Phase III SPOTLIGHT trial of IMAB 362 in gastric or gastroesophageal junction (GEJ) adenocarcinoma published in The Lancet.- Astellas Pharma
Astellas Pharma announced that The Lancet published detailed data from the Phase III SPOTLIGHT trial evaluating first-line treatment with IMAB 362 (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. 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.
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 III trials will serve as the basis for global regulatory submissions. In both trials, approximately 38% of these patients had CLDN18.2-positive tumors (at least 75% of tumor cells with strong-to-moderate membranous CLDN18 staining intensity), as determined by a validated immunohistochemistry assay. GLOW study data were presented at the March American Society of Clinical Oncology (ASCO) Plenary Series.
See: "Zolbetuximab plus mFOLFOX6 in patients with claudin-18 isoform 2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastrooesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase III trial." Shitara K, et al. The Lancet. Published online April 14, 2023; S0140-6736(23)00620-7.
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