The FDA has granted accelerated approval to Telisotuzumab vedotin for the treatment of patients with locally advanced or metastatic, nonsquamous non-small cell lung cancer with high c-MET protein overexpression. This approval is based on the study showing an overall response rate of 35%. Around 25% of patients with advanced EGFR wild-type NSCLC shows C-MET protein overexpression and about half on those have at least 50% of tumor cells.
Emrelis is a novel antibody drug conjugate (ADC) and it consists of an antibody targeting c-MET. This is a receptor tyrosine kinase and is responsible for promoting cell growth along with topoisomerase inhibitor chemotherapy drug. This new approval is supported by findings from the Phase II LUMINOSITY trial which included 84 people with EGFR wild-type NSCLC who had previously been treated with at least one systemic therapy. In this study, the participants received Emrelis via IV infusion every two weeks. The overall response rate was 35%, indicating tumor shrinkage. The therapies that received accelerated approval was based on these endpoints undergo further testinh to determine their clincial benefits. The recommended Telisotuzumab vedotin-tllv dose is 1.9 mg/kg as an intravenous infusion every two weeks, until disease progression or unacceptable toxicity.
“Despite the progress we have seen in the treatment of lung cancer, we need more options for people whose treatments stop working,” said LUNGevity Foundation executive director Upal Basu Roy, PhD, MPH. “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.”
Emrelis is now being further evaluated in a global randomized Phase III confirmatory trial called TeliMET NSCLC-01.
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