Astellas’ zolbetuximab has received a positive opinion of approval from the European Medicines Agency’s human medicines committee in a subset of advanced gastric cancer patients.
The Committee for Medicinal Products for Human Use (CHMP) has recommended the claudin (CLDN) 18.2 – a transmembrane protein expressed on cancer cells – targeted monoclonal antibody for use alongside fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro oesophageal junction (GEJ) adenocarcinoma whose tumours are CLDN18.2 positive.
Currently the sixth most common cause of cancer-related mortality in Europe, gastric cancer was responsible for more than 95,000 deaths in 2022, of which adenocarcinomas, which form from cells in the innermost lining of the stomach, account for the majority of cases.
First approved in Japan earlier this year in March, zolbetuximab is designed to mediate tumour cell death through antibody-dependant cellular cytotoxicity and complement-dependant cytotoxicity.
The CHMP’s decision was based on results from the phase 3 SPOTLIGHT and GLOW clinical trials, which explored the efficacy and safety of first-line zolbetuximab treatment in combination with a chemotherapy regimen in more than 1,000 adult patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumours were CLDN18.2 positive.
Published in Nature Medicine and The Lancet in 2023, both trials showed that zolbetuximab plus a combination chemotherapy regimen including capecitabine and oxaliplatin (CAPOX) (GLOW) and including oxaliplatin, leucovorin and fluorouracil (mFOLFOX6) (SPOTLIGHT) demonstrated a statistically significant improvement in progression-free survival and overall survival compared to placebo plus CAPOX/mFOLFOX6.
Commenting on the positive CHMP opinion, Moitreyee Chatterjee-Kishore, senior vice president and head of immuno-oncology development, Astellas, said: “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.”
The recommendation comes a few months after Astellas announced that its Pfizer-partnered Xtandi (enzalutamide) received approval by the EC for expanded prostate cancer use in April.
Most recently, Astellas/Pfizer’s Padcev (enfortumab vedotin) was recommended by the CHMP in combination with Merck & Co’s Keytruda (pembrolizumab) as a first-line treatment for advanced bladder cancer.