The FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv), a targeted therapy for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) marked by high c-Met protein overexpression.
This is the first approved treatment for this patient group, who often face limited options and poor outcomes after standard therapies fail.
NSCLC accounts for the majority of lung cancer cases. In a subset of patients, cancer cells produce unusually high levels of the c-Met protein (short for mesenchymal-epithelial transition factor), which supports cell growth and survival.
When overexpressed, c-Met is linked to aggressive tumors and resistance to conventional treatments.
About 25% of patients with epidermal growth factor receptor (EGFR) wild-type NSCLC show c-Met overexpression, and roughly half of them meet the threshold for high expression.
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Emrelis is an antibody-drug conjugate (ADC) that delivers a microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a cleavable linker. It combines a c-Met–targeting antibody with a chemotherapy payload that disrupts tumor cell division. By binding selectively to cells with high c-Met expression, the drug concentrates its effects on cancer cells while limiting damage to healthy tissue.
Although MET protein overexpression occurs in approximately 20% to 25% of NSCLC cases, not all tumors are functionally dependent on the c-Met pathway — an important factor that may influence treatment response.
The FDA also approved the VENTANA MET (SP44) RxDx Assay as a companion diagnostic. Used in the LUMINOSITY trial, this immunohistochemistry-based test detects MET protein expression in tumor tissue. Pathologists assess staining intensity and the percentage of tumor cells with strong membrane or cytoplasmic staining; high c-Met overexpression is defined as expression in at least 50% of tumor cells.
Emrelis’ approval was based on data from the Phase II LUMINOSITY trial, which enrolled 84 patients with previously treated, EGFR wild-type NSCLC and high c-Met overexpression. Participants received telisotuzumab vedotin-tllv as an intravenous infusion every two weeks. The trial showed a 35% overall response rate, with a median duration of response of 7.2 months, based on independent central review.
The most common side effects in the pooled safety population included peripheral neuropathy, fatigue, decreased appetite and peripheral edema. Emrelis also carries warnings for potential lung complications, infusion-related reactions, eye problems and nerve damage.
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AbbVie is continuing to evaluate the drug in the global Phase III TeliMET NSCLC-01 trial. Emrelis is the company’s first FDA-approved solid tumor therapy in lung cancer and marks a milestone in its strategy to expand targeted options for difficult-to-treat cancers.
Across the NSCLC market, Daiichi Sankyo and AstraZeneca’s investigational ADC datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy designation in late 2024 for adults with locally advanced or metastatic NSCLC that progressed after an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
And currently in preclinical trials, companies like EpiBiologics are pursuing an alternative strategy for bispecific antibodies: degrading the c-Met protein entirely rather than simply blocking it. This approach has shown sustained tumor suppression in NSCLC models, including tumors with low c-Met expression or limited c-Met dependence.
Other key players in the NSCLC space include Merck, Pfizer, Gilead Sciences, Sanofi and BioNTech.
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