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On August 18, 2021, Junshi Biosciences and Coherus Biosciences jointly announced that the pivotal phase 3 clinical trial named "CHOICE-01" has achieved positive interim results
.
The trial aims to evaluate the efficacy of toripalimab combined with chemotherapy drugs developed by Junshi Biotechnology in the first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC)
Teriprolizumab is a recombinant humanized anti-PD-1 monoclonal antibody
.
PD-1 is an immune checkpoint receptor on the surface of lymphocytes.
The randomized, double-blind, placebo-controlled phase 3 clinical trial of CHOICE-01 enrolled 465 patients with newly treated advanced squamous (n=220) or non-squamous (n=245) NSCLC
.
The main interim analysis results of the trial are as follows:
Compared with the placebo group, the teriprolizumab group showed a clinically significant and statistically significant improvement in PFS [HR=0.
58, (95% CI: 0.
44-0.
77), P=0.
0001], the median PFS was 8.
3 vs.
5.
6 months
.
The 1-year PFS rates of the teriprizumab group and the placebo group were 32.
Regardless of whether the tumor cells express PD-L1, improvement of PFS was observed in both squamous [HR=0.
55 (95% CI: 0.
38-0.
83)] and non-squamous [HR=0.
59 (95% CI: 0.
40-0.
87)] NSCLC patients
.
Compared with the placebo group, the teriplimumab group showed an improved objective response rate (ORR) (squamous NSCLC: 68.
7% vs.
58.
9%; non-squamous NSCLC: 58.
6% vs.
26.
5%) and a median response rate Duration (DoR) (squamous NSCLC: 6.
9 months vs.
4.
2 months; non-squamous NSCLC: 8.
6 months vs.
5.
1 months)
.
The overall survival data is not yet mature, but there is a trend to support the teriplimumab group.
Compared with the placebo group (16 months), the median overall survival (OS) is 21.
0 months [HR=0.
81 (95 % CI: 0.
57-1.
17)]
.
In terms of safety, teriprizumab combined with standard chemotherapy in the first-line treatment of patients with advanced NSCLC showed manageable safety characteristics, and no new safety signals were observed
.
The incidence of grade ≥3 adverse events (AE) in the teriprizumab group and placebo group was 76.
Reference materials:
[1] Junshi and Coherus Biosciences Announce Positive Interim Results of CHOICE-01, a Phase 3 Clinical Trial Evaluating Teriplimumab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer.