May 15, 2020

AbbVie Data at EHA Annual Congress Highlight Depth and Breadth of Transformative Blood Cancer Portfolio

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- AbbVie to present more than 30 abstracts from studies of its on-market and investigational medicines from its oncology portfolio and pipeline across six tumor types at the EHA Annual Congress
- Presentations of data from the CLL14 trial evaluating venetoclax in combination with obinutuzumab in patients with previously-untreated CLL (abstract #S155)
- Extended follow-up from subgroup-analyses of MURANO trial of venetoclax in combination with rituximab in relapsed/refractory CLL (abstract #EP694)
- New data from several investigational studies of venetoclax combinations in patients with AML

NORTH CHICAGO, Ill., May 15, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from studies evaluating the BCL-2 inhibitor venetoclax (VENCLEXTA®/ VENCLYXTO®), among others, from clinical trials across multiple blood cancers at the 25th European Hematology Association (EHA) Annual Congress, being held virtually from June 11-14, 2020. These data will span the company's investigational and approved oncology portfolio medicines across chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), multiple myeloma (MM), myelodysplastic syndrome (MDS) and myelofibrosis (MF).

"We continue to demonstrate the broad utility of our oncology portfolio – anchored by VENCLEXTA/VENCLYXTO and IMBRUVICA – with new, longer-term and clinically meaningful results presented at this year's EHA meeting," said Neil Gallagher, M.D., Ph.D., chief medical officer and vice president of development, AbbVie. "We are excited to share these studies with the global oncology community as they reflect our ongoing commitment to improving care for patients with various difficult-to-treat blood cancers."

Researchers will present during EHA data based on findings from the Phase 3 CLL14 trial evaluating venetoclax in combination with obinutuzumab in patients with previously-untreated CLL (abstract #S155). In March 2020, AbbVie announced the approval of venetoclax plus obinutuzumab in the European Union, based on data from the CLL14 trial.1 Additionally, several abstracts from studies of venetoclax in  various tumor types will be presented, including:

  • Extended follow-up data from the Phase 3 MURANO trial on subgroup-analyses of venetoclax in combination with rituximab in relapsed/refractory CLL, including the impact of premature discontinuation/interruption of venetoclax on outcomes in these patients (abstracts #EP694 and #EP691)
  • New data on safety and efficacy will be featured from the CAPTIVATE study evaluating ibrutinib (IMBRUVICA®) plus venetoclax in first-line treatment of CLL (abstract #S158)
  • Six-month update from the Phase 3 VIALE-C study of venetoclax in combination with low-dose cytarabine in previously untreated older patients with AML (abstract #S136)

AbbVie sponsored abstracts accepted by EHA include:

Abstract

Session+

Ibrutinib

First-Line Ibrutinib (Ibr) + Venetoclax (VEN) For Patients (Pts) With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Efficacy And Safety Results From CAPTIVATE-MRD Study. Siddiqi et al. Abstract #S158

Oral Session: CLL – Targeted Therapy I

Ibrutinib Treatment For Pediatric Chronic Graft Versus Host Disease: A Prospective Phase 1/2 Study. Zecca et al. Abstract #EP1387

E-Poster Session: Stem Cell Transplantation - Clinical

Prognostic Biomarker Testing And Treatment Selections In Patients With Chronic Lymphocytic Leukemia Pre- And Post-Approval Of Novel Agents. Mato et al. Abstract #EP712

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders - Clinical

Application Of iwCLL Guidelines For Response Assessment In The Treatment Of Patients With Chronic Lymphocytic Leukemia In The Real-World: An Analysis From The INFORMCLL™ Registry. Barrientos et al. Abstract #PB1908

Publication Only Abstract

Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Venetoclax in CLL

Extrapolating Progression Free Survival Curves In CLL Using Peripheral Blood MRD Measurements From Venetoclax Trials. Alexiou et al.; Abstract #EP708

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Efficacy of Venetoclax in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Primary Endpoint Analysis of the International Phase 3b Trial (VENICE I). Kater et al.; Abstract #S156

Oral Session: CLL – Targeted Therapy I

Impact of Venetoclax Monotherapy on The Quality of Life of Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia: Results from VENICE II Phase 3b Trial. Cochrane et al.; Abstract #EP701

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Phase 3b Study to Evaluate Debulking Regimens Prior to Initiating Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia. Sharman et al.; Abstract #EP687

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Neutropenia Analysis of Venetoclax Monotherapy in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia: Pooled Data from VENICE-I and -II Phase 3b Trials. Anderson et al.; Abstract #EP718

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Fixed-Duration Venetoclax-Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia: Follow-Up of Efficacy and Safety Results from the Multicenter, Open-Label, Randomized, Phase 3 CLL14 Trial. Al-Sawaf et al.; Abstract #S155

Oral Session: CLL – Targeted Therapy I

Characteristics and Outcome of Patients with Chronic Lymphocytic Leukaemia and Partial Response to Venetoclax-Obinutuzumab. Al-Sawaf et al.; Abstract #EP699

E-Poster Session: Chronic Lymphocytic Leukemia and Related Disorders – Clinical

Impact of Premature Venetoclax (VEN) Discontinuation/Interruption on Outcomes in Relapsed/ Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 MURANO Study. Mato et al.; Abstract #EP691

E-Poster Session: Chronic Lymphocytic Leukemia And Related Disorders – Clinical

Extended Follow-Up in BIRC3- Mutated Relapsed/Refractory Chronic Lymphocytic Leukemia (R/R CLL) Patients Treated With Fixed-Duration Venetoclax Plus Rituximab: Subgroup Analyses of the MURANO Trial. Kater et al.; Abstract #EP694

E-Poster Session: Chronic Lymphocytic Leukemia And Related Disorders – Clinical

Systematic Literature Review and Network Meta-Analysis Comparing Therapies for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia. Sail et al.; Abstract #EP725

E-Poster Session: Chronic Lymphocytic Leukemia And Related Disorders – Clinical

CLL2-GiVe, a Prospective, Open-Label, Multicenter Phase-2 Trial of Obinutuzumab (Ga101, G), Ibrutinib (I), Plus Venetoclax (Ve) in Untreated Patients with CLL With 17p Deletion / Tp53 Mutation. Huber et al.; Abstract #S157

Oral Session: CLL – Targeted Therapy I

Kinetics of Response in the Peripheral Blood Predicts Long Term Responses to Ibrutinib + Venetoclax Treatment for Relapsed/Refractory CLL in the Bloodwise TAP CLARITY trial. Rawstron et al.; Abstract #S164

Oral Session: CLL – Targeted Therapy II

Venetoclax in AML

Long-Term Follow Up: Phase 1b/2 Study of Venetoclax Plus Low-Dose Cytarabine in Previously Untreated Older Adults with Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy. Wei et al.; Abstract #EP554

E-Poster Session: Acute Myeloid Leukemia – Clinical

Timing of Response to Venetoclax Combination Treatment in Older Patients with Acute Myeloid Leukemia. Jonas et al.; Abstract #EP535

E-Poster Session: Acute Myeloid Leukemia – Clinical

Real-World Data (RWD) Cohort of Patients with Acute Myeloid Leukemia (AML) in the United States from an Electronic Health Record (EHR)–Derived De-Identified Database. Flahavan et al.; Abstract #EP600

E-Poster Session: Acute Myeloid Leukemia – Clinical

Transfusion Burden on Older Patients with Acute Myeloid Leukemia Receiving Low-Intensity Treatments. Le Blanc et al.; Abstract #EP1739

E-Poster Session: Quality of Life, Palliative & Supportive Care, Ethics and Health Economics

Phase 1b/2 Study of the IDH1-Mutant Inhibitor Ivosidenib with the BCL2 Inhibitor Venetoclax +/- Azacitidine in IDH1-Mutated Hematologic Malignancies. DiNardo et al.; Abstract #S143*

Oral Session: Acute Myeloid Leukemia – Clinical

A Phase 3 Study of Venetoclax Plus Low-Dose Cytarabine in Previously Untreated Older Patients with Acute Myeloid Leukemia (VIALE-C): A 6-Month Update. Wei et al.; Abstract #S136

Oral Session: AML Randomized Trials

Treatment Patterns and Outcomes of Newly Diagnosed Acute Myeloid Leukemia Patients Receiving Venetoclax Combinations Vs Other Therapies: Results from the AML Real World Evidence (ARC) Initiative. Talati et al. Abstract #PB1831

Publication Only Abstract

Acute Myeloid Leukemia – Clinical

First-In-Human Study of a TRAIL Receptor Agonist Fusion Protein, Eftozanermin Alfa, in Patients With Relapsed/Refractory Acute Myeloid Leukemia and Diffuse Large B-Cell Lymphoma. Jongen-Lavrencic et al. Abstract #EP589

E-Poster Session: Acute Myeloid Leukemia – Clinical

Venetoclax in MDS

A Phase 1b Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine for the Treatment of Relapsed/Refractory Myelodysplastic Syndrome. Zeidan et al.; Abstract #S188

Oral Session: Myelodysplastic Syndromes – Clinical

The Prognostic Impact of Cytogenetic Scores in Patients with Higher-Risk Myelodysplastic Syndrome Treated with Venetoclax and Azacitidine in a Phase 1 Study. Garcia et al.; Abstract #EP795

E-Poster Session: Myelodysplastic Syndromes – Clinical

Venetoclax in ALL

Safety and Efficacy of Venetoclax in Combination with Navitoclax in Adult and Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Jabbour et al.; Abstract #S116

Oral Session: Cellular, Antibody and Targeted Therapy

Venetoclax in MM

Updated Results from a Phase 1/2 Study of Venetoclax in Combination with Daratumumab and Dexamethasone, +/- Bortezomib, in Patients with Relapsed/Refractory Multiple Myeloma. Kaufman et al.; Abstract #EP940

E-Poster Session: Myeloma and Other Monoclonal Gammopathies – Clinical

Updated Results from BELLINI, a Phase 3 Study of Venetoclax or Placebo  in Combination With Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma. Kumar et al.; Abstract #EP939

E-Poster Session: Myeloma and Other Monoclonal Gammopathies – Clinical

Evaluation of Minimal Residual Disease in Relapsed/Refractory Multiple Myeloma Patients Treated with Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone: BELLINI Study Analyses. Moreau et al.; Abstract #EP975

E-Poster Session: Myeloma and Other Monoclonal Gammopathies – Clinical




The EHA 2020 Annual Congress abstracts are available at www.ehaweb.org.

AbbVie will also present data from 17 accepted abstracts during the virtual American Society of Clinical Oncology (ASCO) Annual Meeting from May 29-31, 2020, including studies of ibrutinib, venetoclax and veliparib. 

About IMBRUVICA
IMBRUVICA is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company and Janssen Biotech, Inc. The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.2,3 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.4

Since its launch in 2013, IMBRUVICA has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström's macroglobulinemia (WM); previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.5

IMBRUVICA is now approved in 99 countries and has been used to treat more than 195,000 patients worldwide across its approved indications. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

In early 2019, the National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and it is the only Category 1 treatment for treatment-naïve patients without deletion 17p. In February 2020, the NCCN Guidelines® were updated to elevate IMBRUVICA with or without rituximab from other recommended regimens to a preferred regimen for the treatment of relapsed/refractory MCL.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 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. For more information, visit www.IMBRUVICA.com.

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

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients who received IMBRUVICA®. Major hemorrhage (≥ Grade 3, serious, or any central nervous system events; e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) occurred in 4% of patients, with fatalities occurring in 0.4% of 2,838 patients who received IMBRUVICA® in 27 clinical trials. Bleeding events, including bruising and petechiae, occurred in 39% of patients who received IMBRUVICA®.

The mechanism for the bleeding events is not well understood.

Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA® increases the risk of major hemorrhage. Across clinical trials, 3.1% of 2,838 patients who received IMBRUVICA® without antiplatelet or anticoagulant therapy experienced major hemorrhage.  The addition of antiplatelet therapy with or without anticoagulant therapy increased this percentage to 4.4%, and the addition of anticoagulant therapy with or without antiplatelet therapy increased this percentage to 6.1%.  Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA®. Monitor for signs and symptoms 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 21% of 1,476 patients who received IMBRUVICA® in clinical trials. 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: In 645 patients with B?cell malignancies who received IMBRUVICA® as a single agent, Grade 3 or 4 neutropenia occurred in 23% of patients, Grade 3 or 4 thrombocytopenia in 8% and Grade 3 or 4 anemia in 3%, based on laboratory measurements.

Monitor complete blood counts monthly.

Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA®. Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of patients and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 4% of 1,476 patients who received IMBRUVICA® in clinical trials. These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias.

Periodically monitor patients clinically for cardiac arrhythmias. Obtain an ECG for patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness, syncope, chest pain) or new onset dyspnea. Manage cardiac arrhythmias appropriately, and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines.

Hypertension: Hypertension occurred in 19% of 1,476 patients who received IMBRUVICA® in clinical trials.  Grade 3 or greater hypertension occurred in 8% of patients. Based on data from 1,124 of these patients, the median time to onset was 5.9 months (range, 0.03 to 24 months).  

Monitor blood pressure in patients treated with IMBRUVICA® and initiate or adjust anti-hypertensive medication throughout treatment with IMBRUVICA® as appropriate.

Second Primary Malignancies: Other malignancies (10%), including non-skin carcinomas (4%), occurred among the 1,476 patients who received IMBRUVICA® in clinical trials. The most frequent second primary malignancy was non-melanoma skin cancer (6%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA®. 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 pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA® and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥30%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (54.5%)*, diarrhea (43.8%), fatigue (39.1%), musculoskeletal pain (38.8%), neutropenia (38.6%)*, rash (35.8%), anemia (35.0%)*, and bruising (32.0%).

The most common Grade ≥ 3 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (20.7%)*, thrombocytopenia (13.6%)*, pneumonia (8.2%), and hypertension (8.0%).

Approximately 9% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] 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 higher adverse reactions (≥5%) reported in patients with cGVHD were pneumonia (14%), fatigue (12%), diarrhea (10%), neutropenia (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.

*Treatment-emergent decreases (all grades) were based on laboratory measurements.

DRUG INTERACTIONS

CYP3A Inhibitors: Co-administration of IMBRUVICA® with strong or moderate CYP3A inhibitors may increase ibrutinib plasma concentrations.  Dose modifications of IMBRUVICA® may be recommended when used concomitantly with posaconazole, voriconazole, and moderate CYP3A inhibitors. Avoid concomitant use of other strong CYP3A inhibitors.  Interrupt IMBRUVICA® if strong inhibitors are used short-term (e.g., for ≤ 7 days).  See dose modification guidelines in USPI sections 2.4 and 7.1.

CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA® in patients with severe baseline hepatic impairment. In patients with mild or moderate impairment, reduce recommended IMBRUVICA® dose and monitor more frequently for adverse reactions of IMBRUVICA®.

Please click here for full Prescribing Information.

About VENCLEXTA®/VENCLYXTO® (venetoclax) 

VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

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 and to studying venetoclax in clinical trials across several blood and other cancers. 

VENCLEXTA/VENCLYXTO is approved in more than 50 countries, including the U.S. AbbVie, in collaboration with Roche, is currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

Uses and Important VENCLEXTA® (venetoclax) U.S. Safety Information6

Uses
VENCLEXTA is a prescription medicine used:

  • to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
    • are 75 years of age or older, or
    • have other medical conditions that prevent the use of standard chemotherapy.

      This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

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 healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. 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. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider 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 during treatment with 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.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects.

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 because of the risk of increased TLS.

  • Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
  • Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.

Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney or liver problems.
  • have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
  • have a history of high uric acid levels in your blood or gout.
  • are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
  • are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
  • are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA.

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:

  • Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA.
  • Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.

Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include low white blood cell counts; nausea; diarrhea; low platelet counts; constipation; fever with low white blood cell counts; low red blood cell counts; infection in blood; rash; dizziness; low blood pressure; fever; swelling of your arms, legs, hands, and feet; vomiting; tiredness; shortness of breath; bleeding; infection in lung; stomach (abdominal) pain; pain in muscles or back; cough; and sore throat.

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

These are not all the possible side effects of VENCLEXTA. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact www.medicineassistancetool.org for assistance.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. 

Indication and Important VENCLYXTO (venetoclax) EU Safety Information7

Indication

Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

Venclyxto monotherapy is indicated 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, or
  • In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

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 tumor lysis syndrome (TLS). Concomitant use of preparations containing St. John's wort as VENCLYXTO efficacy may be reduced.

Special Warnings & Precautions for Use

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, monitoring, and management for TLS.

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

Serious infections including sepsis with fatal outcome have been reported. Monitoring of any signs and symptoms of infection is required.  Suspected infections should receive prompt treatment including antimicrobials and dose interruption or reduction as appropriate.  

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:  moderate or strong CYP3A inhibitors must be used, physicians should refer to the VENCLYXTO summary of product characteristics (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 in patients receiving venetoclax in the combination studies with obinutuzumab or rituximab were neutropenia, diarrhoea, and upper respiratory tract infection.  In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.

The most frequently occurring serious adverse reactions (>=2%) in patients receiving venetoclax in combination with obinutuzumab or rituximab were pneumonia, sepsis, febrile neutropenia, and TLS.  In the monotherapy studies, the most frequently reported serious adverse reactions (>=2%) were pneumonia and febrile neutropenia.

Discontinuations due to adverse reactions occurred in 16% of patients treated with venetoclax in combination with obinutuzumab or rituximab in the CLL14 and Murano studies respectively.  In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions. 

Dosage reductions due to adverse reactions occurred in 21% of patients treated with the combination of venetoclax and obinutuzumab in CLL14 and in 15% of patients treated with the combination of venetoclax and in Murano and in 14% of patients treated with venetoclax in the monotherapy studies.    The most common adverse reaction that led to dose interruptions was neutropenia. 

Specific Populations

Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS.  Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined.

For patients with severe (Child-Pugh C) hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended.

VENCLYXTO may cause embryo-fetal harm when administered to a pregnant woman. 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 https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf. Globally, prescribing information varies; refer to the individual country product label for complete information.

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. AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types. For more information, please visit http://www.abbvie.com/oncology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebook, InstagramYouTube and LinkedIn.

Forward-Looking Statements
Some statements in this news release are, or may be considered, 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, competition from other products, challenges to intellectual property, 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," of AbbVie's 2019 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 AbbVie Receives European Commission Approval of VENCLYXTO® Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia. Published online March 12, 2020. https://news.abbvie.com/news/press-releases/abbvie-receives-european-commission-approval-venclyxto-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia.htm.
2 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed January 2020.
3 Turetsky, et al. Single cell imaging of Bruton's Tyrosine Kinase using an irreversible inhibitor. Scientific Reports. volume 4, Article number: 4782 (2014).
4  de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594.
5 IMBRUVICA U.S. Prescribing Information, April 2020.
6 VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL.: AbbVie Inc. 
7 Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.

+ Presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

* Venetoclax is indicated in AML and CLL

 

SOURCE AbbVie

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