June 12, 2017

AbbVie Announces New Data Evaluating Venetoclax in a Variety of Hematologic Malignancies at the 22nd European Hematology Association Congress

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- Results from pivotal VENCLYXTO(venetoclax) trial in relapsed/refractory chronic lymphocytic leukemia (CLL) patients with 17p deletion to be presented

- New data will also include investigational results in acute myeloid leukemia (AML), multiple myeloma (MM) and non-Hodgkin lymphoma (NHL), including a Phase 1 study evaluating the safety and pharmacokinetics of venetoclax in Japanese patients with NHL and MM

NORTH CHICAGO, Illinois, June 12, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that data from multiple clinical trials evaluating venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, will be presented at the 22nd European Hematology Association (EHA) Annual Congress, June 22-25, in Madrid. Investigational data will be presented from 15 studies evaluating venetoclax across some of the most common hematologic malignancies, including chronic lymphocytic leukemia, multiple myeloma, acute myeloid leukemia and non-Hodgkin lymphoma.

VENCLYXTO monotherapy is approved in the EU for the treatment of 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.1 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 investigating the safety and efficacy of venetoclax. The data being presented at EHA reinforce this commitment and underscore our mission to develop and deliver therapies that address unmet needs in a selected set of debilitating hematologic malignancies and have a remarkable impact on the lives of people affected by cancer," said Gary Gordon, M.D., Ph.D., vice president, oncology clinical development, AbbVie.

AbbVie abstracts:

Venetoclax in CLL

  • Venetoclax in relapsed/refractory chronic lymphocytic leukemia (CLL) with 17p deletion: outcome and correlation with minimal residual disease from the full population of the pivotal M13-982 trial; Stilgenbauer et al.; Abstract S771; Oral Presentation; Sunday, June 25, 2017; 8:30-8:45 a.m. CEST
  • Treatment and 17p deletion testing patterns in community practice for patients with chronic lymphocytic leukemia (CLL) in the United States; Kapustyan et al.; Abstract E1023; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
  • Durability of responses on continuous therapy and following drug cessation in deep responders with venetoclax and rituximab; Anderson et al.; Abstract P247; Poster Presentation; Friday, June 23, 2017; 5:15-6:45 p.m. CEST
  • Attainment of complete remission is significantly associated with longer survival outcomes in relapsed/refractory (R/R) CLL: a meta-analysis; Ektare et al.; Abstract E1037; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
  • Impact of venetoclax on the quality of life of CLL patients relapsed/refractory to B-cell receptor (BCR) signaling pathway inhibitor treatment; Wierda et al.; Abstract P728; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST
  • Impact of venetoclax on the quality of life of patients with relapsed/refractory chronic lymphocytic leukemia: results of a Phase 2, open-label study of venetoclax (ABT-199/GDC-0199) monotherapy; Wierda et al.; Abstract E1466; ePOSTER; Friday, June 23, 2017 8:30 a.m. CEST
  • Reduced healthcare resource utilization in patients with chronic lymphocytic leukemia achieving complete remission to first-line therapy; Enschede et al.; Abstract E1035; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
  • Progression-free survival (PFS) and overall survival (OS) in patients with chronic lymphocytic leukemia (CLL) -- clinical benefits of achieving a deep response to first-line therapy; Samp et al.; Abstract PB1791; Publication; Thursday, May 18, 2017; 12:00 p.m. CEST

Venetoclax in AML

  • Safety and efficacy of venetoclax (VEN) in combination with decitabine or azacitidine in treatment-naive, elderly patients (>=65 years) with acute myeloid leukemia (AML); Pratz et al.; Abstract S472; Oral Presentation; Saturday, June 24, 2017; 4:15-4:30 p.m. CEST
  • Updated safety and efficacy results of Phase 1/2 study of venetoclax plus low-dose cytarabine in treatment-naive acute myeloid leukemia patients aged >=65 years and unfit for standard induction therapy; Wei et al.; Abstract S473; Oral Presentation; Saturday, June 24, 2017; 4:30-4:45 p.m. CEST

Venetoclax in NHL/MM

  • A Phase 1 study evaluating the safety and pharmacokinetics of venetoclax in Japanese patients with non-Hodgkin lymphoma and multiple myeloma; Yamamoto et al.; Abstract E1139; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST

Venetoclax in MM

  • A Phase 1b study of venetoclax combined with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma; Moreau et al.; Abstract s460; Oral Presentation; Saturday, June 24, 2017; 5:00-5:15 p.m. CEST
  • BCL2 expression is a potential predictive biomarker of response to venetoclax in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma; Ross et al.; Abstract P682; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST
  • Venetoclax as targeted therapy for relapsed/refractory multiple myeloma; Kumar et al.; Abstract P675; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST

Venetoclax in NHL

  • Venetoclax (VEN) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL); Davids et al.; Abstract P564; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST

The EHA 2017 Annual Congress abstracts are available at www.ehaweb.org.

About VENCLYXTO™ (venetoclax)
VENCLYXTO™ (venetoclax), an oral B-cell lymphoma-2 (BCL-2) inhibitor, is indicated for the treatment of chronic lymphocytic leukaemia (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.1 It is also being evaluated for the treatment of patients with various blood cancer types.1,2,3,4,5 The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.1 VENCLYXTO, which is given once-daily, is designed to selectively inhibit the function of the BCL-2 protein.1

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 Phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with studies in several other cancers.

Venetoclax is currently approved in several countries in Europe, as well as in Argentina, Australia, Mexico, Puerto Rico, Israel, USA, and Canada.  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.

Important Venclyxto (venetoclax) EU Safety Information

Contraindications
Hypersensitivity to the active substance or to any of the excipients is contraindicated. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John's wort as VENCLYXTO efficacy may be reduced.

Special Warnings & Precautions for Use
Tumour lysis syndrome (TLS), including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with VENCLYXTO. VENCLYXTO poses a risk for TLS in the initial 5-week dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLYXTO and at each dose increase. Patients should be assessed for risk and should receive appropriate prophylaxis for TLS.  Blood chemistries should be monitored and abnormalities managed promptly. More intensive measures (including IV hydration, frequent monitoring and hospitalization) should be employed as overall risk increases.

Neutropenia (grade 3 or 4) has been reported and complete blood counts should be monitored throughout the treatment period. 

Live vaccines should not be administered during treatment or thereafter until B-cell recovery.

Drug Interactions
CYP3A inhibitors may increase VENCLYXTO plasma concentrations. At initiation and dose-titration phase: Strong CYP3A inhibitors are contraindicated due to increased risk for TLS and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations. At steady daily dose: If moderate or strong CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations. 

Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.
CYP3A4 inducers may decrease VENCLYXTO plasma concentrations.

Avoid coadministration with strong or moderate CYP3A inducers.  These agents may decrease venetoclax plasma concentrations.

Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.

Adverse Reactions
The most commonly occurring adverse reactions (>=20%) of any grade were neutropenia/neutrophil count decreased, diarrhoea, nausea, anemia, upper respiratory tract infection, fatigue, hyperphosphatemia, vomiting and constipation.

The most frequently occurring adverse reactions (>=2%) were pneumonia, febrile neutropenia and TLS. 

Discontinuations due to adverse reactions occurred in 9.1% of patients and dosage adjustments due to adverse reactions occurred in 11.8% of patients.

Specific Populations 
VENCLYXTO may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during treatment. Advise nursing women to discontinue breastfeeding during treatment.

This is not a complete summary of all safety information. See VENCLYXTO full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Oncology
AbbVie is striving to outsmart cancer by working with scientists, physicians, industry peers, patient advocacy groups and, most importantly, patients to discover, develop and provide new therapies that will have a remarkable impact on the lives of people around the world affected by cancer. Our goal is to provide medicines that make a transformational improvement in cancer treatment and outcomes for cancer patients. By exploring and investing in new pathways, technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers. We are also exploring solutions to help patients obtain access to our cancer medicines. With the acquisition of Pharmacyclics in 2015 and Stemcentrx in 2016, and through several collaborations, AbbVie's oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly 200 clinical trials in 20 different tumor types. For more information about AbbVie Oncology, 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.

AbbVie Forward-Looking Statements
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, 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 2016 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.

References

1 Summary of Product Characteristics for VENCLYXTO.
2 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.
3 Clinicaltrials.gov. NCT01994837: A Phase 2 Study of ABT-199 in subjects with Acute Myelogenous Leukemia (AML). Accessed October 2016.
4 Clinicaltrials.gov. NCT01794520: Study evaluating ABT-199 in subjects with relapsed or refractory Multiple Myeloma. Accessed October 2016.
5 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.

 

Contact(s)


Media
AbbVie Global Media
Dave Freundel
david.freundel@abbvie.com
(224) 358-6576: or AbbVie Europe Media
Carlos Taveras
carlos.taveras@abbvie.com
+ 33 1 41 73 92 64: or
Investors
Liz Shea
liz.shea@abbvie.com
(847) 935-2211