Therapeutic Response

PD-L1 (TAP) >= 5% status confers therapeutic sensitivity to Fluorouracil 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 FOLFOX-6 Modified Therapy. NCCP National SACT Regimen. HSE.

The Republic of Ireland's Health Service Executive (HSE) has approved tislelizumab in combination with FOLFOX-6 modified therapy (5-fluorouracil, folinic acid, 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.