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The US Food and Drug Administration (FDA) has granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie) for locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy. 

The FDA also approved the VENTANA MET (SP44) RxDx Assay (Roche Diagnostics) as a companion diagnostic to detect high c-Met protein overexpression, defined as 50% or more of tumor cells with 3+ staining.

The antibody-drug conjugate consists of a c-Met–directed antibody and microtubule inhibitor conjugate. 

Telisotuzumab vedotin-tllv “is the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression who often face poor prognosis and have limited treatment options,” AbbVie said in a press release. 

C-Met is a cell surface protein that is overexpressed in approximately 25% of patients with advanced epidermal growth factor receptor (EGFR) wild-type, nonsquamous NSCLC, driving tumor progression. Roughly half of overexpressors have high c-Met expression.

Approval was based on the phase 2 LUMINOSITY trial in 84 patients with EGFR wild-type, nonsquamous NSCLC and high c-Met protein overexpression. Patients received telisotuzumab vedotin-tllv as monotherapy in the second or third-line setting.

The overall response rate was 35%, and the median duration of response was 7.2 months. 

The most common adverse reactions, in 20% or more of study participants, were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common grade 3 or 4 laboratory abnormalities, in 2% of more of participants, were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.

The recommended telisotuzumab vedotin-tllv dose is 1.9 mg/kg intravenously up to a maximum of 190 mg for patients who weigh 100 kg or more every 2 weeks until disease progression or unacceptable toxicity.

The treatment is being further evaluated in the phase 3 trial TeliMET, AbbVie noted in the press release.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com