Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-negative, PD-L1 (CPS) >= 5 status confers therapeutic sensitivity to Nivolumab, Oxaliplatin in patients with Adenocarcinoma of the Gastroesophageal Junction.
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 (oxaliplatin).
This statement is based on a regulatory approval from the European Medicines Agency:
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) >= 5.