VENTANA® MET (SP44) RxDx Assay
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First FDA-approved IHC companion diagnostic for determining MET protein expression in patients with NSQ-NSCLC eligible for treatment with Emrelis™ (telisotuzumab vedotin-tllv)1
The VENTANA MET (SP44) RxDx Assay is the first FDA-approved immunohistochemistry (IHC) assay to identify patients with non-squamous, non-small cell lung cancer (NSQ-NSCLC) who are eligible for MET-targeted treatment with Emrelis™ (telisotizumab vedotin).1
Lung cancer is one of the most frequently diagnosed cancers and is the leading cause of cancer-related death worldwide in both men and women.2 NSCLC represents approximately 80-85% of all new lung cancer cases. Patients diagnosed with advanced NSCLC often face a poor prognosis, with median survival of less than one year.1,2
MET as a predictive biomarker in lung cancer
MET (also called tyrosine-protein kinase MET or c-MET) is a heterodimeric receptor tyrosine kinase encoded by the MET proto-oncogene located on chromosome 7q21-q31 and is expressed on the surface of various epithelial cells.3
This makes the MET protein an actionable target for antibody drug conjugates (ADCs).4,5
MET serves as a predictive biomarker for the likelihood of response to MET-targeted therapy for patients with NSCLC.1
MET protein overexpression is found in approximately 25% of advanced EGFR wild-type NSQ-NSCLC patients and is often associated with poor prognosis.5
MET clinical utility
The VENTANA MET (SP44) RxDx Assay is indicated as an aid in identifying NSQ-NSCLC patients who may be eligible for treatment with Emrelis™ (telisotuzumab vedotin).1
Approval is based on data from AbbVie's Phase 2 LUMINOSITY trial. The test was used as the enrollment assay to identify patients whose tumors were positive for MET, defined as >50% tumor cells (TC) demonstrating strong (3+) membrane staining. For more information, visit EMRELISHCP.com.2,6
Findings from LUMINOSITY showed patients with high MET protein expression who received Emrelis™ demonstrated
overall response rate (ORR) and duration of response (DoR) with a median of 7.2 months.6
VENTANA MET (SP44) RxDx Assay staining and scoring
VENTANA MET (SP44) RxDx Assay staining in NSQ-NSCLC exhibits a membranous and/or cytoplasmic pattern. The staining signal intensity is classified as strong, moderate, weak, or negative based on membranous and/or cytoplasmic localization.1
In NSQ-NSCLC, tumor cells stained with VENTANA MET (SP44) RxDx Assay are evaluated for percentage of tumor cells exhibiting strong (3+) intensity. Strong staining intensity is characterized by dark brown to black staining of the membranes and/or cytoplasm. Strong staining membranes and/or cytoplasm are easily detectable at low power magnifications such as 2x or 4x.1
NSQ-NSCLC tissue cases are considered positive for MET status if ≥ 50% of viable tumor cells demonstrate strong membranous and/or cytoplasmic staining.1
Detecting MET is key to determining eligibility for Emrelis™.
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References
- Roche. VENTANA MET (SP44) RxDx Assay, US Package Insert. 2025.
- 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.
- American Society of Clinical Oncology. What is Lung Cancer? https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed Jan 21, 2025.
- Trusolino, L, Bertotti, A, & Comoglio, PM (2010). MET signalling: Principles and functions in development, organ regeneration and cancer. Nature Reviews Molecular Cell Biology, 11(12), 834-848. doi:10.1038/nrm3012.
- Wang J, Anderson MG, Oleksijew A, et al. ABBV-399, a c-Met Antibody–Drug Conjugate that Targets Both MET–Amplified and c-Met–Overexpressing Tumors, Irrespective of MET Pathway Dependence. Clin Cancer Res 15 February 2017; 23 (4): 992–1000. https://doi.org/10.1158/1078-0432.CCR-16-1568.
- AbbVie press release. U.S. FDA Approves Emrelis™ (telisotuzumab vedotin-tllv) for Adults with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) with c-Met Protein Overexpression. 2025.
