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).
In the press release, Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie, added: "Emrelis, AbbVie's first internally developed solid tumor medicine and our first solid tumor FDA approval in lung cancer, is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease. Leveraging advanced technology and data science, we are growing our ADC portfolio designed to deliver the right medicines to the right patients in need across a range of difficult-to-treat tumors."
AbbVie originally shared topline results from LUMINOSITY in November 2023. Along with its marks in ORR and DOR, Emrelis showed a median OS of 14.6 months for c-Met High patients and 14.2 for c-Met Intermediate. Its safety profile was consistent with previously reported clinical data and no new concerns were identified.3
In a press release from the time, Ross Camidge, MD, PhD, University of Colorado Cancer Center, United States, and principal investigator for the trial, said: "The results of the Phase II LUMINOSITY trial are encouraging for those patients with non-small cell lung cancer with c-Met overexpression as there is a critical need for better care and additional therapy options for them. "Today's announcement also provides confidence as we continue to enroll patients into the Phase III TeliMET NSCLC-01 trial and expand our understanding of Teliso-V's potential."
The FDA originally granted Emrelis Breakthrough Therapy Designation based on LUMINOSITY data in December 2021. As mentioned by Camidge, the ADC is also being evaluated in the Phase III confirmatory global study TeliMET NSCLC-01 as monotherapy in patients with previously treated c-Met overexpressing NSCLC. Enrollment in the trial is still underway.
References
1. U.S. FDA Approves EMRELIS™ (telisotuzumab vedotin-tllv) for Adults With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) With High c-Met Protein Overexpression. News release. AbbVie. May 14, 2025. Accessed May 15, 2025. https://www.prnewswire.com/news-releases/us-fda-approves-emrelis-telisotuzumab-vedotin-tllv-for-adults-with-previously-treated-advanced-non-small-cell-lung-cancer-nsclc-with-high-c-met-protein-overexpression-302455629.html
2. Key Statistics for Lung Cancer. American Cancer Society. Accessed May 15, 2025. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html
3. AbbVie Announces Positive Topline Results from Phase 2 LUMINOSITY Trial Evaluating Telisotuzumab-Vedotin (Teliso-V) for Patients with Previously Treated Non-Small Cell Lung Cancer (NSCLC). News release. AbbVie. November 29, 2023. Accessed May 15, 2025. https://news.abbvie.com/2023-11-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-2-LUMINOSITY-Trial-Evaluating-Telisotuzumab-Vedotin-Teliso-V-for-Patients-with-Previously-Treated-Non-Small-Cell-Lung-Cancer-NSCLC
