NSCLC is the most common type of lung cancer and accounted for approximately 85% of all lung cancers. The c-MET protein is overexpressed in around 32% of patients with advanced NSCLC.

In May 2025, the US FDA approved EMRELIS (telisotuzumab vedotin-tllv) for the treatment of adult patients with locally advanced or metastatic, non-squamous NSCLC with high c-MET protein Overexpression (OE) who have received a prior systemic therapy. The FDA accelerated approval was supported by data from the Phase II LUMINOSITY study, a study designed to characterize the efficacy and safety of EMRELIS in c-MET overexpressing advanced NSCLC populations. AbbVie is currently conducting a Phase III confirmatory trial, TeliMET NSCLC-01, evaluating Emrelis in patients with c-Met-overexpressing NSCLC. This study compares the ADC directly against the standard chemotherapy agent docetaxel.

The ASCO 2025 has brought pivotal results of the Phase II LUMINOSITY study with a cut off date of 21 Feb 2024.

Among the 172 dosed patients, the most common any-grade Treatment-related Adverse Events (TRAEs) were peripheral sensory neuropathy (31%), peripheral edema (16%), and fatigue (14%). The most common grade USD 3 TRAE was peripheral sensory neuropathy (7%).

KOL insights

“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 [telisotuzumab vedotin] is a first-in-class antibody drug conjugate [ADC] that can address a critical unmet need for this patient population.” – Expert opinion.

‘The primary end point of LUMINOSITY was the objective response rate in the c-MET–high group. It was 35%, so it was meaningfully superior to 2 other FDA-approved agents in the second-line setting.” – Expert opinion

Conclusion

EMRELIS is approved for previously treated advanced NSCLC patients with high c-MET protein overexpression. The analysis showed that EMRELIS produced lasting responses in patients with c-MET protein–overexpressing, EGFR–wild-type nonsquamous NSCLC, regardless of prior treatment with platinum alone or in combination with immunotherapy.  TABRECTA (capmatinib) and TEPMETKO (tepotinib), two already FDA-approved and highly specific small-molecule inhibitors of c-MET exon 14 skipping mutations are new and important therapeutic options for the treatment of NSCLC patients harbouring c-MET alterations. TABRECTA is expected to continue its market-leading position in first-line c-MET NSCLC thanks to its first-to-market advantage over TEPMETKO. By 2034, EMRELIS is projected to generate approximately USD 1 billion in sales across the 7MM.