The breakthrough therapy designation was granted based on data from LUMINOSITY, an ongoing Phase 2 study structured to identify the NSCLC populations eligible for Teliso-V monotherapy
AbbVie has received the US Food and Drug Administration (FDA) breakthrough therapy designation (BTD) for telisotuzumab vedotin (Teliso-V) to treat a type of non-small cell lung cancer (NSCLC).
Teliso-V is an investigational antibody-drug conjugate (ADC) that targets c-Met, a receptor tyrosine kinase that is overexpressed in tumours.
It was indicated for NSCLC patients with advanced epidermal growth factor receptor (EGFR) wild type, with c-Met overexpression, and previously treated platinum-based therapy.
The FDA’s BTD programme is aimed at advancing the development and review of medicines that show promising results in a substantial improvement over existing therapies.
AbbVie vice president and oncology clinical development global head Mohamed Zaki said: “Patients with non-small cell lung cancer have a high unmet need and Teliso-V has the potential to provide them with an additional treatment option to manage their disease.
“Today’s announcement marks an important step in our mission to advance new oncology treatments across tumour types to improve standards of care for patients with cancer.”
The FDA granted BTD based on data from LUMINOSITY, an ongoing Phase 2 study structured to identify the NSCLC populations eligible for Teliso-V monotherapy.
The study has met the primary endpoint of overall response rate (ORR) per central review in patients with follow-up for at least 12 weeks.
In the study participants with EGFR WT non-squamous NSCLC, the treatment resulted in an ORR of 53.8% in the c-Met high group, and 25% in the c-Met intermediate group.
Also, Teliso-V is being studied in an ongoing Phase 1 study, in combination with Osimertinib, in patients with previously treated c-Met overexpressing NSCLC.
AbbVie intends to further evaluate the drug as monotherapy in patients with previously treated c-Met overexpressing NSCLC in the Phase 3 TeliMET NSCLC-01 trial.
The company noted that its Teliso-V has not been approved by any regulatory authority and its safety and efficacy have not been validated yet.