Investor Presentaiton
Clinical Data of HLX10-015-CRC301
Data cut-off date: 2023/06/01; median follow-up duration: 17.7 months
.
The latest clinical data of the phase II/III results (HLX10-015-CRC301) of HANSIZHUANG (HLX10, serplulimab)+HANBEITAI (HLX04, bevacizumab)+XELOX for 1L mCRC
(metastatic colorectal cancer) treatment was presented in posters at the 2024 ASCO GI
The results of this study demonstrated that serplulimab plus bevacizumab and XELOX was safe and markedly improved PFS and other efficacy endpoints compared to placebo
plus bevacizumab and XELOX in patients with mCRC. The probability of grade ≥3 treatment-related adverse events (AEs) of the two treatment groups were similar, with the most
common AEs are reduced neutrophil count and reduced platelet count
Serplulimab plus bevacizumab and XELOX warrants further large-scale investigation and could be a new1L treatment option for mCRC patients including MSS mCRC patients
Product
Clinical Trial
Regimen
Serplulimab+ HLX10-015-CRC301
A: Serplulimab+Bevacizumab+chemo
(XELOX)
SOC
(Ph II)
B: Bevacizumab+chemo (XELOX)
Sample Size
mPFS (months)
mOS (months)
mDOR (months)
ITT population
55 vs 57
17.2 vs 10.7
(extended 6.5 months)
HR=0.60, p=0.114
NR vs NR
HR=0.77, p=0.409
15.9 vs 12.6
HR=0.27, p=0.007
MSS subgroup
40 vs 50
ITT population
17.2 vs 10.1
(extended 7.1 months)
HR=0.58, p=0.110
NR vs NR
HR=0.67, p=0.293
15.9 vs 8.3
HR=0.36, p=0.023
ΝΑ
Atezolizumab
AtezoTRIBE1 (Ph II)
A: Atezolizumab+Bevacizumab+chemo
(FOLFOXIRI)
145 vs 73
13.1 vs 11.5
HR=0.71, p=0.015
+ SOC
B: Bevacizumab+chemo (FOLFOXIRI)
PMMR subgroup
134 vs 67
13.0 vs 11.5
HR=0.79, p=0.073
33 vs 27.2
HR=0.81, p=0.136
30.8 vs 26.9
HR=0.83, p=0.172
NA
Nivolumab+
CheckMate 9X82 (Ph II)
A: Nivolumab+Bevacizumab+chemo
(mFOLFOX6)
ITT population
SOC
127 vs 68
11.9 vs 11.9
HR=0.81, p=0.3 (negative)
29.2 vs NR
HR 1.03, p NA
12.9 vs 9.3
HR NA, p NA
B: Bevacizumab+chemo (mFOLFOX6)
for mCRC3 (Ph III)
Bevacizumab Bevacizumab+chemo (IFL*) A: Bevacizumab+chemo (IFL*)
(SOC)
B: chemo (IFL*)
ITT population
402 vs 411
10.6 vs 6.2
HR=0.54, p<0.001
20.3 vs 15.6
HR=0.66, p<0.001
10.4 vs 7.1
HR=0.62, p=0.001
* IFL, irinotecan, bolus fluorouracil, and leucovorin.
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1. J Clin Oncol 41, 2023 (suppl 16; abstr 3500). 2. Lenz, H-J. et al. J Clin Oncol 40, 4_suppl.008 (2022). 3. Hurwitz, H. et al. N Engl J Med 350, 2335-2342 (2004).
© 2024 Henlius.
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