Teliso-V Advances to FDA Review as AbbVie Pursues Accelerated Pathway for c-Met Overexpressing Lung Cancers

AbbVie has filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration for telisotuzumab vedotin (Teliso-V), seeking accelerated approval for a previously underserved patient population with advanced non-small cell lung cancer (NSCLC). The filing targets adult patients with locally advanced or metastatic disease who have exhausted initial treatment options and possess specific c-Met protein overexpression characteristics.

Addressing an Unmet Medical Challenge

Non-small cell lung cancer represents approximately 85% of all lung cancer diagnoses, yet remains the leading cause of cancer-related mortality worldwide. Within this cohort, a distinct subset—approximately 25% of patients with EGFR wild-type, nonsquamous NSCLC—exhibits c-Met protein overexpression, a molecular marker strongly associated with aggressive disease progression and poor clinical outcomes. Currently, no anti-cancer therapies have been specifically designed to address this c-Met-driven population, positioning Teliso-V as a potential first-in-class therapeutic solution.

The c-Met receptor, a tyrosine kinase frequently dysregulated in solid tumors, functions as a critical driver of uncontrolled cell proliferation in certain lung cancer subtypes. Patients whose tumors display this molecular signature face particularly limited treatment alternatives following standard-of-care chemotherapy or targeted therapies, creating a genuine therapeutic gap.

Product Mechanism and Design Strategy

Teliso-V represents an investigational antibody-drug conjugate (ADC), a targeted treatment modality engineered to recognize and eliminate c-Met overexpressing tumor cells. This directed approach enables the molecule to selectively engage cancer cells bearing elevated c-Met levels while potentially minimizing systemic exposure, a characteristic feature of modern ADC platform technology.

The December 2021 Breakthrough Therapy Designation from the FDA underscores regulatory recognition of Teliso-V’s potential clinical significance for this patient population. The accelerated review pathway under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) program expedites evaluation while maintaining rigorous safety and efficacy scrutiny.

Clinical Evidence Supporting BLA Submission

The BLA filing draws support from the Phase 2 LUMINOSITY trial (Study M14-239), an ongoing investigation designed to characterize Teliso-V’s safety profile and therapeutic efficacy in c-Met overexpressing NSCLC populations. Recent data presentations at the 2024 American Society of Clinical Oncology congress provided updated efficacy signals, with preliminary results disclosed during 2023.

LUMINOSITY’s study design identifies which NSCLC populations with c-Met overexpression derive optimal benefit from Teliso-V monotherapy in second-line or third-line treatment settings. The trial measures multiple clinically relevant endpoints including overall response rate (ORR), duration of response (DoR), disease control rate (DCR), and progression-free survival (PFS) via independent central review, alongside overall survival (OS) assessments.

Concurrent advancement occurs through the randomized Phase 3 TeliMET NSCLC-01 confirmatory study, which continues enrolling patients globally to further establish Teliso-V’s efficacy as monotherapy in the previously treated c-Met overexpressing NSCLC setting.

Strategic Positioning Within Oncology

Dr. Roopal Thakkar, Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie, noted that oncologists urgently seek differentiated treatment options for NSCLC patients facing limited prognosis. The company views Teliso-V as a potential therapeutic advance capable of elevating standards of care within specific patient populations defined by molecular characteristics rather than histologic patterns alone.

AbbVie’s oncology strategy emphasizes targeted medicine development across blood cancers and solid tumors. The company actively evaluates more than 20 investigational molecules in ongoing clinical trials across prevalent and debilitating malignancies. The therapeutic toolkit spans multiple platforms including antibody-drug conjugates, immuno-oncology agents, bi-specific antibodies, and CAR-T cell therapies, each offering distinct mechanisms for either suppressing cancer cell reproduction or facilitating their elimination.

Regulatory Pathway and Next Steps

The FDA will conduct BLA review through its specialized Oncology Center of Excellence, applying Real-Time Oncology Review procedures designed for promising oncology candidates. This pathway balances expedited access with comprehensive safety evaluation. Patients and providers can access detailed trial enrollment information through www.clinicaltrials.gov.

Should regulatory authorization materialize, Teliso-V would become the first approved therapeutic specifically targeting c-Met overexpression in NSCLC, potentially transforming treatment options for patients whose tumors display this molecular signature.