NEW YORK – The European Commission on Friday approved Astellas Pharma's Vyloy (zolbetuximab) plus chemo as a first-line treatment for patients with locally advanced, unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN)18.2 positive.
The EC approved the CLDN18.2-targeted therapy after reviewing data from the Phase III SPOTLIGHT and GLOW clinical trials. In SPOTLIGHT, patients on Vyloy plus mFOLFOX6 had a median progression-free survival of 10.61 months versus 8.67 months for those on placebo plus mFOLFOX6. Vyloy plus chemo also improved median overall survival against chemo alone: 18.23 months versus 15.54 months, respectively.
The GLOW trial showed similar efficacy for Vyloy when it was combined with another chemo regimen, CAPOX, and compared to just CAPOX. Patients in the Vyloy-CAPOX arm had a median progression-free survival of 8.21 months versus 6.80 months on the CAPOX-placebo arm, and a median overall survival of 14.39 months versus 12.16 months, respectively.
Vyloy is the first CLDN18.2-targeted treatment the EC has approved. Approximately 38 percent of advanced gastric cancer patients have CLDN18.2-expressing tumors, according to Astellas.
The UK's Medicines and Healthcare Products Regulatory Agency in August approved Vyloy with chemo in this same indication, as did Japanese regulators in March.
In May, Astellas resubmitted a biologics license application (BLA) seeking approval for Vyloy plus chemo in this setting after the US Food and Drug Administration sent a complete response letter in January following the firm's initial application. In the letter, the agency said it would not approve the initial BLA due to deficiencies at a third-party manufacturing facility that produces the drug. The FDA is expected to issue a regulatory decision on Vyloy based on information in the resubmitted BLA by Nov. 9.