Zolbetuximab: First Approval

Lordick F, Carneiro F, Cascinu S, et al. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022;33(10):1005–20.

Article  CAS  PubMed  Google Scholar 

National Cancer Institute. Stomach cancer treatment. 2023. https://www.cancer.gov/. Accessed 8 Apr 2024

Shah MA, Shitara K, Ajani JA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023;29(8):2133–41.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023;401(10389):1655–68.

Article  CAS  PubMed  Google Scholar 

Kubota Y, Shitara K. Zolbetuximab for claudin 18.2-positive gastric or gastroesophageal junction cancer. Ther Adv Med Oncol. 2024;16:1–18.

Article  Google Scholar 

Désilets A, Elkhoury R, Gebai A, et al. Current and emerging role of monoclonal antibody-based first-line treatment in advanced gastro-esophageal and gastric cancer. Curr Oncol. 2023;30(10):9304–16.

Article  PubMed  PubMed Central  Google Scholar 

Wang X, Zhang CS, Dong XY, et al. Claudin 18.2 is a potential therapeutic target for zolbetuximab in pancreatic ductal adenocarcinoma. World J Gastrointest Oncol. 2022;14(7):1252–64.

Article  PubMed  PubMed Central  Google Scholar 

Park S, Shin K, Kim IH, et al. Clinicopathological features and prognosis of resected pancreatic ductal adenocarcinoma patients with claudin 18 overexpression. J Clin Med. 2023;12(16):5394.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Sahin U, Koslowski M, Dhaene K, et al. Claudin 18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody development. Clin Cancer Res. 2008;14(23):7624–34.

Article  CAS  PubMed  Google Scholar 

Shitara K, Xu R-H, Moran DM, et al. Global prevalence of CLDN18.2 in patients with locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Biomarker analysis of two zolbetuximab phase 3 studies (SPOTLIGHT and GLOW) [abstract no. 4035]. J Clin Oncol. 2023;41:4035.

Article  Google Scholar 

Moran DM, Guerrero A, Ueno Y, et al. Prevalence of claudin 18.2 (CLDN18.2) and the association of biomarkers with clinical activity in patients with gastric or gastroesophageal adenocarcinoma (G/GEJa) treated with zolbetuximab [abstract no. 466]. J Clin Oncol. 2023;41(4 Suppl):466.

Article  Google Scholar 

Wöll S, Schlitter AM, Dhaene K, et al. Claudin 18.2 is a target for IMAB362 antibody in pancreatic neoplasms. Int J Cancer. 2014;134(3):731–9.

Article  PubMed  Google Scholar 

Türeci Ӧ, Mitnacht-Kraus R, Wöll S, et al. Characterization of zolbetuximab in pancreatic cancer models. Oncoimmunology. 2019;8(1): e1523096.

Article  PubMed  Google Scholar 

Sahin U, Schuler M, Richly H, et al. A phase I dose-escalation study of IMAB362 (zolbetuximab) in patients with advanced gastric and gastro-oesophageal junction cancer. Eur J Cancer. 2018;100:17–26.

Article  CAS  PubMed  Google Scholar 

Astellas Pharma Inc. Zolbetuximab: Japanese prescibing information. 2024. https://www.pmda.go.jp/. Accessed Apr 8 2024.

Lordick F, Thuss-Patience P, Bitzer M, et al. Immunological effects and activity of multiple doses of zolbetuximab in combination with zoledronic acid and interleukin-2 in a phase 1 study in patients with advanced gastric and gastroesophageal junction cancer. J Cancer Res Clin Oncol. 2023;149(9):5937–50.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Astellas Pharma Inc. Astellas’ VYLOY™ (zolbetuximab) approved in Japan for treatment of gastric cancer [media release]. 26 Mar 2024. https://www.astellas.com/.

Astellas Pharma Inc. VYLOY™ (zolbetuximab) Japan regulatory update. 2024. https://www.astellas.com/. Accessed 8 Apr 8 2024

Roche Diagnostics. VENTANA® CLDN18 (43-14A) assay. 2024. https://diagnostics.roche.com/. Accessed 24 Apr 2024.

Yang J, Yamada A, Klempner SJ, et al. Clinical pharmacology profile of the claudin 18.2 antibody zolbetuximab [abstract no. 316]. J Clin Oncol. 2024;42(3 Suppl):316.

Article  Google Scholar 

Astellas Pharma Inc. Astellas provides update on zolbetuximab biologics license application in US [media release]. 8 Jan 2024. https://www.astellas.com.

Astellas Pharma Inc. European Medicines Agency accepts Astellas' marketing authorization application for zolbetuximab [media release]. 13 Jul 2023. https://www.astellas.com.

Astellas Pharma Inc. China's National Medical Products Administration accepts Astellas' biologics license application for zolbetuximab [media release]. 31 Jul 2023. https://www.astellas.com.

Australian Government Department of Health and Aged Care: Therapeutic Goods Administration. Prescription medicines under evaluation: VYLOY. 2023. https://www.tga.gov.au/. Accessed 29 Apr 2024.

Astellas Pharma Inc. Astellas completes acquisition of Ganymed Pharmaceuticals [media release]. 21 Dec 2016. https://www.astellas.com.

Mitnacht-Kraus R, Kreuzberg M, Utsch M, et al. Preclinical characterization of IMAB362 for the treatment of gastric carcinoma [abstract no. 378P]. Ann Oncol. 2017;28(Suppl 5):126.

Article  Google Scholar 

Nakayama T, Oishi M, Weng J, et al. Antitumor activity of zolbetuximab combined with chemotherapy and anti-mouse PD-1 antibody (anti-mPD-1) in a syngeneic mouse model and a virtual preclinical trial using a quantitative systems pharmacology (QSP) model [abstract no. 42P). Ann Oncol. 2022;33(Suppl 7):S559–60.

Article  Google Scholar 

Ajani JA, Lordick F, Bang YJ, et al. Updated efficacy and safety results from phase III SPOTLIGHT study evaluating zolbetuximab+mFOLFOX6 as first-line (1L) treatment for patients with claudin-18 isoform 2-positive (CLDN18.2+), HER2L, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma [abstract no. 135MO]. Ann Oncol. 2023;34(Suppl 4):S1524–5.

Article  Google Scholar 

Lordick F, Shah MA, Shitara K, et al. Updated efficacy and safety results from phase III GLOW study evaluating zolbetuximab plus CAPOX as first-line (1L) treatment for patients with claudin-18 isoform 2-positive (CLDN18.2+), HER2-, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma [abstract no. 134MO]. Ann Oncol. 2023;34(Suppl 4):S1524.

Article  Google Scholar 

Sahin U, Türeci Ö, Manikhas G, et al. FAST: a randomised phase II study of zolbetuximab (IMAB362) plus EOX versus EOX alone for first-line treatment of advanced CLDN18.2-positive gastric and gastro-oesophageal adenocarcinoma. Ann Oncol. 2021;32(5):609–19.

Article  CAS  PubMed  Google Scholar 

Klempner SJ, Lee KW, Shitara K, et al. ILUSTRO: phase II multicohort trial of zolbetuximab in patients with advanced or metastatic claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma. Clin Cancer Res. 2023;29(19):3882–91.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Pharmaceuticals and Medical Devices Agency. Information on companion diagnostics, etc. 2024. https://www.pmda.go.jp/. Accessed 30 Apr 2024.

Comments (0)

No login
gif