CHMP endorses Astellas' zolbetuximab for advanced gastric cancer

Astellas’ zolbetuximab has received a favorable opinion from the European Medicines Agency’s human medicines committee for a specific group of patients with advanced gastric cancer. The Committee for Medicinal Products for Human Use (CHMP) has endorsed the use of the claudin (CLDN) 18.2-targeted monoclonal antibody. This protein is present on cancer cells and the recommendation includes administering it with fluoropyrimidine- and platinum-based chemotherapy. The treatment is aimed at adult patients with locally advanced, unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive.

Gastric cancer remains the sixth most common cause of cancer-related deaths in Europe, accounting for over 95,000 fatalities in 2022. The majority of these cases are adenocarcinomas, which originate from the cells lining the stomach’s innermost layer. Zolbetuximab, which was initially approved in Japan in March of this year, is developed to induce tumor cell death through mechanisms such as antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.

The CHMP’s recommendation is based on the findings from two phase 3 clinical trials named SPOTLIGHT and GLOW. These trials assessed the efficacy and safety of first-line treatment with zolbetuximab combined with chemotherapy in more than 1,000 adult patients. These patients had locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma with CLDN18.2 positive tumors. The results, published in Nature Medicine and The Lancet in 2023, demonstrated that the combination of zolbetuximab with chemotherapy regimens such as capecitabine and oxaliplatin (CAPOX) in the GLOW trial, and oxaliplatin, leucovorin, and fluorouracil (mFOLFOX6) in the SPOTLIGHT trial, led to a statistically significant improvement in both progression-free survival and overall survival when compared to a placebo combined with CAPOX or mFOLFOX6.

Dr. Moitreyee Chatterjee-Kishore, senior vice president and head of immuno-oncology development at Astellas, remarked on the positive CHMP opinion, “Zolbetuximab has the potential to become the first and only approved CLDN18.2 targeted treatment for patients with HER2-negative advanced gastric or GEJ cancers in the EU.”

This recommendation follows several other significant milestones for Astellas. Earlier in the year, their Pfizer-partnered drug Xtandi (enzalutamide) received approval from the European Commission (EC) for expanded use in prostate cancer treatment in April. More recently, the CHMP recommended Astellas and Pfizer’s Padcev (enfortumab vedotin) in combination with Merck & Co’s Keytruda (pembrolizumab) as a first-line treatment for advanced bladder cancer.

These developments underscore Astellas’ commitment to advancing oncology treatments and providing new therapeutic options for patients with difficult-to-treat cancers. With the positive CHMP opinion, zolbetuximab is poised to become a critical treatment option for patients battling advanced gastric or GEJ cancers, specifically those with CLDN18.2 positive tumors.

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