TOKYO, April 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that The Lancet published detailed data from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin 18.2 (CLDN18.2) targeted monoclonal antibody, plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study data was first published online on April 14 in The Lancet.1 Initial results from SPOTLIGHT, which met its primary endpoint of progression-free survival (PFS) and a key secondary endpoint of overall survival (OS), were presented at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium.

“Patients with HER2-negative, CLDN18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancers have limited first-line treatments available that are biomarker-based,” said Kohei Shitara, MD, Primary Investigator for the SPOTLIGHT trial and Head, Department of Gastrointestinal Oncology, the National Cancer Center Hospital East in Kashiwa, Japan. “The Lancet’s decision to publish the SPOTLIGHT study reinforces the value this data provides to the gastrointestinal cancer scientific community.”

“The publication of the SPOTLIGHT study is an important report of the first Phase 3 trial to demonstrate clinical benefit following CLDN18.2-targeted therapy in any tumor type, and we are honored that it has been published in The Lancet,” said Pranob Bhattacharya, DrPH, MS, MBA, Executive Director and Interim Head of Immuno-oncology, Astellas. “This manuscript, which provides further insight into the investigational use of zolbetuximab, reinforces Astellas’ commitment to patients with advanced-stage gastric/GEJ cancer.”

The SPOTLIGHT and GLOW studies are part of Astellas’ gastric cancer development program to investigate targeted treatment options, such as zolbetuximab, and address patient needs in locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. These two statistically significant Phase 3 trials will serve as the basis for global regulatory submissions. In both trials, approximately 38% of these patients had CLDN18.2-positive tumors (≥75% of tumor cells with strong-to-moderate membranous CLDN18 staining intensity), as determined by a validated immunohistochemistry assay.2 GLOW study data were presented at the March American Society of Clinical Oncology (ASCO) Plenary Series.


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