Astellas Submits NDA For Zolbetuximab In Japan For Advanced Gastric, Gastroesophageal Cancers

(RTTNews) - Astellas Pharma Inc. (ALPMY) announced Friday the submission of a New Drug Application or NDA to Japan's Ministry of Health, Labour and Welfare or MHLW for zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers.

If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.

The company noted that gastric cancer, also commonly known as stomach cancer, is the fifth most commonly diagnosed cancer worldwide.

zolbetuximab is for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive.

Zolbetuximab is an investigational, first-in-class chimeric IgG1 monoclonal antibody (mAb) that targets and binds to CLDN18.2, a transmembrane protein. It acts by binding to CLDN18.2 on the cancer cell surface of gastric epithelial cells.

The NDA is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6.

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

In both trials, around 38% of patients screened for the trials had tumors that were CLDN18.2-positive, as determined by a validated immunohistochemistry assay.

Pranob Bhattacharya, Executive Director and Interim Head of Immuno-Oncology Development, Astellas, said, "Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer. Astellas' submission of a New Drug Application to Japan's Ministry of Health, Labour and Welfare for zolbetuximab demonstrates critical momentum in addressing the unmet needs of patients with gastric cancer in Japan."

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