The FDA has granted accelerated approval to AbbVie’s Emrelis (telisotuzumab vedotin-tllv) for the treatment of adults with previously treated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) exhibiting high c-Met protein overexpression, as determined by an FDA-approved immunohistochemistry test. According to the company, Emrelis—a c-Met-directed antibody-drug conjugate (ADC)—is the only treatment approved for this subset of NSCLC patients. Approval was based on results from the Phase II LUMINOSITY trial.¹

"We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes," said Jonathan Goldman, MD, professor, medicine, director, thoracic oncology clinical trials, UCLA, in a 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."

What Were the Response Rates from the LUMINOSITY Trial Supporting Emrelis' Approval?

The ongoing open-label LUMINOSITY study is evaluating the safety and efficacy of Emrelis as a monotherapy in the second- or third-line setting in 270 patients. The primary endpoint of the study was overall response rate (ORR) per RECIST 1.1 criteria, as assessed by blinded independent central review. Key secondary endpoints included duration of response (DOR), disease control rate, progression-free survival, and overall survival.^1,2

Results showed an ORR of 35% and a median DOR of 7.2 months in patients with high c-Met expression. Common adverse events included peripheral neuropathy, fatigue, and decreased appetite. Additionally, common grade 3 or 4 laboratory abnormalities included decreased lymphocytes; increased glucose; elevated alanine aminotransferase; elevated gamma-glutamyl transferase; decreased phosphorus; decreased sodium; decreased hemoglobin; and decreased calcium.¹

"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," said Roopal Thakkar, MD, EVP, research and development, chief scientific officer, AbbVie, in the press release. "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."

Lung Cancer Remains Leading Cause of US Cancer Deaths

According to the Centers for Disease Control and Prevention, lung cancer is the third most common cancer in the United States. Notably, it causes more deaths than any other type of cancer nationwide.³ The American Cancer Society estimates that by the end of 2025, there will be approximately 226,650 new cases of lung cancer and 124,730 deaths. Most people diagnosed with the disease are over 65 years of age, while only a small percentage are diagnosed before age 45. The median diagnosis age is 70 years.⁴

"Despite the progress we have seen in the treatment of lung cancer, we need more options for people whose treatments stop working," said Upal Basu Roy, PhD, MPH, executive director, research, LUNGevity Foundation, a lung cancer nonprofit organization, in the press release. "This approval is a welcomed targeted therapy for those with high c-Met protein overexpressing late-stage, non-small cell lung cancer who have seen very limited treatment innovation in the last decade."

Ongoing Phase III Trial Aims to Confirm Clinical Benefit

Emrelis previously received Breakthrough Therapy designation and is currently being studied in the ongoing Phase III TeliMET NSCLC-01 trial to confirm clinical benefit. As a companion diagnostic, the FDA also approved Roche’s Ventana MET (SP44) RxDx Assay.¹

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. AbbVie. May 14, 2025. Accessed May 15, 2025. https://news.abbvie.com/2025-05-14-U-S-FDA-Approves-EMRELIS-TM-telisotuzumab-vedotin-tllv-for-Adults-With-Previously-Treated-Advanced-Non-Small-Cell-Lung-Cancer-NSCLC-With-High-c-Met-Protein-Overexpression

2. Study of Telisotuzumab Vedotin (ABBV-399) in Participants with Previously Treated c-Met+ Non-Small Cell Lung Cancer. Clinicaltrials.gov. Accessed May 15, 2025. https://clinicaltrials.gov/study/NCT03539536

3. Lung Cancer Statistics. CDC. Accessed May 15, 2025. https://www.cdc.gov/lung-cancer/statistics/index.html

4. Key Statistics for Lung Cancer. American Cancer Society. Accessed May 15, 2025. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html