AbbVie Seeks FDA Approval for Telisotuzumab Vedotin in Advanced NSCLC
核心洞察
AbbVie (搜索) has submitted a Biologics License Application to the FDA for telisotuzumab vedotin (Teliso-V) to treat non-small cell lung cancer.
The application targets patients with previously treated, locally advanced or metastatic EGFR (搜索) wild type, nonsquamous NSCLC (搜索) with c-Met protein (搜索) overexpression.
The submission is supported by Phase 2 LUMINOSITY trial data, with ongoing Phase 3 trials further evaluating Teliso-V's efficacy.
AbbVie (搜索) has announced the 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 (搜索)) wild type, nonsquamous non-small cell lung cancer (NSCLC (搜索)) with c-Met protein (搜索) overexpression.
Approximately 85% of lung cancers are classified as NSCLC (搜索), remaining the leading cause of cancer-related deaths worldwide. The c-Met protein (搜索), a receptor tyrosine kinase, is overexpressed in roughly 25% of advanced EGFR (搜索) wild type, nonsquamous NSCLC patients and is associated with a poor prognosis. Teliso-V is being evaluated as a potential treatment for this patient population, which currently has limited treatment options.
Targeting c-Met Overexpression in NSCLC
Teliso-V is an investigational, first-in-class, c-Met protein (搜索)-directed antibody-drug conjugate (ADC) designed to target c-Met overexpressing tumors. c-Met is a receptor tyrosine kinase that can be overexpressed in various solid tumors, including NSCLC (搜索). The overexpression of c-Met is linked to poorer outcomes in NSCLC patients, making it a key target for novel therapies.
Supporting Data from the LUMINOSITY Trial
The BLA submission is supported by data from the Phase 2 LUMINOSITY trial (Study M14-239), an ongoing study characterizing the safety and efficacy of Teliso-V in c-Met overexpressing NSCLC (搜索) populations. The LUMINOSITY trial is designed to identify the target NSCLC populations that overexpress c-Met best suited for Teliso-V monotherapy in the second- or third-line setting and then to expand the groups to further evaluate efficacy in the selected populations. 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).
Ongoing Phase 3 Trial
Teliso-V is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC (搜索) in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites.
Addressing Unmet Needs in NSCLC Treatment
"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 (搜索). "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."