Roche obtains CE certification for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY
Roche has obtained CE certification for the VENTANA CLDN18 (43-14A) RxDx Assay, the first companion diagnostic to identify patients with gastric and gastroesophageal junction (GEJ) cancer eligible for targeted treatment with VYLOY. This immunohistochemistry (IHC) test determines CLDN18 protein expression in tumors, helping clinicians identify patients who may benefit from Astellas' targeted therapy VYLOY (zolbetuximab).
The assay addresses an unmet medical need by enabling personalized treatment options for gastric and GEJ cancer patients. CLDN18.2 is an emerging biomarker that helps predict the likelihood of response to targeted therapy. With gastric cancer being the fifth most common cancer worldwide and having low survival rates, especially in Europe, this diagnostic tool represents a significant advancement in patient care and treatment decision-making.
Roche ha ottenuto la certificazione CE per il VENTANA CLDN18 (43-14A) RxDx Assay, il primo diagnostico companion per identificare i pazienti con cancro gastrico e del giunzione gastroesofagea (GEJ) idonei per un trattamento mirato con VYLOY. Questo test di immunoistochimica (IHC) determina l'espressione della proteina CLDN18 nei tumori, aiutando i medici a identificare i pazienti che potrebbero beneficiare della terapia mirata di Astellas, VYLOY (zolbetuximab).
Il test risponde a una necessità medica insoddisfatta, consentendo opzioni di trattamento personalizzate per i pazienti con cancro gastrico e GEJ. CLDN18.2 è un biomarcatore emergente che aiuta a prevedere la probabilità di risposta alla terapia mirata. Con il cancro gastrico che è il quinto cancro più comune al mondo e ha basse percentuali di sopravvivenza, specialmente in Europa, questo strumento diagnostico rappresenta un significativo progresso nella cura dei pazienti e nella presa di decisioni sul trattamento.
Roche ha obtenido la certificación CE para el VENTANA CLDN18 (43-14A) RxDx Assay, el primer diagnóstico companion para identificar a los pacientes con cáncer gástrico y de la unión gastroesofágica (GEJ) que son elegibles para tratamiento dirigido con VYLOY. Esta prueba de inmunohistoquímica (IHC) determina la expresión de la proteína CLDN18 en los tumores, ayudando a los clínicos a identificar a los pacientes que podrían beneficiarse de la terapia dirigida de Astellas, VYLOY (zolbetuximab).
El análisis aborda una necesidad médica no satisfecha al permitir opciones de tratamiento personalizadas para pacientes con cáncer gástrico y GEJ. CLDN18.2 es un biomarcador emergente que ayuda a predecir la probabilidad de respuesta a la terapia dirigida. Con el cáncer gástrico siendo el quinto cáncer más común en el mundo y teniendo tasas de supervivencia bajas, especialmente en Europa, esta herramienta de diagnóstico representa un avance significativo en el cuidado del paciente y en la toma de decisiones sobre el tratamiento.
로슈는 CE 인증을 받아 VENTANA CLDN18 (43-14A) RxDx 검사를 출시했습니다. 이는 위암 및 위식도 접합부(GEJ) 암 환자를 식별하기 위한 첫 번째 동반 진단 도구로, VYLOY로 표적 치료를 받을 수 있는 환자를 확인할 수 있습니다. 이 면역조직화학(IHC) 테스트는 종양에서 CLDN18 단백질 발현을 측정하여, Astellas의 표적 치료제인 VYLOY(졸베툭시맙)로 혜택을 받을 수 있는 환자를 찾아냅니다.
이 검사는 위암 및 GEJ 암 환자를 위한 개인화된 치료 옵션을 가능하게 하여 미충족 의료 수요를 해결합니다. CLDN18.2는 표적 치료에 대한 반응 가능성을 예측하는 데 도움이 되는 새로운 바이오마커입니다. 위암은 전 세계에서 다섯 번째로 흔한 암이며 유럽에서는 낮은 생존율을 보이고 있어서, 이 진단 도구는 환자 관리 및 치료 결정에서 중요한 발전을 의미합니다.
Roche a obtenu la certification CE pour le VENTANA CLDN18 (43-14A) RxDx Assay, le premier test diagnostique compagnon pour identifier les patients atteints de cancer gastrique et de la jonction gastroœsophagienne (GEJ) éligibles à un traitement ciblé avec VYLOY. Ce test d'immunohistochimie (IHC) détermine l'expression de la protéine CLDN18 dans les tumeurs, aidant les cliniciens à identifier les patients qui pourraient bénéficier de la thérapie ciblée d'Astellas, VYLOY (zolbetuximab).
Ce test répond à un besoin médical non satisfait en permettant des options de traitement personnalisées pour les patients atteints de cancer gastrique et de GEJ. CLDN18.2 est un biomarqueur émergent qui aide à prédire la probabilité de réponse à la thérapie ciblée. Avec le cancer gastrique étant le cinquième cancer le plus courant dans le monde et présentant de faibles taux de survie, notamment en Europe, cet outil diagnostique représente une avancée significative dans les soins aux patients et la prise de décision en matière de traitement.
Roche hat die CE-Zertifizierung für den VENTANA CLDN18 (43-14A) RxDx-Assay erhalten, den ersten begleitenden Diagnosetest zur Identifizierung von Patienten mit Magenkrebs und Krebs des gastroösophagealen Übergangs (GEJ), die für eine zielgerichtete Behandlung mit VYLOY geeignet sind. Dieser immunhistochemische (IHC) Test bestimmt die CLDN18-Proteinexpression in Tumoren und hilft den Kliniken, Patienten zu identifizieren, die von der zielgerichteten Therapie von Astellas, VYLOY (Zolbetuximab), profitieren könnten.
Der Test adressiert ein unbefriedigtes medizinisches Bedürfnis, indem er personalisierte Behandlungsoptionen für Magen- und GEJ-Krebspatienten ermöglicht. CLDN18.2 ist ein aufkommender Biomarker, der dabei hilft, die Wahrscheinlichkeit einer Reaktion auf die zielgerichtete Therapie vorherzusagen. Da Magenkrebs weltweit die fünfhäufigste Krebsart ist und vor allem in Europa niedrige Überlebensraten aufweist, stellt dieses Diagnosetool einen bedeutenden Fortschritt in der Patientenversorgung und Entscheidungsfindung bei der Behandlung dar.
- First CE-certified companion diagnostic for gastric and GEJ cancer targeting CLDN18.2
- Enables identification of patients eligible for targeted treatment with VYLOY
- Addresses unmet medical need in personalized gastric cancer treatment
- Expands treatment possibilities for gastric and GEJ cancer patients
- None.
- The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option.
- CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy.
- As the leader in companion diagnostics, Roche continues to build on its commitment to improve personalised healthcare to enable better patient outcomes.
Basel, 10 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANAⓇ CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas’ targeted therapy VYLOYTM (zolbetuximab).
“Gastric cancer remains a significant global health challenge. In Europe, only three percent of patients with metastatic disease live beyond five years," said Matt Sause, CEO of Roche Diagnostics. "Our new companion diagnostic is a significant step forward for patients. By identifying those who may benefit from a targeted treatment, this new test can expand treatment possibilities, and aid clinicians to potentially improve outcomes.”
Current guidelines for gastric/GEJ cancer recommend using biomarkers to guide therapeutic decision making. The new VENTANA CLDN18 (43-14A) RxDx Assay can help determine CLDN18.2 status and inform clinicians about the likelihood of patients benefiting from CLDN18.2 targeted therapy.4 VYLOY is the first approved treatment specifically targeting CLDN18.2-positive gastric/GEJ cancer, expanding options for patients to receive therapies appropriate for their specific disease.5
Gastric cancer is the fifth most common cancer worldwide,1 with some of the highest rates observed in Central and Eastern Europe.1 The disease is often diagnosed late, because signs and symptoms are common to other conditions,6 resulting in an overall survival rate of just
About the VENTANA CLDN18 (43-14A) RxDx Assay
The VENTANA CLDN18 (43-14A) RxDx Assay is a qualitative immunohistochemical assay intended to be used in the assessment of Claudin 18 (CLDN18) protein in gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma. The OptiView DAB IHC Detection Kit is used for staining on a BenchMark ULTRA instrument. The assay is indicated as an aid in identifying patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with VYLOY® (zolbetuximab) in accordance with the approved therapeutic product labelling. The Roche test measures expression of both variants of the CLDN18 protein (18.1 and 18.2 isoforms). CLDN18.2 is the predominant variant expressed in gastric and GEJ cancers.4,8
The approval of the VENTANA CLDN18 (43-14A) RxDx Assay is based on the results of the SPOTLIGHT and GLOW clinical studies where it was used as the enrollment assay to identify patients whose tumours were CLDN18.2 positive. CLDN18.2 positivity is defined as ≥
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
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References
[1] Ferlay J, Ervik M, et al. Global Cancer Observatory: Cancer Today (2024). Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today. Accessed September 19, 2024.
[2] Brenner H, Rothenbacher D, et al. Epidemiology of stomach cancer. Methods Mol Biol. 2009;472:467–77.
[3] Yang D, Hendifar A, et al. Survival of metastatic gastric cancer: Significance of age, sex and race/ethnicity. J Gastrointest Oncol. 2011 Jun;2(2):77-84.
[4] Roche. VENTANA CLDN18 (43-14A) RxDx Assay, CE Package Insert, 2024.
[5] Astellas press release, Astellas’ VYLOY™ (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer, https://www.astellas.com/en/news/29026. Accessed September 19, 2024.
[6] National Cancer Institute. Gastric Cancer Treatment (PDQ®)-Patient Version. https://www.cancer.gov/types/stomach/patient/stomach-treatment-pdq. Accessed September 19, 2024.
[7] European Network of Cancer Registries, Stomach Cancer Factsheet, 2017.
[8] Saito, T. Matsuda, D. Moran, P-114 Claudin 18 isoform expression in gastric adenocarcinoma and pancreatic adenocarcinoma, Annals of Oncology, Volume 32, Supplement 3, 2021, Page S138, ISSN 0923-7534, https://doi.org/10.1016/j.annonc.2021.05.169.
[9] Astellas press release, Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium. https://www.astellas.com/en/news/26946. Accessed September 19, 2024.
[10] Astellas press release, Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series. https://www.astellas.com/en/news/27481. Accessed September 19, 2024.
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FAQ
What is the VENTANA CLDN18 (43-14A) RxDx Assay approved for by Roche (RHHBY)?
How does the VENTANA CLDN18 (43-14A) RxDx Assay benefit gastric cancer patients?
What is the significance of CLDN18.2 in gastric cancer treatment?
What are the current survival rates for gastric cancer in Europe according to Roche (RHHBY)?
