AbbVie Submits FDA Application for Teliso-V in Treated NSCLC

AbbVie has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for telisotuzumab vedotin (Teliso-V). This application targets adult patients with previously treated, locally advanced, or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) that overexpresses the c-Met protein.

Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancers and is the leading cause of cancer-related deaths globally. Despite advancements in treatment, there remain significant unmet needs, especially among those whose cancer overexpresses the c-Met protein. Approximately 25% of patients with advanced EGFR wild type, nonsquamous NSCLC exhibit c-Met protein overexpression, which is linked to poor prognoses. Teliso-V is under evaluation to address this patient population that currently has limited treatment options.

Roopal Thakkar, M.D., AbbVie's executive vice president of research and development and chief scientific officer, emphasized the critical need for new treatments for non-small cell lung cancer patients. "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 Thakkar. He expressed hope that Teliso-V could offer a differentiated treatment to improve oncology care standards.

The BLA submission is bolstered by data from the ongoing Phase 2 LUMINOSITY trial (Study M14-239). This study aims to assess the safety and efficacy of Teliso-V in NSCLC populations with c-Met overexpression. Data from the LUMINOSITY trial were recently presented at the 2024 American Society of Clinical Oncology congress, with topline data shared in 2023. Teliso-V is also being tested as a monotherapy in a randomized Phase 3 global confirmatory study named TeliMET NSCLC-01, which is currently enrolling patients worldwide.

Telisotuzumab vedotin, also known as Teliso-V, is an investigational, first-in-class antibody-drug conjugate (ADC) designed to target tumors that overexpress the c-Met protein. c-Met is a receptor tyrosine kinase overexpressed in various solid tumors, including NSCLC. Teliso-V has not yet received approval from any health regulatory authority.

The LUMINOSITY trial (M14-239) is a Phase 2 study designed to pinpoint the NSCLC populations that most effectively respond to Teliso-V monotherapy in second-line or third-line treatment settings. The study’s endpoints include overall response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) as assessed by independent central review.

AbbVie remains committed to transforming care standards for patients with hard-to-treat cancers. The company is advancing a dynamic pipeline of investigational therapies for a variety of cancer types, including both blood cancers and solid tumors. AbbVie focuses on developing targeted treatments that either inhibit cancer cell reproduction or facilitate their destruction. This is achieved through different treatment modalities, such as antibody-drug conjugates (ADCs), immuno-oncology, bi-specific antibodies, and CAR-T platforms. AbbVie collaborates with innovative partners to expedite the delivery of potential breakthrough medicines.

The company’s oncology portfolio includes both approved and investigational treatments across a wide range of blood and solid tumors. More than 20 investigational medicines are currently under evaluation in multiple clinical trials targeting some of the world's most prevalent and debilitating cancers. AbbVie is dedicated to finding solutions to help patients gain access to its cancer medicines.

AbbVie's mission is to develop and deliver innovative medicines to address serious health issues and future medical challenges. The company aims to significantly impact people’s lives in key therapeutic areas such as immunology, oncology, neuroscience, and eye care, in addition to its Allergan Aesthetics products and services.