by Lori Solomon

The U.S. Food and Drug Administration has approved Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2-positive as determined by an FDA-approved test.

Vyloy has become the first and only CLDN18.2-targeted therapy approved in the United States.

The approval is based on the phase 3 SPOTLIGHT and GLOW clinical trials, in which approximately 38% of screened patients had tumors that were CLDN18.2-positive (defined as ≥75% of tumor cells demonstrating moderate-to-strong membranous CLDN18 immunohistochemical staining), as determined by the Ventana CLDN18 (43-14A) RxDx Assay (Roche).

Both the SPOTLIGHT study (Vyloy plus the combination of mFOLFOX6 chemotherapy regimen of oxaliplatin, leucovorin, and fluorouracil versus placebo plus mFOLFOX6) and the GLOW study (Vyloy plus the combination of CAPOX chemotherapy regimen of capecitabine and oxaliplatin versus placebo plus CAPOX) met their primary end point of progression-free survival. Both studies also met the key secondary end point of overall survival for patients treated with Vyloy plus chemotherapy. The most common all-grade treatment-emergent adverse events reported in the Vyloy treatment arms of the trials were nausea, vomiting, and decreased appetite.

"While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in the last several years, there is still a tremendous unmet need among our patients," Samuel J. Klempner, M.D., from Massachusetts General Hospital in Boston, said in a statement.

Approval of Vyloy was granted to Astellas Pharma.

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