Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 (TAP) >= 5% status confers therapeutic sensitivity to Capecitabine, Oxaliplatin, 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%.