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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Gastroesophageal Junction Adenocarcinoma |
| Drug: | Tyvyt (sintilimab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer
Published date:
12/05/2023
Excerpt:
Among patients with unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma treated with first-line chemotherapy, sintilimab significantly improved overall survival for all patients and for patients with a CPS of 5 or more compared with placebo.
Secondary therapy:
capecitabine + oxaliplatin
DOI:
10.1001/jama.2023.19918
Trial ID:
Source:
Title:
LBA53 - Sintilimab plus chemotherapy (chemo) versus chemo as first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16): First results of a randomized, double-blind, phase III study
Published date:
09/13/2021
Excerpt:
S+C showed a significant improvement in OS vs C in pts with CPS≥5...PFS was superior with S+C vs C in pts with CPS≥5...nconfirmed ORR were 72.8% vs 59.6% in pts with CPS≥5 and 65.1% vs 58.7% in all pts with measurable disease, with a median DOR of 8.4 vs 5.5 and 8.6 vs 5.5 months, respectively.
Secondary therapy:
Chemotherapy
Trial ID:
Source:
Title:
Innovent Announces Sintilimab in Combination with Chemotherapy Meets the Primary Endpoint of Overall Survival in the Phase 3 ORIENT-16 Study for the First-Line Treatment of Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Published date:
08/15/2021
Excerpt:
Innovent Biologics, Inc....today announced that the sintilimab Phase 3 ORIENT-16 study met its predefined primary endpoint of overall survival (OS)....In an interim analysis, sintilimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint of OS compared to placebo plus chemotherapy, in both the intention-to-treat (ITT) group and PD-L1 positive group.
Secondary therapy:
capecitabine + oxaliplatin
Trial ID:
Source:
Title:
Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer
Excerpt:
...Overall survival (OS)of Sintilimab in combination with oxaliplatin + fluoropyrimidine versus placebo+oxaliplatin + fluoropyrimidine in all randomized participants;Overall survival(OS) of Sintilimab + oxaliplatin + capecitabine versus placebo+ oxaliplatin + capecitabine in participants with programmed cell death ligand 1 (PD-L1) expressing tumors (CPS>=10)`Overall survival (OS)...
Trial ID:
Source:
Title:
784 Biomarkers of perioperative immunotherapy in combination with concurrent chemoradiotherapy for locally advanced gastric or gastroesophageal junction adenocarcinoma
Published date:
11/04/2023
Excerpt:
34 patients with locally advanced G/GEJ cancer received anti-PD-1 therapy (Sintilimab)...Our results met the pre-specified primary endpoint, with a pCR rate of 38.2% and median DFS of 17.0 months. Tumor mutation burden (TMB) analyzed by NGS was significantly higher in the pCR group than those not achieving pCR (non-pCR)...Biomarker analysis by mIF showed patients with positive PD-L1 expression showed a numerically higher pCR rate...positive PD-L1 expression, higher T cell infiltration and TMB could be predictive biomarkers of perioperative anti-PD-1 therapy in combination with cCRT for locally advanced G/GEJ.
DOI:
10.1136/jitc-2023-SITC2023.0784
Trial ID:
