Investor Presentaiton
Clinical Data of HLX22-GC-201
Data cut-off date: 2023/07/30; median follow-up duration: 14.3 months
The clinical data of Phase II study (HLX22-GC-201) of HLX22 (an innovative anti-HER2 mAb)+HANQUYOU (HLX02, trastuzumab)+XELOX for the 1L HER2-positive
gastric/gastroesophageal junction (G/GEJ) cancer was presented in the posters at 2024 ASCO GI
The results of this study demonstrated that adding HLX22 to trastuzumab + XELOX was safe and improved survival and antitumor response in patients with HER2-positive G/GEJ cancer
in the first-line treatment. HLX22+HLX02+XELOX, as the 1L treatment for HER2-positive G/GEJ cancer also shown good tolerance, with the most common treatment-related adverse
events (AEs) of neutrophil and leukocyte count decreased and anemia
HLX22+ trastuzumab +XELOX warrants further large-scale investigation and could be a new 1L treatment option for HER2-positive G/GEJ cancers. Currently, no similar HER2 dual-target
treatment for HER2-positive GC has been approved globally
Product
Clinical Trial
Regimen
Sample Size
mPFS (months)
mOS (months)
A: HLX22 (25 mg/kg)+Trastuzumab+chemo
(XELOX)
15.1 vs NR vs 8.2
ITT population
HLX22
HLX22-GC-201 (Ph II) B: HLX22 (15 mg/kg)+Trastuzumab+chemo
(XELOX)
18 vs 17 vs 18
A vs C: HR=0.5, p=0.1272 A vs C:
B vs C: HR=0.1, p=0.0007 B vs C:
NR vs NR vs NR
HR=0.4, p=0.1621
HR=0.3, p=0.0894
C: Trastuzumab+chemo (XELOX)
KEYNOTE-8111 (Ph
ITT population
III)
350 vs 348
EMA: approved for
A: Pembrolizumab+Trastuzumab+chemo
Pembrolizumab PD-L1+ subgroup;
(CF/XELOX)
298 vs 296
FDA: expediated
approved for PD-L1+
subgroup
B: Trastuzumab+chemo (CF/XELOX)
IA3: NA
Trastuzumab
TOGA², 3 (Ph III)
A: Trastuzumab+chemo (CF/CX)
B: chemo (CF/CX)
PD-L1+ subgroup
PD-L1-subgroup
52 vs 52
Adjusted ITT population
294 vs 290
China subgroup
IA2: 10.0 vs 8.1
HR=0.72, p=0.0002
IA2: 10.8 vs 7.2
HR=0.70, p NA
IA2: 9.5 vs 9.6
HR 1.17, p NA
6.7 vs 5.5
HR=0.71, p = 0.0002
6.8 vs 5.5
HR=0.69, p NA
8.5 vs 7.0
HR=0.73, p = 0.0001
IA3 20.0 vs 16.8
HR=0.84, p NA
IA3: 20.0 vs 15.7
HR=0.81, p NA
IA2 16.1 vs 22.3
HR=1.61, p NA
13.8 vs 11.1
HR=0.74, p=0.0046
12.6 vs 9.7
HR=0.72, p<0.05
A: Pertuzumab+Trastuzumab+chemo (CF/CX)
17.5 vs 14.2
B: Trastuzumab+chemo (CF/CX)
HR=0.84, p=0.057 (failed)
CF, cisplatin and fluorouracil; CX, cisplatin and capecitabine; DOR, duration of response; G/GEJ, gastric/gastroesophageal junction; HR, hazard ratio; IA, interim analysis; ITT, intention-to-treat; m,
median; NA, not available; NR, not reached; OS, overall survival; Pembro, pembrolizumab; PFS, progression-free survival; Tras, trastuzumab; XELOX, capecitabine and oxaliplatin. 1. Janjigian YY,
et al. Lancet 2023; 402 (10418): 2197-2208. 2. Bang Y-J, et al. Lancet 2010; 376 (9742): 687-97. 3. Shen L, et al. Zhonghua Zhong Liu Za Zhi 2013; 35 (4): 295-300. 4. Tabernero J, et al. Lancet
Oncol 2018: 19 (10): 1372-1384.
Pertuzumab
28
JACOB4
(Ph III failed)
36 vs 48
ITT population
388 vs 392
© 2024 Henlius.
mDOR (months)
12.4 vs NR vs 6.8
A vs C: HR=0.6, p=0.2848
B vs C: HR=0.1, p=0.0006
IA2: 11.2 vs 9.0
HR NA, p NA
IA2: 11.3 vs 9.5
HR NA, p NA
IA2: 8.9 vs 9.0
HR NA, p NA
6.9 vs 4.8
HR=0.54, p <0.0001
5.8 vs 4.5
HR=0.56, p NA
10.2 vs 8.4
HR NA, p NA
2 HenliusView entire presentation