On September 27, 2024 AbbVie (NYSE: ABBV) reported submission of a Biologics License Application (BLA) to the U.S. 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 (Press release, AbbVie, SEP 27, 2024, View Source [SID1234646901]).

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Approximately 85% 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.2 The c-Met protein is a receptor tyrosine kinase found to be overexpressed in approximately 25% of advanced EGFR wild type, nonsquamous NSCLC patients3 and is associated with a poor prognosis.4,5,6 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, M.D., 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."

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 (ASCO) (Free ASCO Whitepaper) 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. Additional information on clinical trials for Teliso-V is available at www.clinicaltrials.gov.

About Telisotuzumab Vedotin (Teliso-V)
Teliso-V is an investigational, first-in-class, c-Met protein directed antibody-drug conjugate (ADC) designed to target c-Met overexpressing tumors. c-Met is a receptor tyrosine kinase that can be overexpressed in many solid tumors including NSCLC. Further information on clinical trials for Teliso-V is available at View Source Teliso-V is not approved by any health regulatory authority.

About the LUMINOSITY Trial
The LUMINOSITY trial (M14-239), is an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for Teliso-V monotherapy in the second-line or third-line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The endpoints include overall response rate (ORR), duration of response (DoR), disease control rate (DCR) and progression-free survival (PFS) per independent central review (ICR) as well as overall survival (OS).