AbbVie’s Emrelis is the first non-small cell lung cancer therapy approved for patients with high c-Met expression levels who have received prior lines of treatment.
The FDA signed off on AbbVie’s antibody-drug conjugate telisotuzumab vedotin for the treatment of certain types of lung cancer on Wednesday. The biologic will carry the brand name Emrelis.
Emrelis is indicated for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high expression levels of the c-Met protein. The FDA cleared Emrelis under its accelerated pathway, though the drug’s continued approval could depend on further confirmatory studies that validate its clinical benefit.
NSCLC is the most common form of lung cancer, accounting for some 85% of patients with this type of malignancy, according to AbbVie’s statement announcing the approval. The c-Met protein, a receptor tyrosine kinase involved in various cellular signaling pathways, is overexpressed in a substantial portion of NSCLC patients, worsening their prognoses. Emrelis is the first and so far only therapy approved for patients with advanced NSCLC who have high c-Met expression and have undergone prior lines of therapy, AbbVie said.
Emrelis is also AbbVie’s first solid tumor approval in lung cancer, CSO Roopal Thakkar said in a statement, adding that the biologic can “improve the course of treatment for patients facing this challenging disease.”
Wednesday’s approval is backed by data from the Phase II LUMINOSITY trial. A topline readout in December 2023 showed that Emrelis elicited a 35% overall response rate (ORR) in NSCLC patients with high c-Met expression. In those with intermediate expression levels of the protein, ORR hit 23%. On Wednesday, AbbVie also touted a median response duration of 7.2 months in this patient subgroup.
On top of LUMINOSITY, the pharma is also running a Phase III study of Emrelis testing the drug as a monotherapy in NSCLC patients with c-Met overexpression, dubbed TeliMET NSCLC-01. Enrollment into TeliMET NSCLC-01, which will serve as Emrelis’ confirmatory study, is ongoing.
The approval of Emrelis comes as AbbVie ramps up its cancer push in recent weeks. In January, the pharma inked a potential $1.64 billion deal with Neomorph for its expertise in molecular glue degraders, which the partners will leverage against multiple oncology and immunology targets. A few weeks later, AbbVie put $2.1 billion on the line in an agreement with Xilio Therapeutics to develop T cell therapies targeting the tumor microenvironment.
This week, AbbVie dove deeper into a third novel anti-cancer modality. With a $335 million upfront payment and the promise of “several billion dollars” in milestones, the company partnered with ADARx to develop siRNA medicines for oncology, immunology and neuroscience targets.
