AbbVie Announces U.S. FDA Granted Breakthrough Therapy Designation (BTD) to Telisotuzumab Vedotin (Teliso-V) for Previously Treated Non-Small Cell Lung Cancer

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.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law

¹ U.S. Food and Drug Administration. Breakthrough Therapy. https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies. Accessed December 17, 2021. 
² Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313. PMID: 30207593.
³ National Cancer Institute. Non-small cell lung cancer treatment – health professional version. https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_37_toc. Accessed December 8, 2021.

SOURCE AbbVie