Zolbetuximab regimen extends PFS in metastatic gastric, gastroesophageal junction cancers
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The addition of zolbetuximab to chemotherapy improved PFS among certain patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, 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 double-blind, randomized phase 3 GLOW trial assessed the efficacy and safety of zolbetuximab plus CAPOX— a combination chemotherapy regimen that includes capecitabine and oxaliplatin — as first-line treatment for patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Researchers randomly assigned 507 patients at 165 study locations to CAPOX plus either zolbetuximab or placebo.
Results showed a significant improvement in PFS — the study’s primary endpoint — with the zolbetuximab regimen. The study also met its secondary endpoint of improved OS.
“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,” Ruihua Xu, MD, PhD, primary investigator for the GLOW study and professor in the department of medical oncology at Sun Yat-Sen University Cancer Center in Guangzhou, China, said in an Astellas-issued 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.”
The most frequent treatment-emergent adverse events among zolbetuximab-treated patients included nausea and vomiting.
Complete data from the trial will be presented at a scientific congress.
The results of the GLOW trial follow results shared last month from the phase 3 SPOTLIGHT trial, which evaluated the efficacy and safety of modified FOLFOX6 — a combination chemotherapy regimen of oxaliplatin, leucovorin and fluorouracil — plus either placebo or zolbetuximab for a similar patient population.
“We are extremely pleased to share positive topline results from GLOW following the positive SPOTLIGHT readout last month,” Ahsan Arozullah, MD, MPH, senior vice president and head of development therapeutic areas with Astellas, said in the release. “This further confirms the potential role of zolbetuximab in gastric cancer treatment, an important milestone in our gastric cancer development program.”
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