Zolbetuximab and Chemotherapy Combination Demonstrates Positive Results for Some Patients with Gastric Cancers, According to Results from Phase 3 Trial

The combination met its main goal of progression-free survival and secondary goal of overall survival.

Zolbetuximab in combination with a chemotherapy regimen including capecitabine and oxaliplatin (CAPOX) demonstrated positive results in patients with HER2-negative locally advanced unresectable or metastatic gastric and gastroesophageal junction cancers, according to results of GLOW, a phase 3 clinical trial.

Specifically, the combination met the GLOW study’s main goal and secondary goal of progression-free survival (time during and after treatment when the patient lives without disease progression) and overall survival (time from diagnosis or treatment start when patients are alive), compared to that of patients treated with the placebo plus CAPOX. The most common side effects of the zolbetuximab plus CAPOX combination included nausea and vomiting.

“Zolbetuximab has the potential to be an innovative therapeutic option for patients with locally advanced unresectable or metastatic gastric or (gastroesophageal junction) cancer, a difficult disease for which treatment options are still limited,” said Dr. Ruihua Xu, primary investigator for the GLOW study and professor in the department of medical oncology at Sun Yat-Sen University Cancer Center in Guangzhou, China, in a press release. “I am so pleased with the topline results from GLOW that establish progression-free survival and overall survival in patients treated with zolbetuximab plus CAPOX.”

Of note, gastric cancer is often diagnosed in the advanced or metastatic stage with a five-year survival rate of 6% for most patients.

Zolbetuximab is an investigational first-in-class Claudin-18.2 (CLDN18.2) targeted monoclonal antibody that works by binding to CLDN18.2 on the cancer cells. Based on this and previous studies, approximately 38% of patients have CLDN18.2 positive tumors that meet the qualification of being expressed in at least 75% or more of tumor cells.

“… This further confirms the potential role of zolbetuximab in gastric cancer treatment, an important milestone in our gastric cancer development program,” said Dr. Ahsan Arozullah, senior vice president and head of development therapeutic areas at Astellas, the drug’s manufacturer, in the release. “We intend to discuss these results with regulatory authorities as we continue to develop zolbetuximab for the first-line treatment of patients with locally advanced unresectable or metastatic gastric and (gastroesophageal junction) cancer.”

Further detailed results will be presented at an upcoming scientific congress and will be submitted for publication.

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