Japan becomes first country to approve Astellas’ gastric cancer mAb

Japanese flag

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Vyloy (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer.

Vyloy is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world.

Gastric cancer is the third deadliest cancer in Japan, with 126,724 cases diagnosed in 2022.

Kohei Shitara, Primary Investigator for the SPOTLIGHT Trial and Head, Department of Gastrointestinal Oncology, the National Cancer Center Hospital East in Kashiwa, Japan, said: “Developing new targeted therapies is critical for diseases like advanced gastric adenocarcinoma, which has had very limited treatment options and is often discovered at an advanced stage.

“As the primary investigator for the Phase III SPOTLIGHT clinical trial, I witnessed firsthand the significant improvement in progression-free survival and overall survival for patients treated with Vyloy in combination with chemotherapy compared to those treated with placebo plus chemotherapy. These results support Vyloy as a new treatment option for the CLDN18.2-positive population in Japan.”

Gastric cancer clinical trial results

The approval is based on results from the Phase III SPOTLIGHT and GLOW clinical trials for first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours were CLDN18.2 positive.

The SPOTLIGHT study evaluated Vyloy plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6.

The GLOW study evaluated Vyloy plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

Both trials met their primary endpoint, progression-free survival (PFS), as well as a key secondary endpoint, overall survival (OS), showing statistical significance in patients treated with Vyloy plus chemotherapy compared to placebo plus chemotherapy.

Moitreyee Chatterjee-Kishore, Senior Vice President and Head of Immuno-Oncology Development, Astellas, said: “The approval of Vyloy by the MHLW marks a new era in the treatment of gastric cancer, offering the first and only targeted therapy option for CLDN18.2-positive patients living with this devastating disease. Astellas is proud to help address the urgent therapeutic need for this hard-to-treat cancer in Japan, where incidence rates are among the highest globally.”

Diana Spencer, Senior Digital Content Editor, DDW

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