AbbVie has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.

Approximately 85 percent of lung cancers are classified as NSCLC1 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world. 

The c-Met protein is a receptor tyrosine kinase found to be overexpressed in approximately 25 percent of advanced EGFR wild type, nonsquamous NSCLC patients and is associated with a poor prognosis.

Teliso-V is being evaluated within this patient population who currently have very limited treatment options. 

"Patients with non-small cell lung cancer have unmet medical needs and oncologists are looking for new treatment options for these patients who unfortunately have a poor prognosis," said Roopal Thakkar, MD, Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie.

"We are hopeful that Teliso-V will be a differentiated treatment for certain patients as we look to elevate the standards of care in oncology," Thakkar added.

In December 2021, Teliso-V was granted Breakthrough Therapy Designation by the FDA. The BLA submission is supported by data from Phase 2 LUMINOSITY trial (Study M14-239), an ongoing study designed to characterize the safety and efficacy of Teliso-V in c-Met overexpressing NSCLC populations.

Data from the LUMINOSITY study were recently presented at the 2024 American Society of Clinical Oncology congress and topline data from this trial were shared in 2023.

Teliso-V is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites.