Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 (TAP) >= 1% status confers therapeutic sensitivity to Fluorouracil, Oxaliplatin, Tislelizumab in patients with Esophageal Squamous Cell Carcinoma.
The U.S. Food and Drug Administration (FDA) granted approval to tislelizumab in combination with platinum-containing chemotherapy for the first-line treatment of adult patients unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (>=1). This indication is based on RATIONALE-306 (NCT03783442), a global, randomized, placebo-controlled, double-blind study. PD-L1 status was assessed using an assay that reported Tumor Area Positivity (TAP), though a retrospective scoring of tumor PD-L1 status using Combined Positive Score (CPS) was also conducted. Chemotherapy regimens consisted of tevimbra in combination with either: cisplatin and fluoropyrimidine, cisplatin and capecitabine, oxaliplatin and fluoropyrimidine, oxaplatin and capecitabine, cisplatin and paclitaxel, or oxaliplatin and paclitaxel.
This statement is based on a regulatory approval from the Food and Drug Administration:
TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (>=1).