FDA Grants Breakthrough Therapy Designation to Teliso-V for Treatment of NSCLC

The FDA has granted breakthrough therapy designation (BTD) to investigational telisotuzumab vedotin (Teliso-V, AbbVie) for the treatment of individuals 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.

NSCLC is defined as any type of epithelial lung cancer other than SCLC, which can include adenocarcinoma, large-cell carcinoma, and squamous cell carcinoma, as well as less common types of cancer.

"Patients with NSCLC have a high unmet need, and Teliso-V has the potential to provide them with an additional treatment option to manage their disease," Mohamed Zaki, MD, PhD, vice president and global head of Oncology Clinical Development at AbbVie, said in a company statement.1 "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.”.

Lung cancer is the leading cause of cancer-related mortality in the United States, with a 5-year relative survival rate of 21% between 2010 and 2016.2

The 5-year relative survival rate varies for individuals who were diagnosed at local stage (59%), at regional state (32%), or distant stage (6%), according to the National Cancer Institute.

Additionally, in 2021, there were an estimated 235,760 new lung cancer cases and 131,880 deaths, with both NSCLC and small-cell lung cancer (SCLC) combined.2

Telisotuzumab vedotin is an investigational antibody-drug conjugate that targets c-Met, a receptor tyrosine kinase that is overexpressed in tumors, including in NSCLC.

The BTD is supported by findings from the LUMINOSITY study, which is an ongoing phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for telisotuzumab vedotin monotherapy in the second- or third-line settings. Investigators aim to expand the groups to further evaluate efficacy in the selected populations.1

The primary endpoint is overall response rate (ORR) per central review for individuals withing ≥ 12 weeks follow-up. Among individuals with EGFR WT nonsquamous NSCLC, ORR was about 53.8% in the c-Met high group and about 25% in the c-Met intermediate group at a previously reported interim analysis.

Telisotuzumab vedotin is also being evaluated in combination with Osimertinib in the ongoing phase 1 study M14-237 for individuals with previously treated c-Met overexpressing NSCLC.

The drug will be further evaluated as a monotherapy for individuals previously treated with c-Met overexpressing NSCLC in the randomized phase 3 study TeliMET NSCLC-01.

AbbiVie will present telisotuzumab vedotin’s clinical data at upcoming scientific congresses.

Telisotuzumab vedotin is not approved by any regulatory authorities, and its efficacy and safety have not been established yet.

Reference

1. AbbVie announces US FDA granted breakthrough therapy designation (BTD) to telisotuzumab vedotin (Teliso-V) for previously treated non–small cell lung cancer. AbbVie. News release. January 4, 2022. Accessed January 4, 2022. https://news.abbvie.com/news/press-releases/abbvie-announces-us-fda-granted-breakthrough-therapy-designation-btd-to-telisotuzumab-vedotin-teliso-v-for-previously-treated-non-small-cell-lung-cancer.htm

2. National Cancer Institute. Non–small cell lung cancer treatment (PDQ) – health professional version. National Cancer Institute. July 13, 2021. Accessed January 4, 2022. https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_37_toc