Roche has announced that the U.S. Food and Drug Administration (FDA) has approved the VENTANA® MET (SP44) RxDx Assay as the first companion diagnostic to detect MET protein expression in patients with non-squamous non-small cell lung cancer (NSQ-NSCLC). The approval allows clinicians to establish patient eligibility for treatment with AbbVie‘s newly approved c-Met-targeted therapy, Emrelis™ (telisotuzumab vedotin-tllv).
The VENTANA MET (SP44) RxDx Assay detects the MET, or c-Met, protein, which is overexpressed in about 25% of advanced NSQ-NSCLC patients with EGFR wild-type. Overexpression of MET is a predictive biomarker for response likelihood to c-Met-targeted therapy.
Understanding the molecular drivers in patients with non-small cell lung cancer is critical for therapy selection,
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.
Matt Sause
The FDA approval is supported by AbbVie’s Phase 2 LUMINOSITY clinical study data, in which the assay was employed as the enrollment test. In the study, patients with elevated MET protein expression (≥50% tumor cells with strong (3+) membrane and/or cytoplasmic staining) who were treated with Emrelis had an overall response rate (ORR) of 35% and a median duration of response (DoR) of 7.2 months.
The VENTANA MET (SP44) RxDx Assay is read by pathologists according to tumor cell staining percentage and staining intensity. The IHC test reports important data regarding MET protein expression, which will alert clinicians to the probability that a patient can be helped by c-Met-targeted therapy, thus enabling more personalized management of NSQ-NSCLC.
Lung cancer continues to be the most cancer-related death globally, with non-small cell lung cancer being responsible for about 85% of all lung cancer. The approval of this companion diagnostic is a major milestone in personalized medicine, facilitating more informed clinical choices and potentially better patient outcomes.
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