Therapeutic Response

PD-L1 (TAP) >= 5% status confers therapeutic sensitivity to Capecitabine in combination with Oxaliplatin and Tislelizumab in patients with Esophageal Squamous Cell Carcinoma.

Statements

Source and description
Tevimbra (tislelizumab) [product information]. EMA.

The European Medicines Agency (EMA) has authorized 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%. This indication is based on BGB-A317-306, a multi-regional, randomized, placebo-controlled, double-blind phase 3 study. The chemotherapy doublet regimen consisted of: cisplatin and 5-FU; cisplatin and capecitabine; oxaliplatin and 5-FU; oxaliplatin and capecitabine; cisplatin and paclitaxel; or oxaliplatin and paclitaxel.
Tislelizumab and CAPOX Therapy. NCCP National SACT Regimen. HSE.

The Republic of Ireland's Health Service Executive (HSE) has approved tislelizumab in combination with CAPOX (capecitabine and oxaliplatin) as a treatment option for the first-line treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express programmed death-ligand (PD-L1) with a tumor area positivity (TAP) score >= 5%. The treatment regimen further states that, as the platinum and fluoropyrimidine based chemotherapy is not defined in the EMA licensed indication, other evidence-based platinum and fluoropyrimidine regimens may be used in combination with tislelizumab.