Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that PD-L1 (TAP) >= 5% status confers therapeutic sensitivity to Cisplatin, Fluorouracil, Tislelizumab in patients with Adenocarcinoma of the Gastroesophageal Junction.
The European Medicines Agency (EMA) has authorized tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express PD-L1 with a tumor area positivity (TAP) score >= 5%. This indication is based on BGB-A317-305, a global, randomized, double-blind, placebo-controlled study involving 997 patients. The chemotherapy regimen consisted of either oxaliplatin and capecitabine, or cisplatin and 5-FU.
This statement is based on a regulatory approval from the European Medicines Agency:
Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score >= 5%.
Citation
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2025-09-05 | Van Allen lab | On 2024-12-19, the EMA published an EPAR - Assessment report - Variation for Tevimbra (tislelizumab) that added an extension indication to tislelizumab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) whose tumours express PD-L1 with a tumor area positivity (TAP) score >= 5%. |
| 2024-11-25 | European Medicines Agency | Indication received approval from the European Commission. |