Benzinga | Jan 4, 2022 08:16AM EST

AbbVie Reports FDA Granted Breakthrough Therapy Designation To Telisotuzumab Vedotin For Previously-Treated Non-Small Cell Lung Cancer

LUMINOSITY (M14-239) is ongoing, and the Phase 3 study TeliMET NSCLC-01 (M18-868) is planned to begin in the first half of 2022

- There are currently no approved cancer therapies specifically for patients with c-Met overexpressing NSCLC

- This is the first BTD for an AbbVie solid tumor investigational therapy, adding to 10 BTDs across AbbVie's blood cancer leadership portfolio

NORTH CHICAGO, Ill., Jan. 4, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy.

The FDA's BTD program is intended to expedite the development and review of medicines with preliminary clinical evidence that indicate that the investigational treatment may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.1

Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths in both men and women in the U.S. and throughout the world. It is the most common cancer in males and the third most common cancer in females worldwide, with incidence rates (per 100,000) of 31.5 and 14.6, respectively.2 Approximately 85% of lung cancers are classified as NSCLC.3 Patients whose disease progresses after standard of care therapies, including prior platinum, have limited treatment options and poor prognosis.

"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," said Mohamed Zaki, M.D., Ph.D., Vice President and Global Head of Oncology Clinical Development at AbbVie. "Today's announcement marks an important step in our mission to advance new oncology treatments across tumor types to improve standards of care for patients with cancer."

This BTD designation is supported by data from LUMINOSITY (Study M14-239), an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for Teliso-V monotherapy in the second line or third line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The primary endpoint is overall response rate (ORR) per central review in patients with ? 12 weeks follow-up. Among patients with EGFR WT nonsquamous NSCLC, ORR was 53.8% in the c-Met high group and 25.0% in the c-Met intermediate group at a previously reported interim analysis. Teliso-V is also being evaluated in combination with osimertinib in the ongoing Phase 1 study M14-237 in patients with previously treated c-Met overexpressing NSCLC. In addition, it will be further evaluated as monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 study TeliMET NSCLC-01 (Study M18-868).

AbbVie will present Teliso-V data at upcoming scientific congresses. Additional information on clinical trials for Teliso-V is available at www.clinicaltrials.gov.

Teliso-V is an investigational antibody-drug conjugate (ADC) targeting c-Met, a receptor tyrosine kinase that is overexpressed in tumors including NSCLC. Teliso-V is not approved by any regulatory authority and its safety and efficacy have not been established. Currently there are no approved cancer therapies specifically for patients with c-Met overexpressing NSCLC.