An international phase 3 clinical trial, done in participation with Weill Cornell Medicine and NewYork-Presbyterian, 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.
Results from the GLOW study, published July 31 in Nature Medicine, 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.
There are few targeted treatments available for patients with gastric and gastroesophageal cancers: Patients with tumors expressing the programmed cell death ligand 1 protein can be treated with immunotherapy, and those with HER2-positive tumors can be treated with trastuzumab, also known by the trade name Herceptin. There is another group of HER2-negative patients who fit neither category, and for whom targeted therapies aren't generally used.
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.
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