An international phase 3 clinical trial, done in participation with Weill Cornell Medicine and NewYork-Presbyterian, has found that a new targeted treatment called zolbetuximab, given in combination with a standard chemotherapy, extended survival for patients with advanced gastric or gastroesophageal junction cancer that overexpressed a specific biomarker.
, together with results from the parallel SPOTLIGHT study that evaluated zolbetuximab with an alternative standard chemotherapy, prompted the United States Food and Drug Administration to grant priority review to the manufacturer's biologic license application and set January 12, 2024, as the target decision date.
Gastric cancer is the fifth most diagnosed cancer globally, and its incidence has increased markedly in the last few decades. Patients with cancer of the stomach or at the junction where the esophagus joins the stomach, known as the gastroesophageal junction, typically have few symptoms in early disease stages, so most are diagnosed after the cancer has advanced or become metastatic.
There is another group of HER2-negative patients who fit neither category, and for whom targeted therapies aren't generally used. However, these gastric cancers tend to have higher levels of CLDN 18.2, which is normally found in gastric mucosa cells and becomes more exposed asdevelops. Zolbetuximab is a monoclonal antibody, administered intravenously, that binds to CLDN18.2, killing the dividing cancer cells directly and also alerting the immune system to respond.
The GLOW study was conducted between November 2018 and February 2022 at 166 sites, including NewYork-Presbyterian/Weill Cornell Medical Center, across 18 countries. A total of 507 patients with previously untreated HER2-negative locally advanced or metastatic gastric or gastroesophageal junction cancer expressing CLDN18.2 were randomized to receive zolbetuximab in combination with capecitabine plus oxaliplatin chemotherapy or a placebo plus CAPOX.compared with placebo plus CAPOX.
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