Astellas Pharma has reported that the Phase III GLOW clinical trial of zolbetuximab plus CAPOX as a first-line therapy to treat Claudin 18.2 (CLDN18.2)-positive, HER2-negative, locally advanced, unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancers met the primary endpoint.
The international, double-blind, multicentre, randomised trial was designed to analyse the safety and efficacy of zolbetuximab a versus placebo, along with CAPOX.
According to the positive topline data, the trial met the primary endpoint demonstrating statistically significant progression-free survival (PFS) in zolbetuximab plus CAPOX treated subjects, versus a placebo plus CAPOX.
A statistically significant overall survival (OS), meeting a crucial secondary endpoint, was seen in zolbetuximab-treated patients versus a placebo.
Nausea and vomiting were reported to be the most prevalent treatment-emergent adverse events (TEAEs) in the trial.
An investigational monoclonal antibody, Zolbetuximab works by attaching to CLDN18.2 seen on the cancer cell surface of gastric epithelial cells.
A combination chemotherapy regimen, CAPOX comprises capecitabine and oxaliplatin.
Astellas Development Therapeutic Areas senior vice-president and head Ahsan Arozullah said: “We are extremely pleased to share positive topline results from GLOW following the positive SPOTLIGHT readout last month.
“This further confirms the potential role of zolbetuximab in gastric cancer treatment, an important milestone in our gastric cancer development programme.
“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 GEJ cancer.”
This study, along with the Phase III SPOTLIGHT trial of zolbetuximab plus oxaliplatin, leucovorin and fluorouracil (mFOLFOX6), was carried out to offer foundational data for filing submissions to the regulatory authorities in the US, Europe, and Asia, among others.
In September this year, the company reported topline data from the Phase III MOONLIGHT 3 trial of fezolinetant for severe vasomotor symptoms linked to menopause in women in mainland China.