May 30, 2019

AbbVie Presents Results from Several Studies and Clinical Trials Investigating Medicines Across More than 15 Cancers at the 2019 ASCO and EHA Meetings

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- AbbVie to present more than 40 abstracts from its oncology pipeline at this year's ASCO and EHA medical meetings in June
- Results from the Phase 3 CLL14 trial of venetoclax plus obinutuzumab in previously untreated chronic lymphocytic leukemia (CLL) to be presented as an oral at ASCO
- New ibrutinib (IMBRUVICA®) six-year and five-year data evaluating its long-term safety and efficacy benefit in CLL/small lymphocytic lymphoma (SLL) to be presented at ASCO and EHA, respectively

NORTH CHICAGO, Ill., May 30, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present more than 40 data updates across its oncology portfolio during the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting on May 31-June 4, in Chicago, and the European Hematology Association (EHA) Annual Congress on June 13-16, in Amsterdam. The data presentations will span the company's investigational and approved oncology portfolio medicines in more than 15 different blood and solid tumor cancers.

For the first time, researchers will also present data from the Phase 3 CLL14 study evaluating venetoclax (VENCLEXTA®/VENCLYXTO®) plus obinutuzumab versus obinutuzumab plus chlorambucil at ASCO (abstract #7502). Results from the trial supported the recent FDA approval of this VENCLEXTA chemotherapy-free combination for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Researchers will also present new, multi-year, long-term data on the use of single-agent ibrutinib (IMBRUVICA®) in CLL/SLL at both ASCO and EHA in 2019. Six years of follow-up data evaluating previously treated patients on ibrutinib therapy from the Phase 3 RESONATETM trial (PCYC-1112) will be presented as a poster discussion at ASCO (abstract #7510), and more than five years of follow-up for previously untreated patients on ibrutinib therapy from the Phase 3 RESONATE-2TM trial (PCYC-1115/1116) will be presented in an oral session at EHA (abstract #S107). The RESONATETM trial's long-term follow-up data presentation was also selected to be featured at the Best of ASCO 2019 Meetings, which highlight cutting-edge science and reflect the leading research and strategies in oncology. Following updates earlier this year, the National Comprehensive Cancer Network® (NCCN®) now recommends ibrutinib (IMBRUVICA®) as a preferred regimen for the initial treatment of CLL/SLL and the only Category 1 single-agent regimen for patients without 17p deletion.1

"The data AbbVie is presenting at ASCO and EHA provide a glimpse into the progress we are making collaboratively advancing a diverse pipeline across a broad range of hematologic malignancies and solid tumors," said Neil Gallagher, M.D., Ph.D., vice president, head of global oncology development, AbbVie. "We continue to make progress with first-in-class medicines like ibrutinib and venetoclax that are approved and are being further investigated as potential treatments for several different forms of hematologic malignancies. AbbVie is also advancing a diverse oncology portfolio of investigational drugs with the potential to address unmet needs in other difficult-to-treat cancers."

IMBRUVICA is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

VENCLEXTA is a first-in-class BCL-2 inhibitor being developed by AbbVie and Roche. VENCLEXTA 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.

To learn more about our work in oncology, visit http://www.abbvie.com/oncology.

Presentations include:

Abstract

Presentation Timing

ASCO Annual Meeting

Ibrutinib

Final Analysis From RESONATE: 6-Year Follow-up
in Patients (Pts) With Previously Treated Chronic
Lymphocytic Leukemia or Small Lymphocytic
Lymphoma (CLL/SLL) on Ibrutinib; Barr et al.;
Abstract #7510

Monday, June 3

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Poster Discussion: 11:30 a.m. - 1:00 p.m. CT

Patient-Reported Outcomes (PROs) With
Ibrutinib-Rituximab in Waldenström
Macroglobulinemia (WM): Results From
iNNOVATE™; Tedeschi et al.; Abstract #8018

Monday, June 3

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Poster Discussion: 1:15 p.m. - 2:45 p.m. CT

Interim Analysis of Ibrutinib Plus Paclitaxel for
Patients With Advanced Urothelial Carcinoma
Previously Treated With Platinum-Based
Chemotherapy; Castellano et al.; Abstract #4522

Monday, June 3

Poster Session: 1:15 p.m. - 4:15 p.m. CT

Venetoclax

Effect of Fixed-Duration Venetoclax Plus
Obinutuzumab (VenG) on Progression-Free
Survival (PFS), and Rates and Duration of Minimal
Residual Disease Negativity (MRD-) in Previously
Untreated Patients (pts) with Chronic
Lymphocytic Leukemia (CLL) and Comorbidities;
Fischer K, et al.; Abstract #7502

Tuesday, June 4

Oral Session: 9:45 a.m. - 12:45 p.m. CT

Oral Presentation: 10:09 a.m. - 10:21 a.m. CT

Outcomes of Patients with t(11;14) Multiple
Myeloma: An International Myeloma Working
Group (IMWG) Multicenter Study; Durie BG, et al.;
Abstract #8015

Monday, June 3

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Poster Discussion: 1:15 p.m. - 2:45 p.m. CT

Randomized Phase 2 Trial of Venetoclax +
Fulvestrant Versus Fulvestrant in Estrogen
Receptor+, HER2- Locally Advanced or Metastatic
Breast Cancer Following Recurrence or
Progression During or After a CDK4/6 Inhibitor:
VERONICA; Lindeman GJ, et al.; Abstract
#TPS1108

Sunday, June 2

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Veliparib

Veliparib in Combination with
Chemoradiotherapy (CRT) of
Carboplatin/Paclitaxel (C/P) Plus Radiation in
Patients with Stage III Non-Small Cell Lung Cancer
(NSCLC); Kozono DE, et al.; Abstract #8510

Sunday, June 2

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Poster Discussion: 11:15 a.m. - 12:45 p.m. CT

Mivebresib

Results from the First-in-Human Study of
Mivebresib (ABBV-075), a Pan-Inhibitor of
Bromodomain and Extra Terminal Proteins, in
Patients with Relapsed/Refractory Acute Myeloid
Leukemia; Odenike O, et al.; Abstract #7030

Monday, June 3

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Cell Free DNA in Uveal Melanoma: Results from
the First in Human Trial of Mivebresib (ABBV-
075); Patel SP, et al.; Online Publication

Online Publication

Depatux-M

Phase 1/2 Study of Depatuxizumab Mafodotin
(ABT-414) Monotherapy or Combination with
Temozolomide in Japanese Patients with/without
EGFR-Amplified Recurrent Glioblastoma; Narita Y,
et al.; Abstract #2065

Sunday, June 2

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Rova-T

Phase 1 Study on Preliminary Efficacy of
Rovalpituzumab Tesirine in Japanese Patients
with Advanced, Recurrent Small Cell Lung Cancer;
Akamatsu H, et al.; Abstract #8557

Sunday, June 2

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Ph1/2 Study of Rova-T in Combination with
Nivolumab (Nivo) ± Ipilimumab (Ipi) for Patients
(Pts) with 2L+ Extensive-Stage (ED) SCLC;
Malhotra J, et al.; Abstract #8516

Sunday, June 2

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Poster Discussion: 11:15 a.m. - 12:45 p.m. CT

Predictors Associated with Development of
Pleural and Pericardial Effusions in Patients with
Small Cell Lung Cancer Treated with Third-Line
Therapy; Jiang R, et al.; Online Publication

Online Publication

Teslio-V

Results of the Phase 1b Study of ABBV-399
(Telisotuzumab Vedotin; Teliso-V) in Combination
with Erlotinib in Patients with c-Met+ Non-Small Cell
Lung Cancer by EGFR Mutation Status;
Camidge DR, et al.; Abstract #3011

Saturday, June 1

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Poster Discussion: 3:00 p.m. - 4:30 p.m. CT

c-Met Expression and Response to Telisotuzumab
Vedotin (Teliso-V) in Patients with Non-Small Cell
Lung Cancer; Heist RS, et al.; Abstract #9023

Sunday, June 2

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Poster Discussion: 4:30 p.m. - 6:00 p.m. CT

Peripheral Neuropathy Among Patients with
NSCLC Undergoing Chemotherapy; Tyczynski JE,
et al.; Online Publication

Online Publication

ABBV-085

First-in-Human Phase 1 Study of ABBV-085, an
Antibody-Drug Conjugate (ADC) Targeting
LRRC15, in Sarcomas and Other Advanced Solid
Tumors; Demetri GD, et al.; Abstract #3004

Monday, June 3

Oral Session: 8:00 a.m. - 11:00 a.m. CT

Oral Presentation: 9:12 a.m. - 9:24 a.m. CT

ABBV-621

Phase 1, First-In-Human Study of TRAIL Receptor
Agonist Fusion Protein ABBV-621; Ratain MJ, et
al.; Abstract #3013

Saturday, June 1

Poster Session: 8:00 a.m. - 11:00 a.m. CT

Poster Discussion: 3:00 p.m. - 4:30 p.m. CT

ABBV-181

Safety and Efficacy of Anti-PD-1 Inhibitor ABBV-
181 in Lung and Head and Neck Carcinoma;
Italiano A, et al.; Online Publication

Online Publication

EHA Annual Congress 

Ibrutinib

Five Year Follow-Up of Patients Receiving
Ibrutinib for First-Line Treatment of Chronic
Lymphocytic Leukemia;
Tedeschi A, et al.; 
Abstract #S107

Monday, June 14

Oral Session: 11:30 a.m. - 12:45 p.m. CEST

Oral Presentation: 12:00 p.m. - 12:15 p.m. CEST

Patient-Reported Outcomes from the
iNNOVATETM Study: Results of Ibrutinib-Rituximab
in Waldenström Macroglobulinemia (WM)
;
Tedeschi A, et al.; Abstract #PF614

Monday, June 14

Poster Display: 5:30 p.m. - 7:00 p.m. CEST

Prognostic Testing and Treatment Approaches
Based on Real-World Clinical Experience from an
Interim Analysis of the INFORMCLL Registry of
Patients with Chronic Lymphocytic Leukemia
;
Mato AR, et al.; Abstract #PF383

Monday, June 14

Poster Display: 5:30 p.m. - 7:00 p.m. CEST

Venetoclax

A Phase 1b/2 Clinical Study of Targeted IDH1
Inhibition with Ivosidenib in Combination with the
BCL-2 Inhibitor Venetoclax for Patients with IDH1-
mutated (mIDH1) Myeloid Malignancies; DiNardo
CD, et al.;  Abstract #PF291

Friday, June 14

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

 

Factors Impacting Treatment Selection in
Treatment-Naïve Patients with CLL: A Multicenter
Study; Rhodes J, et al.; Abstract #PF381

Friday, June 14

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

 

Venetoclax for Chronic Lymphocytic Leukemia: A
Retrospective Chart Review of Safety and Efficacy
From Preapproval Cohort Programs in the
European Union; Schuh, et al.; Abstract #PS1165

Saturday, June 15

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

Venetoclax Alone or in Combination with
Rituximab for Japanese Patients with
Relapsed/Refractory Chronic Lymphocytic
Leukemia; Yamamoto K, et al.; Abstract #PB1890

Online Publication

Efficacy and Safety of Ibrutinib in
Relapsed/Refractory Chronic Lymphocytic
Leukemia in Patients Previously Treated with
Venetoclax in the MURANO Study; Greil R, et al.;
Abstract #PS1161

Saturday, June 15

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

Impact of Major Genomic Alterations on Outcome
of Relapsed/Refractory (R/R) Chronic Lymphocytic
Leukemia (CLL) Patients (Pts) Treated With
Venetoclax Plus Rituximab (Venr) in the Phase 3
MURANO Study; Wu J, et al.; Abstract #PS1123

Saturday, June 15

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

Genetic Markers and Outcome in the CLL14 Trial
of the GCLLSG Comparing Front Line
Obinutuzumab Plus Chlorambucil or Venetoclax in
Patients with Comorbidity; Tausch E, et al.;
Abstract #S105

Friday, June 14

Oral Presentation: 11:30 a.m. - 11:45 a.m. CEST

Updated Safety and Efficacy From a Phase 2
Study of Venetoclax Plus Carfilzomib and
Dexamethasone in Patients with
Relapsed/Refractory Multiple Myeloma;
 Costa LJ,
et al
.; Abstract #PS1375

Saturday, June 15

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

Improved Outcome in Patients With BCL2-Positive
Diffuse Large B-Cell Lymphoma Treated With
Venetoclax Plus R-Chop: Results From the Phase 2
CAVALLI Study;
Morschhauser F, et al.; Abstract
#PF294

Friday, June 14

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

 

Mivebresib

Results From the First-In-Human Study of
Mivebresib (Abbv-075), a Pan-Inhibitor of
Bromodomain and Extra Terminal Proteins, in
Patients With Relapsed/Refractory Acute Myeloid
Leukemia;
Borthakur G, et al.; Abstract #PF254

Friday, June 14

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

 

Navitoclax

Combination BCL-2 Inhibitor Therapy With
Venetoclax (Ven) and Navitoclax (Nav) in Patients
with Relapsed/Refractory (R/R) Acute
Lymphoblastic Leukemia (ALL) and Lymphoblastic
Lymphoma (LL); Pullarkat V, et al.; Abstract
#PS940

Saturday, June 15

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

Additional Research

Outcomes Of Patients With t(11;14) Multiple
Myeloma: An International Myeloma Working
Group Multicenter Study; Kumar S, et al.; Abstract
#PF564

Friday, June 14

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

 

Longitudinal Treatment Patterns and Patient
Characteristics Among Individuals Diagnosed
With CLL in Israel; Weil C, et al.; Abstract #PS1166

Saturday, June 15

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

Patient Characteristics, Transplant Frequency,
and Treatments in Multiple Myeloma; Karve S, et
al.; Abstract #PF724

Friday, June 14

Poster Session: 5:30 p.m. - 7:00 p.m. CEST

 

 

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.2

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.  Venetoclax is not approved by any regulatory authority, in any country for the treatment of multiple myeloma.

Uses and Important VENCLEXTA® (venetoclax) U.S. Safety Information2

Use
VENCLEXTA is a prescription medicine used:

  • to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • in combination with azacytidine, 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.

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

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 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 http://www.fda.gov/medwatch or call 1-800-FDA-1088.

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

Please see full Prescribing Information, including Medication Guide.

Important VENCLYXTO® (venetoclax) EU Safety Information3

VENCLYXTO (venetoclax) Indication 
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia(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 chemo immunotherapy 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
Tumor lysis syndrome (TLS), including fatal events, has occurred in patients with previously treated CLL with high tumor 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 events of sepsis with fatal outcome have been reported. Supportive measures including antimicrobials for any signs of infection should be considered.

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 in patients receiving venetoclax in the combination study with rituximab were neutropenia, diarrhea, and upper respiratory tract infection. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhea, nausea, anemia, fatigue, and upper respiratory tract infection.

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

Discontinuation due to adverse reactions occurred in 16% of patients receiving venetoclax plus rituximab and 9% receiving venetoclax monotherapy. Dosage adjustments due to adverse reactions occurred in 15% of patients receiving venetoclax plus rituximab and 2% receiving venetoclax monotherapy. Dose interruptions occurred in 71% of patients treated with the combination of venetoclax and rituximab. 

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. VENCLYXTO should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.

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 www.ema.europa.eu. 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. 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://www.abbvie.com/oncology.

About IMBRUVICA

IMBRUVICA (ibrutinib) is an oral, once-daily medicine that works differently than chemotherapy, as it blocks a protein called Bruton's tyrosine kinase (BTK). 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.4,5 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.6

Since its launch in 2013, IMBRUVICA has received 10 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL), and previously-treated chronic graft-versus-host disease (cGVHD).7 IMBRUVICA is now approved in more than 95 countries and has been used to treat more than 135,000 patients worldwide across its approved indications.

  • IMBRUVICA was first approved for adult patients with MCL who have received at least one prior therapy in November 2013.*
  • Soon after, IMBRUVICA was initially approved in adult CLL patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
  • IMBRUVICA was approved for adult patients with WM in January 2015.
  • In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with previously treated CLL/SLL.
  • In January 2017, IMBRUVICA was approved for adult patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.*
  • In August 2017, IMBRUVICA was approved for adult patients with cGVHD who failed to respond to one or more lines of systemic therapy.
  • In August 2018, IMBRUVICA was approved in combination with rituximab for adult patients with WM.
  • In January 2019, IMBRUVICA was approved in combination with obinutuzumab (Gazyva) for previously untreated adult patients with CLL/SLL.

IMBRUVICA is the only FDA-approved medicine in WM, MZL* 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.8 IMBRUVICA was one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway.

The National Comprehensive Cancer Network® (NCCN®) recommends ibrutinib (IMBRUVICA®) as a preferred regimen for the initial treatment of CLL/SLL and the only Category 1 single-agent regimen for patients without 17p deletion.1  

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is an extensively and 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 treated with IMBRUVICA®.  Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) have occurred in 3% of patients, with fatalities occurring in 0.3% of 1,124 patients exposed to IMBRUVICA® in clinical trials.  Bleeding events of any grade, including bruising and petechiae, occurred in 44% 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 24% of 1,124 patients exposed to 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: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (23%), thrombocytopenia (8%), and anemia (3%) based on laboratory measurements occurred in patients with B?cell malignancies treated with single agent IMBRUVICA®.

Monitor complete blood counts monthly.

Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA® therapy.  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 1,124 patients exposed to 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 of any grade occurred in 12% of 1,124 patients treated with IMBRUVICA® in clinical trials. Grade 3 or greater hypertension occurred in 5% of patients with a median time to onset of 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%) have occurred in 1,124 patients treated with 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® 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 (58%)*, diarrhea (41%), anemia (38%)*, neutropenia (35%)*, musculoskeletal pain (32%), rash (32%), bruising (31%), nausea (26%), fatigue (26%), hemorrhage (24%), and pyrexia (20%).

The most common Grade 3 or 4 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (18%)*, thrombocytopenia (16%)*, and pneumonia (14%).

Approximately 7% (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: Modify IMBRUVICA® dose as described 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 IMBRUVICA® dose.

Please click here for full Prescribing Information.

About AbbVie

AbbVie is a global, research and development-based 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, LinkedIn or Instagram.

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 2018 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 National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. May 2019. https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed May 2019.
2 VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL.: AbbVie Inc.
3 Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.
4 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed January 2019.
5 Turetsky, et al. Single cell imaging of Bruton's Tyrosine Kinase using an irreversible inhibitor. Scientific Reports. volume 4, Article number: 4782 (2014).
6 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.
7 IMBRUVICA U.S. Prescribing Information, January 2019
8 U.S. Food and Drug Administration. Fact sheet: breakthrough therapies. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed June 2018.

 

SOURCE AbbVie

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