— Results of a multicenter, open-label, randomized Phase 3 study of VENCLEXTA™/VENCLYXTO™ (Venetoclax) Tablets in combination with Rituxan® met the primary endpoint of prolonged progression-free survival compared with bendamustine in combination with Rituxan in patients with relapsed/refractory CLL
— Results will be the basis for regulatory submissions; full data will be presented at an upcoming medical conference
— Treatment regimen previously granted Breakthrough Therapy Designation (BTD) in U.S.
NORTH CHICAGO, IL, USA I September 18, 2017 I AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Phase 3 MURANO study of VENCLEXTA™/VENCLYXTO™ (Venetoclax) Tablets in combination with Rituxan® (rituximab) met its primary endpoint. Results showed that VENCLEXTA/VENCLYXTO in combination with Rituxan prolonged progression-free survival (PFS) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) compared with bendamustine combined with Rituxan. An independent data monitoring committee reviewed this study and made the recommendation to unblind the trial based on the positive results. Doctors will continue to monitor patients who remain active in the MURANO trial in efforts to obtain additional, longer-term safety and efficacy information. VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
“AbbVie is committed to researching the full potential of VENCLEXTA/VENCLYXTO both as monotherapy and combination therapy in patients with CLL and other hematologic malignancies. The analysis of the MURANO trial showed that VENCLEXTA/VENCLYXTO in combination with Rituxan may offer another option for patients with R/R CLL, potentially providing them with a chemotherapy-free therapy,” said Michael Severino, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. “We are looking forward to working with regulatory authorities around the world to bring this additional treatment regimen to R/R CLL patients.”
The most common type of leukemia in the Western world is CLL, which accounts for approximately one-quarter of new cases of leukemia in the U.S.1,2 CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (type of white blood cells) are found predominantly in the blood and bone marrow.3 CLL usually affects older patients, with more men than women affected. The median age at diagnosis is approximately 70 years.1
Full data from this study will support regulatory submissions for VENCLEXTA/VENCLYXTO in combination with Rituxan therapy in R/R CLL, and will be presented at an upcoming medical conference. Safety data, including serious and most common adverse events and discontinuation rates, are currently being analyzed.
About the Phase 3 Study
The multicenter, open-label, randomized Phase 3 MURANO study was designed to evaluate the efficacy and safety of VENCLEXTA/VENCLYXTO in combination with Rituxan compared with bendamustine in combination with Rituxan in patients with R/R CLL.4 The primary endpoint was investigator-assessed progression-free survival (PFS), which was determined using standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Secondary endpoints included Independent Review Committee (IRC)-assessed PFS, as well as PFS in patients with 17p deletion, best overall response (defined as complete response [CR], complete response with incomplete marrow recovery [CRi], nodular partial remission [nPR], or PR), overall survival, event-free survival, duration of response, time to next anti-CLL treatment, and percentage of patients achieving minimal residual disease negativity.
About VENCLEXTA™/VENCLYXTO™
VENCLEXTA/VENCLYXTO is an oral B-cell lymphoma-2 (BCL-2) inhibitor that targets a specific protein in the body called BCL-2. When you have CLL, BCL-2 may build up and prevent cancer cells from self-destructing naturally. VENCLEXTA/VENCLYXTO targets BCL-2 in order to help restore the process of apoptosis. Through apoptosis, your body allows cancer cells and normal cells to self-destruct.
VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in clinical trials in several hematologic cancers.
VENCLEXTA/VENCLYXTO is under evaluation by health authorities in multiple countries, and is currently approved in 16 nations, including the U.S., and in the EU. AbbVie, in collaboration with Roche and Genentech, is currently working with regulatory agencies around the world to bring this medicine to eligible patients in need.
About VENCLYXTO™ (venetoclax) Tablets (EU)
VENCLYXTO™ (venetoclax) is indicated in the European Union (EU) for the treatment of chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.5 It is also being evaluated for the treatment of patients with various blood cancer types.5,6,7,8,9 The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.5 VENCLYXTO, which is given once-daily, is designed to selectively inhibit the function of the BCL-2 protein.5
About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumor types. For more information, please visit http://abbvieoncology.com.
About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
References
1 Eichhorst B, et al. Chronic lymphocytic leukaemia ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology; 2015;26;v78–v84.
2 American Cancer Society. What are the key statistics for chronic lymphocytic leukemia? https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/key-statistics.html. Accessed August 22, 2017.
3 NCI dictionary. NCI Dictionary of Terms. Chronic Lymphocytic Leukemia. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed August 22, 2017.
4 Clinicaltrials.gov. NCT02005471: A Study of Venetoclax in Combination With Rituximab Compared With Bendamustine in Combination With Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia. Accessed August 2017.
5 Venclyxto (venetoclax) Summary of Product Characteristics. December 2016.
6 Clinicaltrials.gov. NCT01994837: A Phase 2 Study of ABT-199 in subjects with Acute Myelogenous Leukemia (AML). Accessed October 2016.
7 Clinicaltrials.gov. NCT01794520: Study evaluating ABT-199 in subjects with relapsed or refractory Multiple Myeloma. Accessed October 2016.
8 Clinicaltrials.gov. NCT01328626: A Phase 1 study evaluating the safety and pharmacokinetics of ABT-199 in subjects with relapsed or refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma. Accessed October 2016.
9 Clinicaltrials.gov. NCT01889186: A study of the efficacy of ABT-199 in subjects with relapsed or refractory chronic lymphocytic leukemia with the 17p deletion. Accessed October 2016.
10 Venclexta (venetoclax) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
SOURCE: AbbVie
