Astellas Pharma has received China’s National Medical Products Administration (NMPA) approval for Vyloy (zolbetuximab) to treat advanced gastric cancer.

Vyloy has been approved in combination with chemotherapy for first-line use in patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The approval specifically targets tumours that are claudin (CLDN) 18.2 positive.

Zolbetuximab, a monoclonal antibody, is said to be the first monoclonal antibody approved by NMPA for this purpose.

The NMPA’s approval is based on positive results from the global Phase 3 GLOW and SPOTLIGHT clinical trials, which included 145 and 36 patients from mainland China, respectively.

The GLOW trial compared zolbetuximab plus CAPOX (capecitabine and oxaliplatin) with a placebo plus CAPOX, while the SPOTLIGHT trial compared Vyloy plus mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) with a placebo plus mFOLFOX6.  

Zolbetuximab demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) compared to standard-of-care chemotherapies in eligible patients with gastric and GEJ cancers.

In the GLOW trial, median PFS was 8.21 months with zolbetuximab plus CAPOX versus 6.8 months with placebo. The median OS was 14.39 months versus 12.16 months.

In SPOTLIGHT, the median PFS was 10.61 months with Vyloy plus mFOLFOX6 versus 8.67 months with placebo, and the median OS was 18.23 months versus 15.54 months.  

Astellas Pharma immuno-oncology development senior vice president and head 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.”

Zolbetuximab received approval from the US Food and Drug Administration (FDA) in October last year for gastric or GEJ adenocarcinoma. It has also secured approval in Japan, the UK, South Korea, the US, Canada, Brazil, China, and the European Union.

An expanded Phase 2 trial of Vyloy is underway, involving 393 patients with metastatic pancreatic adenocarcinoma.  

The trial is evaluating zolbetuximab combined with gemcitabine and nab-paclitaxel for first-line treatment in CLDN18.2-positive tumours.

Additionally, ASP2138, a bispecific monoclonal antibody targeting CD3 and CLDN18.2, is in a Phase 1/1b study for gastric, GEJ, and pancreatic adenocarcinomas.