Therapeutic Response

CLDN18.2 >= 75% and HER2-negative status confers therapeutic sensitivity to Fluorouracil in combination with Oxaliplatin and Zolbetuximab in patients with Adenocarcinoma of the Gastroesophageal Junction.

Statements

Source and description
Vyloy (zolbetuximab) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted approval to zolbetuximab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive, as determined by an FDA-approved test. The package insert states that that eligible patients should have CLDN18.2 positive tumors, defined as >= 75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining. The package insert 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).
Vyloy (zolbetuximab) [product information]. EMA. 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).