This application aims to provide a new treatment option for adult patients who have priorly treated, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is epidermal growth factor receptor (EGFR) wild type and nonsquamous, with c-Met protein overexpression.
The BLA submission is underpinned by positive results from the Phase II LUMINOSITY trial, assessing the safety and efficacy of Teliso-V in c-Met overexpressing NSCLC populations.
The trial was designed to first identify NSCLC patients most likely to benefit from Teliso-V monotherapy, and then to expand the cohort to further evaluate the treatment’s efficacy.
Key metrics of the trial include overall response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS), as determined by independent central review (ICR).
In the trial, an overall response rate of 35% was observed in c-Met High patients and 23% in c-Met Intermediate patients.
Other significant outcomes from the trial include median duration of response of nine months and 7.2 months, and a median overall survival of 14.6 months and 14.2 months for c-Met High and c-Met Intermediate patients, respectively.
An investigational antibody-drug conjugate (ADC) Teliso-V is specifically designed to target tumours that overexpress the c-Met protein, a receptor tyrosine kinase implicated in various solid tumours, including NSCLC.
In December 2021, Teliso-V received the breakthrough therapy designation from the FDA.
The product is currently being evaluated as a monotherapy in the Phase III TeliMET NSCLC-01 confirmatory trial in patients with previously treated c-Met overexpressing NSCLC.
Enrolment for this study is ongoing at clinical trial sites worldwide.
AbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar said: “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.
“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.”