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Subjects: TDS, TRI, FVT

Phase 3 MURANO Study of Venetoclax Chosen as Late-Breaking Abstract at the 2017 American Society of Hematology Annual Meeting & Exposition, Highlighting AbbVie's Commitment to Helping Blood Cancer Patients


NORTH CHICAGO, Ill., Nov. 21, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the American Society of Hematology (ASH) has accepted data from the Phase 3 MURANO study evaluating venetoclax tablets in combination with rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), as an oral, late-breaking presentation during the upcoming 59th ASH Annual Meeting & Exposition, December 9-12, in Atlanta, GA. The abstract is one of six late-breaking abstracts accepted for presentation at the meeting.

In total, 28 AbbVie abstracts have been accepted for ASH 2017. These abstracts include data from investigational studies of the company's portfolio of medicines for investigational or new use in various blood cancers and diseases, including CLL, acute myeloid leukemia (AML), multiple myeloma (MM) and chronic graft-versus-host-disease (cGVHD), among others.

Data will be presented about venetoclax, a B-cell lymphoma-2 (BCL-2) inhibitor, being developed by AbbVie and Genentech, a member of the Roche Group; ibrutinib, an inhibitor of Bruton's tyrosine kinase (BTK) being developed by Pharmacyclics, an AbbVie company, and Janssen Biotech, Inc.; elotuzumab, an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein co-developed by Bristol-Myers Squibb and AbbVie; and other early-stage investigational compounds.

"Our data presentations at this year's ASH Annual Meeting underscore our continued commitment to patients and deep expertise in researching hematologic malignancies across various difficult-to-treat blood cancers," said Gary Gordon, M.D., Ph.D., vice president, oncology clinical development, AbbVie.  "We are especially encouraged by the Phase 3 venetoclax data that ASH accepted for presentation in the late-breaking abstract session. We believe clinical study data for this medicine show the potential of improving treatment across a wide range of blood cancers, including CLL."

Venetoclax clinical data will also be featured in the 2018 "Highlights of ASH" meeting series. These symposia, which are held in the United States, Asia-Pacific and Latin America, feature select hematology research presented at the most recent ASH Annual Meeting in an effort to improve patient management and care strategies.

AbbVie abstracts:

Ibrutinib

Venetoclax

Elotuzumab

ABBV-621

The ASH 2017 Annual Meeting abstracts are available at http://www.hematology.org/Annual-Meeting/Abstracts/.

About IMBRUVICA® (ibrutinib) in the U.S.
IMBRUVICA is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells as well as other serious, debilitating conditions.1,2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.1

IMBRUVICA has been granted four Breakthrough Therapy Designations from the FDA, including in cGVHD. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.3 IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway.

IMBRUVICA is FDA-approved in six distinct patient populations: CLL, small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and cGVHD.1

Accelerated approval was granted for the MCL and MZL indication based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.1

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, 90,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.

Patient Access to IMBRUVICA
AbbVie and Janssen strive to make access to IMBRUVICA easy by helping patients in the U.S. understand their insurance benefits for IMBRUVICA. The YOU&itm Support Program is a program that includes information on access and affordability support options, nurse call support and resources for patients being treated with IMBRUVICA.

IMBRUVICA® (ibrutinib) U.S. IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®.

The mechanism for the bleeding events is not well understood.

IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding.

Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA®. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.

Monitor and evaluate patients for fever and infections and treat appropriately.

Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 13%) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent IMBRUVICA®.
Monitor complete blood counts monthly.

Atrial Fibrillation: Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately, and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines.

Hypertension: Hypertension (range, 6 to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®.
Adjust existing anti-hypertensive medications and/or initiate anti-hypertensive treatment as appropriate.

Second Primary Malignancies: Other malignancies (range, 3 to 16%) including non-skin carcinomas (range, 1 to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 2 to 13%). 

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA® therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions.
Monitor patients closely and treat as appropriate. 

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (?20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (62%), neutropenia (61%), diarrhea (43%), anemia (41%), musculoskeletal pain (30%), rash (30%), bruising (30%), nausea (29%), fatigue (29%), hemorrhage (22%), and pyrexia (21%).

The most common Grade 3 or 4 adverse reactions (?5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (39%), thrombocytopenia (16%), and pneumonia (10%).

Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9% (WM [6%] and MZL [13%]) of patients discontinued due to adverse reactions.

cGVHD: The most common adverse reactions (?20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%), muscle spasms (29%), stomatitis (29%), nausea (26%), hemorrhage (26%), anemia (24%), and pneumonia (21%).

The most common Grade 3 or 4 adverse reactions (?5%) reported in patients with cGVHD were fatigue (12%), diarrhea (10%), neutropenia (10%), pneumonia (10%), sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).

Twenty-four percent of patients receiving IMBRUVICA® in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.

DRUG INTERACTIONS

CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

CYP3A Inhibitors: Dose adjustment may be recommended. 

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA® in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose.

Please see Full Prescribing Information: https://www.imbruvica.com/prescribing-information.

About VENCLEXTAtm (venetoclax) in the U.S.
VENCLEXTA is an oral B-cell lymphoma-2 (BCL-2) inhibitor developed by AbbVie and Genentech, a member of the Roche Group. VENCLEXTA targets a specific protein in the body called BCL-2.4  When you have CLL, BCL-2 may build up and prevent cancer cells from self-destructing naturally. VENCLEXTA targets BCL-2 in order to help restore the process of apoptosis.4 Through apoptosis, your body allows cancer cells and normal cells to self-destruct.

VENCLEXTA has been granted four Breakthrough Therapy Designations from the FDA including for the combination treatment of patients with untreated AML not eligible for standard induction chemotherapy. This designation is intended to expedite the development and review of therapies for serious or life-threatening conditions.3 In January 2016, AbbVie announced that the FDA granted priority review for the single agent NDA application for VENCLEXTA.

In April 2016, U.S. FDA granted accelerated approval of VENCLEXTA for the treatment of patients with relapsed/refractory CLL with 17p deletion, as detected by an FDA-approved test.4 This indication is approved under accelerated approval based on overall response rate.4 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 4

AbbVie and Genentech are committed to BCL-2 research with venetoclax, which is currently being evaluated in combination with other agents in Phase 3 clinical trials for the treatment of relapsed/refractory and first-line CLL,5 along with early phase studies in several cancers.4, 6, 7, 8, 9

Venetoclax is under evaluation by health authorities in multiple countries, and is currently approved in more than 49 nations, including the U.S.

What is VENCLEXTAtm (venetoclax)?
VENCLEXTAtm (venetoclax) is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior treatment.

VENCLEXTA was approved based on response rate. There is an ongoing study to find out how VENCLEXTA works over a longer period of time.

It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information
What is the most important information I should know about VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your doctor will do tests for TLS. It is important to keep your appointments for blood tests. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Tell your doctor right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased.

What should I tell my doctor before taking VENCLEXTA?
Before taking VENCLEXTA, tell your doctor about all of your medical conditions, including if you:

What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:

The most common side effects of VENCLEXTA include low white blood cell count, diarrhea, nausea, low red blood cell count, upper respiratory tract infection, low platelet count, and feeling tired.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your doctor if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. Tell your doctor if you have any side effect that bothers you or that does not go away.

The full U.S. prescribing information for VENCLEXTA can be found here.

Patient Assistance Program
For those who qualify, AbbVie and Genentech offer patient assistance programs for people taking Venclexta in the U.S.

About EMPLICITItm (elotuzumab) in the U.S.
EMPLICITI is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.10

EMPLICITI has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. EMPLICITI also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.

On November 30, 2015, the U.S. Food and Drug Administration (FDA) approved EMPLICITI in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received one to three prior therapies. The safety and efficacy of EMPLICITI is still being evaluated by other health authorities. Bristol-Myers Squibb and AbbVie are co-developing EMPLICITI, with Bristol-Myers Squibb solely responsible for commercial activities.

EMPLICITItm (elotuzumab) U.S. IMPORTANT SAFETY INFORMATION

WHAT IS EMPLICITI?

EMPLICITItm (elotuzumab) is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in people who have received one to three prior treatments for their multiple myeloma.

It is not known if EMPLICITI is safe and effective in children.

IMPORTANT SAFETY INFORMATION

EMPLICITI is used in combination with REVLIMID and dexamethasone. It is important to remember that the safety information for these medications also applies to EMPLICITI combination therapy.

Before you receive EMPLICITI, tell your healthcare provider about all of your medical conditions, including if you: 

Serious side effects that can occur with EMPLICITI treatment are:

Infusion reactions

Infections

Risk of new cancers (malignancies)

Liver problems

The most common side effects of EMPLICITI include:

These are not all of the possible side effects of EMPLICITI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read Patient Information in the full Prescribing Information.

About ABBV-621
ABBV-621 is a first-in-class, second-generation TRAIL-receptor agonist under development for the treatment of solid and hematologic tumors.

About Pharmacyclics, An AbbVie Company
Pharmacyclics LLC, a wholly-owned subsidiary of AbbVie (NYSE: ABBV), is focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune-mediated diseases. Pharmacyclics' mission is to develop and commercialize novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs.

Pharmacyclics markets IMBRUVICA and has two product candidates in clinical development and several preclinical molecules in lead optimization. Pharmacyclics is committed to high standards of ethics, scientific rigor and operational efficiency as it moves each of these programs toward commercialization. To learn more, please visit www.pharmacyclics.com.

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.

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 IMBRUVICA US Prescribing Information, January 2017.
2 Genetics Home Reference (2017). Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed November 2017.
3 U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies. Available from: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed November 2017
4 VENCLEXTA [Package Insert]. North Chicago, Ill.: AbbVie Inc.
5 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 November 2017.
6 Clinicaltrials.gov. NCT01994837: A Phase 2 Study of ABT-199 in subjects with Acute Myelogenous Leukemia (AML). Accessed November 2017.
7 Clinicaltrials.gov. NCT01794520: Study evaluating ABT-199 in subjects with relapsed or refractory Multiple Myeloma. Accessed November 2017.
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 November 2017.
9 Clinicaltrials.gov. NCT01889186: A study of the efficacy of ABT-199 in subjects with relapsed/refractory or previously untreated chronic lymphocytic leukemia with the 17p deletion. Accessed November 2017.
10 Empliciti [Package Insert]. Princeton, N.J.: Bristol-Myers Squibb Company.

 

SOURCE AbbVie


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