The U.S. Food and Drug Administration has approved AbbVie‘s EMRELIS™ (telisotuzumab vedotin-tllv) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression. This is a major breakthrough, with EMRELIS™ being the first and sole therapy to be approved for this particular category of patients who have already received systemic therapy.
The approval is a welcome ray of hope for patients suffering from this aggressive lung cancer, in which the c-Met protein is overexpressed in nearly 25% of advanced EGFR wild-type, non-squamous NSCLC patients and is associated with a worse prognosis. High c-Met protein overexpression is defined as ≥ 50% of tumor cells having strong (3+) staining by an FDA-approved test.
This regulatory mark is grounded on the encouraging overall response rate (ORR) and duration of response (DOR) seen within clinical trials. Yet further approval for EMRELIS™ could depend on the confirmation and definition of clinical benefit in a confirmatory trial.
The key data underpinning the FDA approval is from the Phase 2 LUMINOSITY trial. In previously treated patients with high c-Met protein overexpression, the trial showed a 35% ORR and a median DOR of 7.2 months.
In addition to the drug approval, the FDA has also approved the Roche VENTANA® MET (SP44) RxDx Assay. This diagnostic assay will be essential for determining which patients are suitable for treatment with EMRELIS™.
The most common adverse reactions in ≥20% of patients during trials were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema.
The journey of EMRELIS™ continues, as it is now in further evaluation in the Phase 3 TeliMET NSCLC-01 study, seeking to establish its clinical value and increase its possible impact in the battle against non-small cell lung cancer.
LUMINOSITY Trial Details
The goal of the ongoing Phase 2 LUMINOSITY trial (NCT03539536) is to determine which target NSCLC populations overexpress c-Met and are most appropriate for telisotuzumab vedotin-tllv monotherapy in the second- or third-line setting. The groups will then be expanded to assess efficacy in the chosen populations further. Overall survival (OS), progression-free survival (PFS) per independent central review (ICR), duration of response (DOR), disease control rate (DCR), and overall response rate (ORR) are among the endpoints. 2.
Last Modified:
Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
