Zolbetuximab regimen extends PFS in metastatic gastric, gastroesophageal junction cancers
The addition of zolbetuximab to chemotherapy improved PFS among certain patients with gastric or gastroesophageal junction cancers, according to the agent’s manufacturer.
Zolbetuximab (IMAB362, Astellas) is an investigational chimeric IgG1 monoclonal antibody that targets and binds to Claudin 18.2 (CLDN18.2).
The randomized phase 3 SPOTLIGHT trial assessed the efficacy and safety of zolbetuximab plus modified FOLFOX6 — a chemotherapy regimen that includes oxaliplatin, leucovorin and fluorouracil — as first-line treatment for patients with CLDN18.2-positive, HER2-negative locally advanced or metastatic gastric or gastroesophageal junction cancers.
Researchers randomly assigned 566 patients to modified FOLFOX6 plus either zolbetuximab or placebo.
Results showed a statistically significant improvement in PFS — the study’s primary endpoint — with the zolbetuximab regimen. The study also met a secondary endpoint, showing improved OS with zolbetuximab.
“I am excited by the potential for a new treatment option to help patients with advanced-stage gastric cancer or [gastroesophageal junction] cancer," Kohei Shitara, MD, primary investigator for the SPOTLIGHT trial and chief of the department of gastrointestinal oncology at National Cancer Center Hospital East in Japan, said in an Astellas-issued press release. "Gastric and [gastroesophageal junction] cancers still have very limited treatment options available for patients with an advanced diagnosis."
The most frequent treatment-emergent adverse events among zolbetuximab-treated patients included nausea, vomiting and decreased appetite.
The double-blind SPOTLIGHT trial took place at 220 sites in the United States, Europe, Australia, South America and Asia. Full data will be presented at a scientific congress.
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