For adult patients with previously treated, advanced NSCLC with high c-Met protein overexpression, the U.S. FDA has approved treatment with Emrelis.
The United States Food and Drug Administration (FDA) has approved treatment with Emrelis for adult patients with previously treated, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression, according to a news release from AbbVie. High c-Met protein overexpression, in this case, is defined as 50% or more of tumor cells with strong (3+) staining as determined by an FDA-approved test.
Notably, this makes Emrelis the first and only antibody drug conjugate approved by the regulatory agency for patients with previously treated, advanced NSCLC who have high c-Met protein overexpression. This is important because these patients often have a poor prognosis and limited treatment options, according to the release.
“We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes,” Dr. Jonathan Goldman, stated in the press release. “People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and Emrelis is a first-in-class ADC that can address a critical unmet need for this patient population.”
Goldman is a professor of Medicine in the Hematology/Oncology Division; the director of Clinical Trials in Thoracic Oncology; and the associate director of Early Drug Development at UCLA Health; as well as the chair of University of California Lung Cancer Consortium
This accelerated approval from the regulatory agency was supported by data from the phase 2 LUMINOSITY study which aimed to characterize the efficacy and safety of Emrelis in patients with Met overexpressing advanced NSCLC. It was found that of the 84 patients with high c-Met protein overexpression who received Emrelis achieved a 35% overall response rate. Moreover, the duration of response in this patient population was 7.2 months.
Regarding safety, the most common side effects to treatment which occurred in 20% of patients or mere were peripheral neuropathy, fatigue, decreased appetite and peripheral edema. Grade 3 (severe) or 4 (life-threatening) laboratory abnormalities which occurred in 2% of patients or more included decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium.
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