- ABBVIE PLANS TO SUBMIT REGULATORY APPLICATIONS FOR VENETOCLAX TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND THE EUROPEAN MEDICINES AGENCY (EMA) BEFORE THE END OF 2015
Aug 12, 2015
NORTH CHICAGO, Ill., Aug. 12, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that a Phase 2 trial of its investigational medicine venetoclax met its primary endpoint of achieving overall response rates in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion, according to an independent review analysis. The open-label study evaluated the efficacy and safety of venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche.
Data from this study will be presented at an upcoming medical conference and will serve as the pivotal registration data for applications to the FDA, EMA and other health authorities. The safety profile was similar to previous studies and no unexpected safety signals were reported for venetoclax.
"The results from this study demonstrate the clinical activity of venetoclax in patients with relapsed/refractory CLL who have 17p deletion, a patient population that has historically been difficult to treat," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "Based on these results, we intend to advance regulatory submissions for venetoclax and remain committed to the further development of this investigational medicine, and others in our pipeline, with the goal of delivering new treatment options for people affected by cancer."
In 2015, the FDA granted Breakthrough Therapy Designation to venetoclax for the evaluation of treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.
About Chronic Lymphocytic Leukemia (CLL) and 17p Deletion
CLL is a slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, a type of white blood cell.1 It is the most common leukemia diagnosed in adults in western countries.2 In the United States, CLL accounts for approximately 14,620 new cases of leukemia diagnosed each year.3
Approximately 3-10 percent of CLL patients have 17p deletion at diagnosis, and it occurs in 30-50 percent of patients with relapsed/refractory CLL.4 The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent.5The median life expectancy for CLL patients with 17p deletion is less than 2-3 years.6
About the Phase 2 Study
The Phase 2, multicenter, international, open label clinical trial was designed to evaluate the efficacy and safety of venetoclax in CLL patients with 17p deletion who relapsed, were refractory to existing therapies, or who were previously not treated for their CLL. The study has enrolled 157 patients, 107 in the main study cohort evaluating efficacy, and 50 patients in the safety expansion cohort.
The primary efficacy endpoint is overall response rate and the primary safety endpoints are the number and percentage of patients who experienced treatment-related adverse events, changes in physical exam findings, including vital signs, changes in clinical laboratory test results and changes in cardiac assessment findings. Secondary efficacy outcome measures include complete remission rate, partial remission rate, duration of response, overall survival and progression-free survival, among others.
Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated for the treatment of patients with various cancer types. The BCL-2 protein prevents apoptosis of some cells, including lymphocytes, and can be expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein. Venetoclax is being developed in collaboration with Genentech and Roche. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with studies in several other cancers. Venetoclax is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.
About AbbVie Oncology
AbbVie's oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers, including glioblastoma multiforme, multiple myeloma and chronic lymphocytic leukemia. AbbVie's oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types. For more information on AbbVie Oncology, please visithttp://oncology.abbvie.com.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedInpage.
Some statements in this news release may be 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, the likelihood that the transaction is consummated, the expected benefits of the transaction, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. 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 American Cancer Society (2013) "Leukemia – Chronic Lymphocytic."http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf.
2 Eichhorst, B. et al. "Chronic Lymphocytic Leukemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up." Annals of Oncology 22 (Supplement 6): vi50-vi54, 2011
3 American Cancer Society (2015) "Leukemia – Chronic Lymphocytic (CLL) Topics."
4 Schnaiter, A. et al. (2013) "17p Deletion in Chronic Lymphocytic Leukemia: Risk Stratification and Therapeutic Approach." Hematol Oncol Clin N Am 27 (2013) 289–301
5 Selner, L. et al. (2013) "What Do We Do with Chronic Lymphocytic Leukemia with 17p Deletion?" Curr Hemetol Malig Rep. 8(1):81-90.
6 Stilgenbaur, S, and Zenz, T, (2010) "Understanding and Managing Ultra High-Risk Chronic Lymphocytic Leukemia." ASH Education Book. 2010(1):481-488.