Key takeaways
1. Accelerated approval based on Phase II data: Emrelis received FDA accelerated approval for c-Met high NSCLC based on ORR and DOR results from the Phase II LUMINOSITY trial.
2. Focus on biomarker-driven therapies: This approval reinforces the growing clinical emphasis on personalized, biomarker-targeted treatments, especially in populations with limited options.
3. Ongoing development in Phase III: The confirmatory Phase III TeliMET NSCLC-01 trial is currently enrolling, aiming to validate Emrelis’ benefit and support full regulatory approval.
The FDA has granted accelerated approval to AbbVie’s Emrelis (telisotuzumab vedotin-tllv), a first-in-class c-Met-directed antibody-drug conjugate (ADC), for the treatment of adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy. This indication is approved based on overall response rate (ORR) and duration of response (DOR) demonstrated by Emrelis in the Phase II LUMINOSITY clinical trial.1
Clinical significance
In a press release, Jonathan Goldman, MD, professor of medicine, director of thoracic oncology clinical trials, UCLA, said: "We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes. 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."
According to estimates from the American Cancer Society, there will be about 226,650 new cases of lung cancer across the US in 2025. In general, about 13% of all lung cancers are small-cell lung cancer, while about 87% are NSCLC. The disease accounts for about 1 in 5 of all cancer deaths, which is by far the leading cause of cancer death in the US.2
LUMINOSITY Phase II results
In the Phase II LUMINOSITY study, Emrelis demonstrated an ORR of 35% and DOR with a median of 7.2 months in patients with high c-Met protein overexpression. LUMINOSITY is an ongoing trial evaluating the safety and efficacy of Emrelis across NSCLC populations that overexpress c-Met that are best suited for telisotuzumab vedotin-tllv monotherapy in the second- or third-line setting. In addition to ORR and DOR, other study endpoints include disease control rate, progression-free survival, and overall survival (OS).
