Investor Presentaiton
IBI-110 (LAG-3 mAb): 2021 ASCO Data
Promising Preliminary Efficacy and Safety Profile in Phase 1 Study
IBI-110 Phase 1a/1b Study Design & Safety
IBI-110 Phase 1a/1b Study Efficacy Data
IBI110 5 mg/kg +
sintilimab 200mg Q3W
IBI110 3 mg/kg+
sintilimab 200mg Q3W
IBI110 1.5 mg/kg+
sintilimab 200mg Q3W
IBI110 0.7mg/kg +
•
Phase la: IBI110 dose escalation
Advanced solid tumor
3+3 Dose escalation
4 weeks (28 d) DLT obs.
IBI110 iv q3w
IBI110 20 mg/kg
IBI110 10 mg/kg
IBI110 3 mg/kg
IBI110 1 mg/kg
sintilimab 200mg Q3W
DLT completed
IBI110 0.3mg/kg +
IBI110 0.3 mg/kg
sintilimab 200mg Q3W
IBI110 0.1 mg/kg
N=1
IBI110 0.01 mg/kg N=1
Phase Ib: IBI110+ sintilimab dose escalation
PD-X naïve advanced solid tumor
3+3 Dose escalation
4 week (28 d) DLT obs.
IBI110+ sintilimab iv q3w
Figure 1 Clinical Activity in Pts Treated with IBI110+ Sintilimab
0.01mg/kg Mono
0.1mg/kg Mono
0.3mg/kg Mono■
1mg/kg Mono
3mg/kg Mono■
10mg/kg Mono
20mg/kg Mono ■
0.3mg/kg Combo
0.7mg/kg Combo
1.5mg/kg Combo
3mg/kg Combo■
5mg/kg Combo■
▲ PR*
⚫ PD
■Death
⚫ First Combo Dose
+ EOT
Treatment Ongoing
1
2
3
4
5
6
7
8
9
10
11
12
Months
*1 PR in Pt treated with IBI110 monotherapy (ovarian cancer); 2 PR in Pts treated with IBI110+Sintilimab (lung cancer and endometrial cancer);
Table 2 Treatment Related Adverse Events in Phase la
Phase la (n=22)
Table 3 Treatment Related Adverse Events in Phase Ib
Phase Ib (n=18)
All Grade, n (%)
2Grade 3, n (%)
.
All Grade, n (%) ≥Grade 3, n (%)
Any TRAE
12 (66.7)
4 (22.2)
Any TRAE
9 (40.9)
1 (4.5)
AST increased
5 (27.8)
о
Anaemia
4 (18.2)
1 (4.5)
ALT increased
4 (22.2)
0
Anaemia
4 (22.2)
0
Proteinuria
4 (18.2)
0
Rash
4 (22.2)
0
Blood creatinine
2 (9.1)
0
Bilirubin conjugated increased
1 (5.6)
1 (5.6)
increased
Hepatic function abnormal
1 (5.6)
1 (5.6)
Neutrophil count
1 (4.5)
0
Hypertension
1 (5.6)
1 (5.6)
irAE
4 (22.2)
1 (5.6)
decreased
Hypertriglyceridaemia
1 (4.5)
Hypoglycemia
1 (4.5)
irAE
0
000
Hyperglycaemia
Listed all TRAES of 181110 single agent treatment period.
Hypothyroidsm
Hyperthyroidism
Dry mouth
Listed TRAES occurred in more than 20% subjects, any TRAE >Grade 3 and all irAES.
3 (16.7)
0
1 (5.6)
0
1 (5.6)
0
1 (5.6)
1 (5.6)
3 pts with PR when submitted to ASCO2021, including 1 PR with ovarian cancer in
IBI110 monotherapy, 1 PR with endometrium carcinoma and 1 PR with small cell lung
cancer in combination therapy.
Efficacy updated with additional 2 PR with NSCLC failed of standard of care in
combination therapy as of 2021.08
IBI110 alone or plus sintilimab has shown an acceptable safety profile and preliminary anti-tumor activity in the Phase 1 study.
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