An investigational antibody-drug conjugate (ADC), Teliso-V targets c-Met receptor tyrosine kinase that is overexpressed in tumours that include NSCLC.
It is indicated to treat nonsquamous NSCLC patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, high levels of c-Met overexpression whose disease progressed after platinum-based therapy.
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 approval was based on data obtained from the ongoing Phase II LUMINOSITY (M14-239) study that is designed to target patients with NSCLC who are eligible for Teliso-V monotherapy.
The overall response rate (ORR) per central review in patients with follow-up for at ≥ 12 weeks is the trials’ primary goal.
As per the interim analysis, Teliso-V showed an ORR of 53.8% in the c-Met high group and 25% in the c-Met intermediate group, among the participants in the study with EGFR WT nonsquamous NSCLC.
Additionally, the therapy is being assessed in the ongoing Phase I study M14-237, along with osimertinib, in previously treated c-Met overexpressing NSCLC patients.
It will also be studied in patients with previously treated c-Met overexpressing NSCLC, as monotherapy, in the randomised Phase III TeliMET NSCLC-01 study.