Therapeutic Response

HER2-negative and PD-L1 (CPS) >= 5 status confers therapeutic sensitivity to Fluorouracil in combination with Nivolumab and Oxaliplatin in patients with Stomach Adenocarcinoma.

Statements

Source and description
Opdivo (nivolumab) [product information]. EMA. The European Medicines Agency (EMA) has authorized nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-esophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 5. This indication is based on CA209649, a phase 3, randomized, open-label study where the choice of chemotherapy was FOLFOX (oxaliplatin, leucovorin, and fluorouracil) or CapeOX (capecitabine and oxaliplatin).
Nivolumab and FOLFOX-6 Modified Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for reimbursement as a treatment option for the first-line treatment of adult patients with HER-2 negative advanced or metastatic gastric (GC), gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), whose tumours express PD-L1 (CPS) >= 5. This regimen specifically cites FOLFOX-6 modified therapy as the chemotherapy. It also notes 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 nivolumab.