Roche receives USFDA approval for VENTANA MET (SP44) RxDx Assay as companion diagnostic in non-small cell lung 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 35% overall response rate (ORR) and duration of response (DoR) with a median of 7.2 months.

"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," the company stated in a release.

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. 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 ≥50% tumor cells demonstrating strong (3+) membrane and/or cytoplasmic staining.

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.