Astellas Pharma's CLDN18.2 Monoclonal Antibody Vyloy (Zolbetuximab) Approved in South Korea for Gastric Cancer Treatment

Sep 24, 2024 09:12 CST Updated 09:12

Astellas

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September 23,Astellas（Astellas Pharma）South Korean Company Announces MFDS Approval for Vyloy (zolbetuximab)For the treatment of advanced gastric and gastroesophageal junction (GEJ) adenocarcinomaAccording to the Astellas press release,zolbetuximabIs aAn antibody targeting Claudin18.2 (CLDN18.2), alsoThe world's first approved targeted Claudin 18.2 therapeutic drug, applicable to patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who are Claudin 18.2-positive and HER2-negative.

Zolbetuximab is a "first-in-class" monoclonal antibody targeting CLDN18.2. It was approved by Japan's Ministry of Health, Labour and Welfare (MHLW) in March 2024, becoming the world's first CLDN18.2-targeted treatment to receive regulatory approval.

The approval and market launch of this product in South Korea are based on the results of the SPOTLIGHT and GLOW Phase 3 trials. In the SPOTLIGHT trial, the median progression-free survival (PFS) in the Vyloy group was...PFS）The median progression-free survival (PFS) was 10.61 months in the Vyloy group and 8.67 months in the placebo group; the median overall survival (OS) was 18.23 months in the Vyloy group and 15.54 months in the placebo group.GLOW study showed similar results, with a median PFS of 8.21 months in the Vyloy group and 6.80 months in the placebo group.The median OS in the Vyloy group was 14.39 months, compared to 12.16 months in the placebo group.

In addition, Asian patients showed more significant benefits in both trials. In the SPOTLIGHT study, the Vyloy groupThe median PFS for Asian patients was 13.96 months, and the median OS was 23.33 months., significantly longer than the non-Asian group's 8.94-month PFS and 16.13-month OS. The GLOW trial also confirmed these findings,The median PFS for Asian patients was 8.44 months, and the OS was 15.47 months., while the median PFS for non-Asian patients was 7.98 months and OS was 13.27 months.

In China, zolbetuximab (Zolbetuximab for Injection)Marketing ApplicationAccepted by the National Medical Products Administration (NMPA) of China in August 2023,Used forFirst-line treatment for CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients。

References:

[1]Astellas Korea wins approval for Claudin 18.2-targeted gastric cancer therapy.Retrieved Sep 23，2024, From https://www.koreabiomed.com/news/articleView.html?idxno=25188

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