Astellas Gains Positive CHMP Opinion for Zolbetuximab with Chemotherapy in Treating Advanced Gastric and Gastroesophageal Junction Cancer

Astellas Pharma Inc., a prominent pharmaceutical company, has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of zolbetuximab in the European Union. This announcement marks a significant milestone for zolbetuximab, a first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody. The drug is recommended in combination with fluoropyrimidine- and platinum-based chemotherapy for first-line treatment in adults with locally advanced, unresectable, or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that express CLDN18.2.

If zolbetuximab receives approval from the European Commission, it will be the first and only CLDN18.2-targeted therapy available in the European Union. A decision on this marketing authorization is anticipated by October 2024. Gastric cancer is a pressing health issue in Europe, being the sixth leading cause of cancer-related deaths, with over 95,000 fatalities in 2022 alone. The disease is often detected at an advanced stage due to its early symptoms mimicking common stomach issues, leading to a dire need for new treatments.

Moitreyee Chatterjee-Kishore, Ph.D., Senior Vice President and Head of Immuno-Oncology Development at Astellas, emphasized the critical need for new treatment options for the approximately 135,000 new gastric cancer cases diagnosed in Europe in 2022. Zolbetuximab is poised to address this need, potentially becoming the first approved treatment for patients with HER2-negative advanced gastric or GEJ cancers expressing CLDN18.2, reflecting Astellas' commitment to innovative therapeutic solutions.

The CHMP’s positive opinion is underpinned by findings from the Phase 3 SPOTLIGHT and GLOW clinical trials, which evaluated zolbetuximab's efficacy and safety in the specified patient group. These studies, published in The Lancet and Nature Medicine, respectively, identified CLDN18.2 positivity based on considerable immunohistochemical staining in at least 75% of tumor cells. Astellas partnered with Roche to develop the VENTANA® CLDN18 (43-14A) RxDx Assay, a diagnostic tool intended to aid in identifying patients suitable for zolbetuximab treatment, pending its approval.

Following the CHMP recommendation, the European Commission will review the application, with the authority to approve the therapy across the EU and in Iceland, Liechtenstein, and Norway. Additionally, Astellas has incorporated the expected impact of this potential approval into its financial forecasts for the fiscal year ending March 31, 2025. Beyond the EMA, Astellas has submitted zolbetuximab for review by other global regulatory bodies. Notably, Japan's Ministry of Health, Labour and Welfare (MHLW) approved zolbetuximab in March 2024, marking the first regulatory approval for a CLDN18.2-targeted treatment worldwide.

Zolbetuximab is a cytolytic antibody targeting CLDN18.2, which is present on cancer cells. Pre-clinical studies demonstrated that zolbetuximab could reduce CLDN18.2-positive cells, thereby inhibiting tumor growth through antibody-dependent and complement-dependent cytotoxicity mechanisms.

Gastric cancer remains a significant health concern globally, with over 135,000 new cases diagnosed in Europe in 2022 alone. This form of cancer is often diagnosed at an advanced stage due to non-specific early symptoms, such as indigestion and abdominal discomfort, complicating early detection and treatment efforts. Risk factors for gastric and GEJ cancers include older age, male gender, family history, H. pylori infection, smoking, and gastroesophageal reflux disease (GERD).

Astellas continues to advance its investigational pipeline with further studies on zolbetuximab and other promising agents like ASP2138, aimed at treating cancers expressing CLDN18.2. These efforts reflect Astellas’ dedication to developing novel treatments to meet unmet medical needs and improve patient outcomes.

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