^
Association details:
| Biomarker: | TMB-H |
|---|---|
| Cancer: | Gastric Cancer |
| Drug: | Loqtorzi (toripalimab-tpzi) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers
Excerpt:
...Previous tumor samples or fresh tumor tissue biopsy samples can be provided, and any of the following biomarkers are confirmed positive by the central laboratory: 1)PD-L1 positive: defined as PD-L1 staining positive at any intensity in ≥5% tumor cells (TC) or ≥10% immune cells (IC); 2)Epstein-Barr virus (EBV) positive: defined as positive for EBV-encoded small RNA in situ hybridization (EBER-ISH); 3)Tumor mutation burden-high (TMB-H): tumor tissues will be detected by whole exome sequencing (WES), with tumor mutation burden ≥12 Muts/Mb; 4)Microsatellite instability-high (MSI-H): Tumor tissue is tested by whole exome sequencing (WES) to confirm MSI-H positivity; 6....
Trial ID:
Source:
Title:
Tumor mutational burden identifies chemorefractory gastric cancer with overall survival advantage after receiving toripalimab, a PD-1 antibody.
Excerpt:
The TMB-high subgroup showed significant superior OS than the TMB-low subgroup (HR = 0.48 [96% CI 0.24 to 0.96], p = 0.038), while PD-L1 expression status failed to differentiate OS.
DOI:
10.1200/JCO.2019.37.15_suppl.4021
Trial ID:
Source:
Title:
Safety, efficacy and tumor mutational burden as a biomarker of overall survival benefit in chemo-refractory gastric cancer treated with toripalimab, a PD-1 antibody in phase Ib/II clinical trial NCT02915432
Excerpt:
The TMB-H group showed significant superior OS than the TMB-L group [14.6 versus 4.0 months, HR = 0.48 (96% CI 0.24-0.96), P = 0.038]...Toripalimab has demonstrated a manageable safety profile and promising antitumor activity in AGC patients, especially in combination with XELOX.
Secondary therapy:
CAPOX
DOI:
10.1093/annonc/mdz197
Trial ID:
