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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Esophageal Squamous Cell Carcinoma |
| Drug: | Hetronifly (serplulimab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC
Published date:
09/22/2023
Excerpt:
Shanghai Henlius Biotech, Inc...announced...HANSIZHUANG (serplulimab injection), an innovative anti-PD-1 monoclonal antibody independently developed by the company, in combination with drugs containing fluorouracil and platinum for the first-line treatment of patients with PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC), has been approved by the National Medical Products Administration (the "NMPA"), providing a new treatment option for patients with ESCC.
Secondary therapy:
5-fluorouracil
Source:
Title:
Updated results of first-line serplulimab versus placebo plus chemotherapy in PD-L1–positive esophageal squamous cell carcinoma: A randomized, double-blind, multicenter phase 3 study (ASTRUM-007).
Published date:
05/25/2023
Excerpt:
In this randomized, double-blind, multicenter phase 3 study, patients with...PD-L1–positive ESCC who had no prior systemic antitumor therapy were randomized 2:1 to receive serplulimab 3 mg/kg or placebo plus chemo (5-FU + cisplatin)....Median OS was significantly longer in the serplulimab-chemo group than the placebo-chemo group (14.6 vs 11.2 months; hazard ratio [HR] 0.70, 95% CI 0.57–0.86; P = 0.0006)....Efficacy improvements were also observed in confirmed objective response rate (58.7% vs 42.1%) and duration of response (median, 7.1 vs 4.6 months)....With another 9.3 months of follow-up, the encouraging efficacy and manageable safety of serplulimab plus chemo as first-line treatment in patients with PD-L1–positive advanced ESCC were maintained...
Secondary therapy:
cisplatin + 5-fluorouracil
DOI:
10.1200/JCO.2023.41.16_suppl.e16016
Trial ID:
Source:
Title:
First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial
Published date:
02/02/2023
Excerpt:
At the prespecified interim analysis of overall survival (OS), serplulimab plus chemotherapy also significantly prolonged OS compared with placebo plus chemotherapy (median OS of 15.3 months and 11.8 months, respectively; hazard ratio, 0.68; 95% confidence interval, 0.53-0.87; P = 0.0020)...Serplulimab plus chemotherapy administered every 2 weeks significantly improved PFS and OS in patients with previously untreated, PD-L1-positive advanced ESCC, with a manageable safety profile.
Secondary therapy:
Chemotherapy
DOI:
10.1038/s41591-022-02179-2
Trial ID:
Source:
Title:
69O - First-line serplulimab versus placebo in combination with chemotherapy in PD-L1-positive oesophageal squamous cell carcinoma (ASTRUM-007): A randomised, double-blind, multicentre phase III study
Published date:
11/28/2022
Excerpt:
Median PFS (final analysis) was significantly longer in serplulimab plus chemo group (5.8 months [95% CI 5.7–6.9]) than that in placebo plus chemo group (5.3 months [95% CI 4.3–5.6]; HR 0.60, 95% CI 0.48–0.75; p<0.0001). Median OS (interim analysis) was also significantly improved with the addition of serplulimab (15.3 months [95% CI 14.0–18.6] versus 11.8 months [95% CI 9.7–14.0]; HR 0.68, 95% CI 0.53–0.87; p=0.0020)....Serplulimab in combination with chemo administered every 2 weeks significantly improved PFS (final) and OS (interim) compared with chemo alone in first-line therapy of PD-L1-positive advanced ESCC...
Secondary therapy:
Chemotherapy
Trial ID:
Source:
Title:
A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Excerpt:
...- PD-L1 positive subjects (CPS 1%).The subject must provide tumor tissue for pd-l1 expression level determination;...
Trial ID:
