Roche receives FDA approval for the VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-squamous non-small cell lung cancer patients eligible for treatment with Emrelis
Roche (RHHBY) has received FDA approval for its VENTANA MET (SP44) RxDx Assay, marking it as the first companion diagnostic test to identify non-squamous non-small cell lung cancer (NSQ-NSCLC) patients eligible for AbbVie's Emrelis treatment. The assay detects MET protein expression, a crucial biomarker for determining patient response to c-Met-targeted therapy.
The approval is backed by the Phase 2 LUMINOSITY study, which demonstrated a 35% overall response rate and 7.2 months median duration of response in patients with high c-Met protein expression treated with Emrelis. This development is particularly significant as approximately 25% of advanced NSCLC patients with normal EGFR genes show high MET protein levels.
Roche (RHHBY) ha ottenuto l'approvazione FDA per il suo test diagnostico VENTANA MET (SP44) RxDx, diventando il primo test diagnostico complementare per identificare i pazienti con carcinoma polmonare non a piccole cellule non squamoso (NSQ-NSCLC) idonei al trattamento Emrelis di AbbVie. Il test rileva l'espressione della proteina MET, un biomarcatore fondamentale per valutare la risposta del paziente alla terapia mirata contro c-Met.
L'approvazione si basa sullo studio di Fase 2 LUMINOSITY, che ha evidenziato un tasso di risposta complessivo del 35% e una durata mediana della risposta di 7,2 mesi nei pazienti con alta espressione della proteina c-Met trattati con Emrelis. Questo risultato è particolarmente rilevante poiché circa il 25% dei pazienti con NSCLC avanzato e geni EGFR normali presenta livelli elevati di proteina MET.
Roche (RHHBY) ha recibido la aprobación de la FDA para su ensayo VENTANA MET (SP44) RxDx, convirtiéndolo en la primera prueba diagnóstica complementaria para identificar a pacientes con cáncer de pulmón no microcítico no escamoso (NSQ-NSCLC) elegibles para el tratamiento Emrelis de AbbVie. El ensayo detecta la expresión de la proteína MET, un biomarcador crucial para determinar la respuesta del paciente a la terapia dirigida contra c-Met.
La aprobación está respaldada por el estudio de Fase 2 LUMINOSITY, que mostró una tasa de respuesta global del 35% y una duración media de la respuesta de 7,2 meses en pacientes con alta expresión de la proteína c-Met tratados con Emrelis. Este avance es especialmente significativo dado que aproximadamente el 25% de los pacientes con NSCLC avanzado y genes EGFR normales presentan niveles altos de proteína MET.
로슈(RHHBY)는 FDA 승인을 받아 VENTANA MET (SP44) RxDx 검사를 출시했습니다. 이 검사는 AbbVie의 Emrelis 치료에 적합한 비편평 비소세포폐암(NSQ-NSCLC) 환자를 식별하는 최초의 동반진단 검사입니다. 이 검사는 c-Met 표적 치료에 대한 환자의 반응을 결정하는 중요한 바이오마커인 MET 단백질 발현을 감지합니다.
승인은 2상 LUMINOSITY 연구에 근거하며, 이 연구에서는 Emrelis로 치료받은 고농도 c-Met 단백질 발현 환자에서 전체 반응률 35%와 중간 반응 지속 기간 7.2개월을 보였습니다. 이 개발은 약 25%의 진행성 NSCLC 환자가 정상 EGFR 유전자를 가졌음에도 불구하고 높은 MET 단백질 수치를 보인다는 점에서 특히 중요합니다.
Roche (RHHBY) a obtenu l'approbation de la FDA pour son test VENTANA MET (SP44) RxDx, devenant ainsi le premier test diagnostique compagnon permettant d’identifier les patients atteints de cancer du poumon non à petites cellules non squameux (NSQ-NSCLC) éligibles au traitement Emrelis d’AbbVie. Ce test détecte l'expression de la protéine MET, un biomarqueur clé pour déterminer la réponse des patients à la thérapie ciblant c-Met.
Cette approbation repose sur l'étude de phase 2 LUMINOSITY, qui a démontré un taux de réponse global de 35% et une durée médiane de réponse de 7,2 mois chez les patients présentant une forte expression de la protéine c-Met traités avec Emrelis. Cette avancée est particulièrement importante car environ 25 % des patients atteints de NSCLC avancé avec des gènes EGFR normaux présentent des niveaux élevés de protéine MET.
Roche (RHHBY) hat die FDA-Zulassung für seinen VENTANA MET (SP44) RxDx-Test erhalten, der als erster Begleitdiagnostiktest Patienten mit nicht-plattenepithelialem nicht-kleinzelligem Lungenkrebs (NSQ-NSCLC) identifiziert, die für die Behandlung mit AbbVies Emrelis infrage kommen. Der Test erkennt die MET-Proteinexpression, einen wichtigen Biomarker zur Bestimmung der Patientenreaktion auf die c-Met-gerichtete Therapie.
Die Zulassung stützt sich auf die Phase-2-Studie LUMINOSITY, die eine Gesamtansprechrate von 35% und eine mittlere Ansprechdauer von 7,2 Monaten bei Patienten mit hoher c-Met-Proteinexpression unter Emrelis-Behandlung zeigte. Diese Entwicklung ist besonders bedeutsam, da etwa 25 % der fortgeschrittenen NSCLC-Patienten mit normalen EGFR-Genen hohe MET-Proteinwerte aufweisen.
- First FDA-approved companion diagnostic for detecting MET protein expression in NSQ-NSCLC
- Positive Phase 2 LUMINOSITY study results showing 35% overall response rate
- Addresses significant market need with 25% of advanced NSCLC patients showing high MET protein levels
- Expands Roche's market-leading portfolio of companion diagnostics
- Limited duration of response at 7.2 months median
- FDA approval is accelerated, requiring additional confirmatory data
- The VENTANA MET (SP44) RxDx Assay detects the MET (also known as c-Met) protein, which is over-expressed in some patients with non-squamous non-small cell lung cancer (NSQ-NSCLC).
- The MET protein serves as a predictive biomarker for the likelihood of a patient’s response to c-Met-targeted therapy.1
- As the leader in companion diagnostics, Roche’s broad CDx portfolio helps enable informed clinical decisions and improved patient outcomes.
Basel, 14 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the FDA has approved the VENTANA® MET (SP44) RxDx Assay, the first companion diagnostic approved to aid in determining MET (also known as c-Met) protein expression in NSQ-NSCLC patients. These patients may now be eligible for treatment with AbbVie’s c-Met-targeted therapy Emrelis™ (telisotuzumab vedotin-tllv).2,3
“Understanding the molecular drivers in patients with non-small cell lung cancer is critical for therapy selection,” said Matt Sause, CEO of Roche Diagnostics. “By identifying MET protein expression at the appropriate stage in the patient journey, we can help provide timely, tailored treatment options that may improve patient outcomes and offer hope to those facing this challenging disease.”
Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths in both men and women throughout the world.4 Lung cancer is often diagnosed at an advanced stage when treatment options are limited;5 median survival is less than one year.2 Approximately
Among advanced NSCLC patients with a normal (wild-type) epidermal growth factor receptor (EGFR) gene, around a quarter exhibit high levels of MET protein,7 making MET protein expression an important factor in determining treatment options for patients with this type of cancer.
The FDA accelerated approval is supported by data from the Phase 2 LUMINOSITY study, an ongoing study designed to characterize the efficacy and safety of Emrelis in c-Met overexpressing advanced NSQ-NSCLC populations. Findings from the study showed patients with c-Met protein high expression who received Emrelis demonstrated
The launch of the first immunohistochemistry (IHC) MET companion test exemplifies Roche’s commitment in this area, and represents an important addition to the company’s market-leading portfolio of immunohistochemistry (IHC) and in situ hybridisation (ISH) companion diagnostics. These diagnostics are designed to provide critical insights that enable more informed clinical decisions, advancing personalised healthcare and improving patients’ lives.
About the VENTANA MET (SP44) RxDx Assay
The VENTANA MET (SP44) RxDx Assay detects the MET protein and is scored by pathologists based on the percentage of tumour cells stained and the intensity of the staining.2,3 The FDA’s approval is based on data from AbbVie’s Phase 2 LUMINOSITY clinical study, in which the test was used as the enrollment assay. MET protein overexpression is defined as ≥
By providing critical information on MET protein expression, the assay informs clinicians about the likelihood that a patient will benefit from c-Met-targeted therapy, allowing for a more personalised approach to treating NSQ-NSCLC.
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.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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References
[1] Lee, M., et al. MET alterations and their impact on the future of non-small cell lung cancer (NSCLC) targeted therapies. Expert Opinion on Therapeutic Targets, 25(4), 249–268 (2021).
[2] Roche. VENTANA MET (SP44) RxDx Assay, US Package Insert. 2025.
[3] Roche. VENTANA MET (SP44) RxDx Assay, US Interpretation guide. 2025.
[4] Siegel RL, Miller KD, Jemal A. "Cancer Statistics, 2020." CA: A Cancer Journal for Clinicians. 2020;70(1):7-30. doi:10.3322/caac.21590.
[5] World Health Organization, Lung Cancer Factsheet, available at: https://www.who.int/news-room/fact-sheets/detail/lung-cancer#:~:text=Lung%20cancer%20is%20often%20diagnosed,to%20dramatically%20improve%20survival%20rates. Last accessed 21 January 2025
[6] National Cancer Institute. (2021). Non-Small Cell Lung Cancer Treatment (PDQ®)–Patient Version. Retrieved from https://www.cancer.gov/types/lung/patient/non-small-cell-lung-treatment-pdq
[7] Bean J, Brennan C, Shih JY, et al. MET amplification occurs with or without T790M mutations in EGFR mutant lung tumors with acquired resistance to gefitinib or erlotinib. Proc Natl Acad Sci U S A. 2007;104(52):20932-20937. doi:10.1073/pnas.0710370104.
[8] Camidge DR, et al. Telisotuzumab Vedotin monotherapy in patients with previously treated c-Met protein-overexpressing advanced nonsquamous EGFR-wildtype non-small cell lung cancer in the Phase II LUMINOSITY trial. J Clin Oncol. 2024 Sep 1;42(25):3000-3011. doi: 10.1200/JCO.24.00720. Epub 2024 Jun 6. PMID: 38843488; PMCID: PMC11361350.
[9] AbbVie Announces Positive Topline Results from Phase 2 LUMINOSITY Trial Evaluating Telisotuzumab-Vedotin (Teliso-V) for Patients with Previously Treated Non-Small Cell Lung Cancer (NSCLC) November 2023
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