NORTH CHICAGO, Ill., May 18, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, will present data from multiple clinical trials evaluating the company's portfolio of approved and investigational oncology medicines during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO), June 3-7, in Chicago. Notably, researchers will present data from studies evaluating Venclexta (venetoclax), a BCL-2 inhibitor being developed by AbbVie and Genentech, a member of the Roche Group, and IMBRUVICA® (ibrutinib), an inhibitor of Bruton's tyrosine kinase (BTK), across multiple hematologic malignancies.
Additionally, researchers will present data on ABT-414, an investigational antibody-drug conjugate (ADC), as monotherapy in epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM),1 an aggressive malignant primary brain tumor.2
Data on Venclexta will be featured in the "Best of ASCO" program and presented in cities across the country. "Best of ASCO" features the top abstracts, highlighting the most cutting-edge science and education from the annual meeting.
"The multiple data presentations we will be making at ASCO 2016 underscore AbbVie's commitment to pursue new cancer therapy options, with the potential to make a real and remarkable impact on the lives of people affected by cancer," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "AbbVie is committed to working together with the oncology research community, healthcare and clinical experts, industry peers, patients and patient advocacy groups, to discover and develop therapies with the goal of transforming the treatment of cancer."
AbbVie abstracts:
Venclexta (venetoclax)
- Phase 1b/2 study of venetoclax with low-dose cytarabine in treatment-naïve patients aged 65 years with acute myelogenous leukemia; Lin et al.; Abstract 7007; Oral Presentation; Saturday, June 4, 2016; 3-6 p.m. CDT
- Results of a phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients 65 years ineligible for standard induction therapy; Pollyea et al.; Abstract 7009; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT with Poster Discussion Monday, June 6, 2016; 11:30 a.m.-12:45 p.m. CDT (abstract selected for "Best of ASCO" program)
- Phase 1 venetoclax monotherapy for relapsed/refractory multiple myeloma; Kumar et al.; Abstract 8032; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT
- Phase 1b venetoclax combined with bortezomib and dexamethasone in relapsed/refractory multiple myeloma; Moreau et al.; Abstract 8011; Oral Presentation; Tuesday, June 7, 2016; 9:45-11:15 a.m. CDT
- Safety, efficacy and immune effects of venetoclax 400 mg daily in patients with relapsed chronic lymphocytic leukemia; Davids et al.; Abstract 7527; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT
- Venetoclax activity in CLL patients who have relapsed after or are refractory to ibrutinib or idelalisib; Jones et al.; Abstract 7519; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT with Poster Discussion Monday, June 6, 2016; 1:15-2:45 p.m. CDT
- Integrated safety analysis of venetoclax monotherapy in chronic lymphocytic leukemia; Davids et al.; Abstract 7528; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT
- Phase 1b study of venetoclax plus R- and G-CHOP in patients with B-cell non-Hodgkin lymphoma; Zelentz et al.; Abstract 7566; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT
Imbruvica® (ibrutinib)
- A phase 1b/2 study of ibrutinib combination therapy in selected advanced genitourinary and gastrointestinal tumors; Berlin et al.; Abstract TPS2600; Poster Session; Sunday, June 5, 2016; 8-11:30 a.m. CDT
- A randomized, double-blind, placebo-controlled study of ibrutinib, a Bruton Tyrosine Kinase inhibitor, with nab-paclitaxel and gemcitabine in the first-line treatment of patients with metastatic pancreatic adenocarcinoma (RESOLVE); Tempero et al.; Abstract TPS2601; Poster Session; Sunday, June 5, 2016; 8-11:30 a.m. CDT
- Ibrutinib (I) plus bendamustine and rituximab (BR) in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): a 2-year follow-up of the HELIOS study; Fraser et al.; Abstract 7525; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT
- Sequence variants in patients with primary and acquired resistance to ibrutinib in the phase 3 MCL3001 (RAY) trial; Lenz et al.; Abstract 7570; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT
- Outcomes with ibrutinib by line of therapy in patients with CLL: Analyses from phase 3 data; O'Brien et al.; Abstract 7520; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT with Poster Discussion Monday, June 6, 2016; 1:15-2:45 p.m. CDT
Empliciti (elotuzumab)
- Health care resource utilization (HCRU) in relapsed/refractory multiple myeloma (RRMM): results from PREAMBLE; Goldschmidt et al.; Abstract 6621; Poster Session; Saturday, June 4, 2016; 1-4:30 p.m. CDT
- A randomized phase 2 study of pomalidomide/dexamethasone with or without elotuzumab in patients with relapsed/refractory multiple myeloma; San Miguel et al.; Abstract TPS8066; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT
- ELOQUENT-2 update: Phase III study of elotuzumab plus lenalidomide/dexamethasone (ELd) vs Ld in relapsed/refractory multiple myeloma (RRMM)Identifying responders by subset analysis; Lonial et al.; Abstract 8037; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT
ABT-414
- Efficacy of a novel antibody-drug conjugate (ADC), ABT-414, as monotherapy in epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM); van den Bent et al.; Abstract 2542; Poster Session; Sunday, June 5, 2016; 8-11:30 a.m. CDT
Duvelisib
- FRESCO: A phase 2, randomized study of duvelisib plus rituximab vs R-CHOP in patients with relapsed/refractory follicular lymphoma who have progressed within 24 months of receiving an alkylator-based chemotherapy regimen; Fowler et al.; Abstract TPS7578; Poster Session; Monday, June 6, 2016; 8-11:30 a.m. CDT
- Preliminary safety, pharmacokinetics, and pharmacodynamics of duvelisib plus rituximab or obinutuzumab in subjects with previously untreated CD20+ follicular lymphoma; Casulo et al.; Abstract e19052; Publication
Veliparib
- Veliparib (ABT-888) extended release formulations: A phase 1 study on safety, pharmacokinetics (PK), and bioavailability in patients with advanced solid tumors; Werner et al.; Abstract 2579; Poster Session; Sunday, June 5, 2016; 8-11:30 a.m. CDT
ABBV-399
- Phase 1, open-label, dose-escalation and expansion study of ABBV-399, an antibody drug conjugate (ADC) targeting c-Met, in patients (pts) with advanced solid tumors; Strickler et al.; Abstract 2510; Poster Session; Sunday, June 5, 2016; 8-11:30 a.m. CDT with Poster Discussion Sunday, June 5, 2016; 11:30 a.m.-12:45 p.m. CDT
ABT-165
- Phase 1, open-label, dose-escalation and expansion study of ABT-165, a dual variable domain immunoglobulin (DVD-Ig) targeting both DLL4 and VEGF, in patients (pts) with advanced solid tumors; Gordon et al.; Abstract 2507; Oral Presentation; Monday, June 6, 2016; 8-11 a.m. CDT
The ASCO 2016 Annual Meeting abstracts are available at http://am.asco.org/abstracts.
About Venclexta in the U.S.
Venclexta is an oral B-cell lymphoma-2 (BCL-2) inhibitor indicated in the U.S. for the treatment of patients with relapsed/refractory CLL with 17p deletion, as detected by an FDA-approved test.3 The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.3 Venclexta is designed to selectively inhibit the BCL-2 protein.3 Venclexta was developed in collaboration with Genentech and Roche. Together, the companies are committed to BCL-2 research with Venclexta, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory and first-line CLL, along with early phase studies in several cancers. AbbVie is currently working with regulatory agencies around the world to bring this medicine to eligible patients in need.
The full 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.
Use
VENCLEXTA (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.
U.S. 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.
- Tell your doctor 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 doctor.
What should I tell my doctor before taking VENCLEXTA?
Before taking VENCLEXTA, tell your doctor 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 doctor tells you it is okay.
- Are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA.
- 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 count (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your doctor will do blood tests to check your blood counts during treatment with VENCLEXTA. Tell your doctor right away if you have a fever or any signs of an infection.
The most common side effects of VENCLEXTA include 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.
About IMBRUVICA 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.1,4 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.1
IMBRUVICA is approved to treat patients with CLL/SLL, patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and patients with Waldenström's macroglobulinemia. Accelerated approval was granted for the MCL indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.1
IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway.
IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers. More than 6,000 patients have been treated with IMBRUVICA in clinical trials. Currently, 14 Phase 3 trials have been initiated with IMBRUVICA and more than 90 trials are registered on www.clinicaltrials.gov.
Patient Access to IMBRUVICA
AbbVie and Janssen strive to make access to IMBRUVICA easy by helping patients understand their insurance benefits for IMBRUVICA. The YOU&i Support Program is a personalized program that includes information on access and affordability, nurse call support and resources for patients being treated with IMBRUVICA. This includes the YOU&i Instant Savings program, which provides co-pay support to eligible commercially insured IMBRUVICA patients. Patients can access the program by contacting 1-877-877-3536, option 1 or by visiting http://www.IMBRUVICA.com.
The YOU&i Instant Savings program is not available for patients enrolled in Medicare or Medicaid. For a list of patient support organizations that may be able to provide financial support please visit: http://www.cancer.net/navigating-cancer-care/financial-considerations/financial-resources.
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.
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