Vyloy^® (zolbetuximab-clzb)

FOR IMMEDIATE RELEASE:

Onco360 Has Been Selected as a National Specialty Pharmacy Partner for Vyloy^® (zolbetuximab-clzb)  

Louisville, KY — November 26, 2024 — Onco360^®, the nation’s leading independent specialty pharmacy, has been selected as a national pharmacy partner by Astellas for Vyloy^® (zolbetuximab-clzb), approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive, as determined by an FDA-approved test.¹ This indication was approved based on the Phase III GLOW trial, (NCT03653507) which compared zolbetuximab plus capecitabine and oxaliplatin (CAPOX) to placebo with (CAPOX),² and the SPOTLIGHT (NCT03504397) clinical trial, which compared zolbetuximab plus mFOLFOX6 to placebo with mFOLFOX6.³

Vyloy^® is currently the first and only approved monoclonal antibody specifically designed to target gastric tumor cells that express the biomarker claudin (CLDN) 18.2. Claudin 18.2 as a component of tight junctions, has a role in the regulation of permeability, barrier function, and polarity of epithelial layers. About 38% of advanced gastric and gastroesophageal junction cancers are CLDN18.2 positive, defined as >75% of tumor cells with moderate-to-strong membranous CLDN18 immunohistochemical (IHC) staining.⁴ Gastric cancer is the 15th most common cancer and the 17th leading cause of cancer-related death in the United States.⁵

“Onco360 is grateful for the opportunity to partner with the team at Astellas and become a specialty pharmacy provider for Vyloy^®,” said Benito Fernandez, Chief Commercial Officer. “We are proud to add another treatment option for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) cancers.”

The FDA approval of Vyloy^® is based on the results of the Phase III GLOW and SPOTLIGHT clinical trials. In the SPOTLIGHT trial, a median progression free survival (PFS) of 10.61 months was achieved with zolbetuximab plus mFOLFOX6 as first-line treatment, versus 8.67 months with placebo plus mFOLFOX6. The median overall survival (OS) was 18.23 months versus 15.54 months in the respective treatment groups.⁶ Similar findings were seen in the GLOW trial where median PFS was 8.21 months versus 6.80 months and median OS 14.39 months versus 12.16 months, with zolbetuximab plus CAPOX and placebo plus CAPOX, respectively.²  

The most common (≥ 25%) adverse reactions and lab abnormalities in the SPOTLIGHT trial were nausea (82%), albumin decreased (78%), vomiting (67%), decreased appetite (47%), and decreased glucose (45%). The most common (≥ 25%) adverse reactions in the GLOW trial were decreased neutrophil count (76%), nausea (69%), vomiting (66%), albumin decreased (66%), leukocytes decreased (66%), and decreased appetite (41%).

Please see the full Prescribing Information for Vyloy^®.

Media Contact: Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332

References:

¹Vyloy (Zolbetuximab) [Prescribing Information]. Northbrook, IL. Astellas. Accessed October 2024. https://www.astellas.com/us/system/files/vyloy_pi.pdf

²Shah, M.A., Shitara, K., Ajani, J.A. et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med (2023). https://doi.org/10.1038/s41591-023-02465-7.

³Kohei Shitara et al. Final overall survival results from phase 3 SPOTLIGHT study evaluating zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) with claudin 18 isoform 2 (CLDN18.2)+, HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma.. JCO 42, 4036-4036(2024). DOI:10.1200/JCO.2024.42.16_suppl.4036

⁴Otto, M A. FDA OKs Zolbetuximab for Gastric, Gastroesophageal Cancer. Accessed October 20, 2024.  FDA OKs Zolbetuximab for Gastric, Gastroesophageal Cancer

⁵National Cancer Institute. Cancer stat facts: stomach cancer.  https://seer.cancer.gov/statfacts/html/stomach.html

⁶Van Laarhoven, et al. Claudin-18.2 targeting by zolbetuximab: results of SPOTLIGHT in perspective. The Lancet Vol 401, Iss 10389, p1630-1631, May 20, 2023.