▎WuXiEdited by Kant Content Team

Astellas Pharma today announced,The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of zolbetuximab in combination with fluorouracil-containing or platinum-containing chemotherapy for first-line treatment of adult patients with CLDN18.2-positive, locally advanced unresectable or metastatic HER2-negative gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma in the EU.The press release noted that if approved, zolbetuximab will become the first treatment targeting CLDN18.2 to be approved in the EU.

Results from the SPOTLIGHT trial, published in January of last year, showed that patients treated with zolbetuximab in combination with chemotherapy had significant improvements in progression-free survival (PFS) and overall survival (OS) compared to those receiving a placebo plus chemotherapy containing fluorouracil.Compared with the placebo group, the risk of disease progression and death in the experimental group was significantly reduced by 24.9%, achieving the primary endpoint of the trial.Patients treated with zolbetuximab combination therapy had a median progression-free survival of 10.61 months (8.67 months in the control group) and an extended overall survival, with a median overall survival of 18.23 months (15.54 months in the control group).

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The results of the GLOW trial, published in March last year, showed that patients treated with zolbetuximab in combination with platinum-based chemotherapy had significantly improved PFS compared to those receiving placebo and platinum-based chemotherapy.Compared with the placebo group, the combination therapy reduced the risk of disease progression or death by 31.3% in patients, with a PFS of 8.21 months in the experimental group (6.80 months in the control group).Moreover, the combination therapy significantly prolonged patients' OS, reducing the risk of death by 22.9%. The median survival time for patients in the experimental group was 14.39 months (12.16 months for the control group).

Zolbetuximab is a "first-in-class" monoclonal antibody targeting CLDN18.2. It was approved by Japan's Ministry of Health, Labour and Welfare (MHLW) in March 2024, becoming the world's first CLDN18.2-targeted treatment to receive regulatory approval.

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