Astellas Pharma has secured the US Food and Drug Administration (FDA) approval for Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy to treat a type of gastric or gastroesophageal junction (GEJ) cancer.
Vyloy is a cytolytic monoclonal antibody (mAb) therapy that targets and binds to claudin 18.2 (CLDN 18.2), a transmembrane protein, and depletes CLDN18.2-positive cells.
Together with chemotherapy, the drug is indicated for adults with locally advanced HER2-negative gastric or GEJ adenocarcinoma whose tumours are CLDN 18.2-positive.
Astellas has teamed up with Roche to provide the newly approved immunohistochemistry (IHC) companion diagnostic (CDx) test to identify patients who are eligible for Vyloy.
The company said that Vyloy is the first and only CLDN18.2-targeted therapy approved in the US.
Astellas senior vice president and immuno-oncology development head Moitreyee Chatterjee-Kishore said: “The approval of Vyloy as the first and only targeted therapy for CLDN18.2-positive patients in the US further delivers on our relentless pursuit of scientific progress for devastating diseases like gastric and GEJ cancers.
“This achievement is the result of years of dedicated research and development focused on targeting a novel biomarker, and we are grateful to the patients, investigators, and Astellas team members who have made this important advancement for patients a reality.”
The FDA approval is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials.
The SPOTLIGHT study evaluated Vyloy plus mFOLFOX6, a chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil, compared to placebo plus mFOLFOX6.
The GLOW study evaluated Vyloy plus CAPOX, a chemotherapy regimen that includes capecitabine and oxaliplatin, compared to placebo plus CAPOX.
Both the Phase 3 studies met their primary endpoint of progression-free survival (PFS), along with a key secondary endpoint, overall survival (OS).
In the studies, around 38% of the screened patients had CLDN18.2-positive tumours, as determined by Roche’s VENTANA CLDN18 (43-14A) RxDx Assay.
Roche’s VENTANA assay is an FDA-approved IHC test used to determine CLDN18.2 status.
With the FDA approval, Astellas’ Vyloy is currently approved in five global markets, including Japan, the UK, the European Union (EU), South Korea and the US.
