Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that CLDN18.2 >= 75%, HER2-negative status confers therapeutic sensitivity to Fluorouracil, Oxaliplatin, Zolbetuximab in patients with Adenocarcinoma of the Gastroesophageal Junction.
The European Medicines Agency (EMA) has authorized zolbetuximab in combination with fluoropyrimidine- and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocracinoma whose tumors are Claudin (CLDN) 18.2 positive. The product information states that eligible patients should have CLDN18.2 positive tumor defined as >= 75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed by a CE-marked IVD with the corresponding intended purpose. The product information further states that this indication is based on Spotlight (8951-CL-0301) and Glow (8951-CL-0302), both phase 3, double-blind, randomized, multicenter studies that enrolled 1072 patients where the choice of either mFOLFOX6 (oxaliplatin, folinic acid, and fluorouracil) or CAPOX (oxaliplatin and capecitabine).
This statement is based on a regulatory approval from the European Medicines Agency:
Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive.