Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that CLDN18.2 >= 75%, HER2-negative status confers therapeutic sensitivity to Capecitabine, Oxaliplatin, Zolbetuximab in patients with Adenocarcinoma of the Gastroesophageal Junction.
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).
This statement is based on a regulatory approval from the Food and Drug Administration:
VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated 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.