)
67% (9)
MZL (n)
57% (100)
NA
54% (72)
40%
57%
NA
41%*(83)
NA
33% (18)
TG
27% (11)
45% (22)
79% (11)
NA
Therapeutics
25% (40)
58.7% (104)
64% (11)
69.6 %
IBI-376 is a highly selective, potent and differentiated PI3K inhibitor designed to reduce hepatotoxicity.
IBI-376 shows the best-in-class potential in multiple B cell malignancies. Plan to file NDA in China in end 2021 to early 2022.
Innovent
Confidential
Copyright©2021 Innovent Biologics
24View entire presentation