NORTH CHICAGO, Ill., May 31, 2015 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global biopharmaceutical company, today announced that results from a Phase 1b trial of investigational venetoclax, a novel inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, in combination with bortezomib and dexamethasone, showed an 83 percent overall response rate (n=5/6) in bortezomib-naive patients with relapsed/refractory (R/R) multiple myeloma, including two patients who achieved complete responses.1 These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31, in Chicago.
AbbVie will also present during ASCO a separate Phase 1 monotherapy study in heavily pre-treated patients with R/R multiple myeloma, which showed an overall response rate of 29 percent (n=2/7) in patients with t(11;14) chromosomal abnormality.2
Multiple myeloma is the second most common blood cancer and begins in plasma cells in the bone marrow.3 When plasma cells in the marrow become cancerous, they can grow uncontrollably and form tumors, typically developing in the bone. When a patient has multiple plasma cell tumors, they have multiple myeloma.
"Multiple myeloma remains a high area of unmet medical need and additional research to identify new therapies is important," said Cyrille Touzeau, M.D., Department of Hematology, University of Nantes, France. "The response rates shown in these studies suggest potential of venetoclax in this patient population and warrant further evaluation."
"We are extremely encouraged by these results and will continue evaluating this compound in a variety of tumor types, including additional studies in patients with multiple myeloma," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie.
Investigation of venetoclax in several additional blood cancers is currently ongoing.
About the Combination Study – Abstract #8580
The Phase 1b multicenter, international clinical trial was designed to determine the safety, pharmacokinetics, preliminary efficacy and maximum tolerated dose of venetoclax in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma. The 32 patients enrolled in the study were segmented by their sensitivity to bortezomib. The median time on study for both the bortezomib-sensitive and bortezomib-naive patients was five months, compared to 1.3 months for bortezomib-refractory patients.
In the study, venetoclax used in combination with bortezomib and dexamethasone showed an 83 percent overall response rate (ORR) (n=5/6) in bortezomib-naive patients—including two complete responses—and a 63 percent ORR (n=10/16) in bortezomib-sensitive patients. An overall response rate was not seen in patients who were bortezomib-refractory. A complete response (CR) is sometimes called complete remission.
The most common adverse events in this study (≥ 20% of patients) included constipation (41%), diarrhea (38%), peripheral edema (28%), thrombocytopenia (31%), peripheral neuropathy (28%), insomnia (28%), dyspnea (25%) and anemia (22%). Grade 3 and 4 adverse events (≥ 10% of patients) included thrombocytopenia (25%) and anemia (13%).
About the Monotherapy Study – Abstract #8576
The Phase 1 multicenter, international clinical trial was designed to determine the safety, pharmacokinetics, preliminary efficacy and maximum tolerated dose of venetoclax as a monotherapy in patients with R/R multiple myeloma. Of the 28 patients enrolled in the study, 10 were t(11;14)-positive, the most common chromosomal abnormality in patients with multiple myeloma.4 The ORR in t(11;14)-positive patients evaluable for assessment was 29 percent (n=2/7), including one CR and one partial response. Additionally, t(11;14)-positive patients had a median time on study of 5.1 months compared to 1.9 months for t(11;14)-negative patients.
Common adverse events in this study (≥ 20% of patients) included diarrhea (32%), nausea (32%), neutropenia (21%) and fatigue (21%). Grade 3 and 4 adverse events (≥ 10% of patients) included thrombocytopenia (18%), anemia (14%) and neutropenia (14%).
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 first-line and relapsed/refractory CLL, along with studies in several other cancers. In 2015, the FDA granted Breakthrough Therapy Designation to venetoclax for the treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. 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, we are 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 and AbbVie's oncology portfolio, please visit http://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 LinkedIn page.
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 Touzeau, C. et al. Abstract 8580. Phase 1b Interim Results: Venetoclax (ABT-199/GDC-0199) in Combination with Bortezomib (BTZ) and Dexamethasone (Dex) in Relapsed/Refractory (R/R) Multiple Myeloma (MM). Accepted for presentation at the 51st American Society of Clinical Oncology Annual Meeting; May 29-June 2, 2015, Chicago.
2 Kumar, S. et al. Phase I Interim Safety and Efficacy of Venetoclax (ABT-199/GDC-0199) Monotherapy for Relapsed/Refractory (R/R) Multiple Myeloma (MM). Accepted for presentation at the 51st American Society of Clinical Oncology Annual Meeting; May 29-June 2, 2015, Chicago.
3 The Multiple Myeloma Research Foundation website. "About Multiple Myeloma" http://www.themmrf.org/multiple-myeloma/. Accessed April, 2015
4 An, G. et al. (2013) "t(11;14) multiple myeloma: a subtype associated with distinct immunological features, immunophenotypic characteristics but divergent outcome." Leuk Res. 37(10):1251-7
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