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news.The China National Medical Products Administration (NMPA) has granted approval to Astellas Pharma’s VYLOY (zolbetuximab), a first-in-class monoclonal antibody, for use in conjunction with chemotherapy for the first-line treatment of individuals with a specific type of gastric cancer.
VYLOY is intended for first-line treatment of individuals with a specific type of gastric cancer. Credit: HansMartinPaul on Pixabay.
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This marks the first NMPA-approved monoclonal antibody that targets gastric tumour cells expressing the biomarker CLDN18.2.
The approval offers a new, highly targeted treatment option for individuals particularly with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with CLDN 18.2 positive tumours.
VYLOY’s approval is based on data from the global Phase III GLOW and SPOTLIGHT clinical trials, which included subjects from mainland China.
The GLOW trial demonstrated that zolbetuximab, in conjunction with CAPOX chemotherapy, significantly improved overall survival (OS) and progression-free survival (PFS) compared to the placebo group. Subjects receiving the therapy achieved a median PFS of 8.21 months and a median OS of 14.39 months, surpassing the placebo group’s results.
Similar outcomes were observed in the SPOTLIGHT trial, where subjects treated with the therapy along with mFOLFOX6 chemotherapy had a median PFS of 10.61 months and a median OS of 18.23 months.
In both trials, the incidence of serious treatment emergent adverse events (TEAEs) was comparable between the therapy treatment groups and the control groups.
Zolbetuximab is designed to specifically target claudin-18.2(CLDN18. 2), a transmembrane protein found on tumour cells.
Astellas Pharma Immuno-Oncology Development head and senior vice-president Moitreyee Chatterjee-Kishore said: “Approximately 35% of Chinese patients with advanced and metastatic gastric and GEJ cancers have tumours that positively express CLDN18.2.
“By specifically targeting this biomarker with zolbetuximab we are able to stimulate selective cell death, reducing the overall number of CLDN18.2-positive cells in a tumour. The NMPA approval of zolbetuximab offers a new precision medicine for first-line use in China, supporting our ongoing ambition to drive progress and innovation in cancer care.”
