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.
This statement is based on a regulatory approval from the Health Canada:
Vyloy (zolbetuximab for injection), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive as determined by a validated test.