AbbVie Demonstrates Progress in Oncology Research at ASCO 2016 Annual Meeting with Multiple Abstracts Evaluating Eight Medicines Across Cancer Types
- Additional data evaluate AbbVie pipeline medicines in advanced solid tumors
- Multiple data presentations, including one selected as a "Best of ASCO" presentation, underscore AbbVie's growing oncology portfolio
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."
- 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
- 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
- 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
- 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
- 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 (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
- 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
- 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.
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. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and postsurgery depending upon the type of surgery and the risk of bleeding.
Infections - Fatal and nonfatal infections have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA®. Evaluate patients for fever and infections and treat appropriately.
Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, 0% to 9%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA®. Monitor complete blood counts monthly.
Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6% to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines.
Hypertension - Hypertension (range, 6% to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new-onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®. Adjust existing antihypertensive medications and/or initiate antihypertensive treatment as appropriate.
Second Primary Malignancies - Other malignancies (range, 5% to 16%) including non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 4% to 13%).
Tumor Lysis Syndrome - Tumor lysis syndrome has been infrequently reported with IMBRUVICA® therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate.
Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
The most common adverse reactions (?20%) in patients with B-cell malignancies (MCL, CLL/SLL, and WM) were neutropenia* (64%), thrombocytopenia* (63%), diarrhea (43%), anemia*(41%), musculoskeletal pain (30%), rash (29%), nausea (29%), bruising (29%), fatigue (27%), hemorrhage (21%), and pyrexia 21%).
*Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased).
The most common Grade 3 or 4 non-hematologic adverse reactions (?5%) in MCL patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin infections (5%).
Approximately 6% (CLL), 14% (MCL), and 11% (WM) of patients had a dose reduction due to adverse reactions.
Approximately 4%-10% (CLL), 9% (MCL), and 6% (WM) of patients discontinued due to adverse reactions. Most frequent adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash and neutropenia (1% each) in CLL patients and subdural hematoma (1.8%) in MCL patients.
CYP3A Inhibitors - Avoid coadministration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose.
CYP3A Inducers - Avoid coadministration with strong CYP3A inducers.
Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose.
Please see Full Prescribing Information: http://www.imbruvica.com/downloads/Prescribing_Information.pdf.
About Empliciti in the U.S.
Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.5
Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.5
On November 30, 2015, the U.S. Food and Drug Administration approved Empliciti in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received one to three prior therapies.5 The safety and efficacy of Empliciti is still being evaluated by other health authorities. Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.
EMPLICITI (elotuzumab) INDICATIONS & IMPORTANT SAFETY INFORMATION
EMPLICITI™ (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.
- In a clinical trial of patients with multiple myeloma (n=365), EMPLICITI caused infusion reactions. Common symptoms include fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose. If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.
- Premedicate with dexamethasone, H1 Blocker, H2 Blocker, and acetaminophen prior to infusing with EMPLICITI.
- Infections were reported in 81.4% of patients in the EMPLICITI with lenalidomide/dexamethasone arm (ERd) and 74.4% in the lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28% (ERd) and 24.3% (Rd). Opportunistic infections were reported in 22% (ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and 5.4% (Rd). Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Monitor patients for development of infections and treat promptly.
Second Primary Malignancies
- Invasive second primary malignancies (SPM) were 9.1% (ERd) and 5.7% (Rd). The rate of hematologic malignancies was the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd). Monitor patients for the development of SPMs.
- Elevations in liver enzymes (AST/ALT greater than 3 times the upper limit, total bilirubin greater than 2 times the upper limit, and alkaline phosphatase less than 2 times the upper limit) consistent with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients experiencing hepatotoxicity discontinued treatment; however, 6 out of 8 patients had resolution and continued treatment. Monitor liver enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation of liver enzymes. After return to baseline values, continuation of treatment may be considered.
Interference with Determination of Complete Response
- EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Pregnancy/Females and Males of Reproductive Potential
- There are no studies with EMPLICITI with pregnant women to inform any drug associated risks.
- There is a risk of fetal harm, including severe life-threatening human birth defects associated with lenalidomide and it is contraindicated for use in pregnancy. Refer to the lenalidomide full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.
- Infusion reactions were reported in approximately 10% of patients treated with EMPLICITI with lenalidomide and dexamethasone. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients.
- Serious adverse reactions were 65.4% (ERd) and 56.5% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15.4%, 11%), pyrexia (6.9%, 4.7%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
- The most common adverse reactions in ERd and Rd, respectively (>20%) are fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%), and pneumonia (20.1%, 14.2%).
Please see the full Prescribing Information here.
ABT-414 is an investigational monoclonal antibody drug conjugate (ADC) targeting EGFR (epidermal growth factor receptor) developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics.1 It is being evaluated for the treatment of patients with EGFR amplified glioblastoma, an aggressive malignant primary brain tumor.1,2 In 2014, the FDA and the European Medicines Agency granted orphan drug designation for the treatment of glioblastoma and glioma, respectively.6,7 ABT-414 is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells.8 PI3K signaling may lead to the proliferation of malignant B-cells, and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.8,9,10 AbbVie and Infinity Pharmaceuticals, Inc. are jointly researching and developing duvelisib in various cancer types.
Duvelisib is being evaluated in several studies, including a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma,11 a Phase 3 study in combination with other agents in patients with previously treated follicular lymphoma,12 and a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia.13 Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types.14 PARP is a naturally-occurring enzyme in the body involved in the repair of DNA damage to cells.15 Discovered by AbbVie researchers, veliparib is being investigated in combination with therapies like chemotherapy or radiation.14 Veliparib is currently being studied in multiple cancers and tumor types, including Phase 3 studies in advanced non-small cell lung cancer and breast cancer. Veliparib is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.
About ABT-165 and ABBV-399
ABT-165 is an investigational medicine being studied in Phase 1 trials for the treatment of patients with advanced solid tumors.16 ABBV-399 is an investigational antibody-drug conjugate (ADC) being studied in a Phase 1 clinical trial in patients with solid tumors.17 These are investigational compounds and their safety and efficacy have not been evaluated by the FDA or any other health authority.
About Pharmacyclics, An AbbVie Company
Pharmacyclics LLC, a wholly-owned subsidiary of AbbVie (NYSE: ABBV), is focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune-mediated diseases. Pharmacyclics' mission is to develop and commercialize novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs.
Pharmacyclics markets IMBRUVICA and has two product candidates in clinical development and several preclinical molecules in lead optimization. Pharmacyclics is committed to high standards of ethics, scientific rigor and operational efficiency as it moves each of these programs toward commercialization. To learn more, please visit www.pharmacyclics.com.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries.
For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
About AbbVie in Oncology
AbbVie is striving to outsmart cancer by working with scientists, physicians, industry peers, patient advocacy groups and most importantly patients, to discover, develop and provide new therapies that will have a remarkable impact on the lives of people around the world affected by cancer. Our goal is to provide medicines that make a transformational improvement in cancer treatment and outcomes for cancer patients. By exploring and investing in new pathways, technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers. We are also exploring solutions to help patients obtain access to our cancer medicines. With the acquisition of Pharmacyclics in 2015, and through several collaborations, AbbVie's oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly two hundred clinical trials in 20 different tumor types. For more information about AbbVie Oncology, please visit http://oncology.abbvie.com.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2015 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 Van den Bent M et al. Efficacy of a novel antibody-drug conjugate (ADC), ABT-414, as monotherapy in epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM). Poster presentation #2542; presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, June 5, 2016.
2 Omuro A and DeAngelis L Glioblastoma and other malignant gliomas: A clinical review. JAMA. 2013;310(17):1842-1850.
3 Venclexta [Package Insert]. North Chicago, Ill.: AbbVie Inc.
4 Genetics Home Reference. Isolated growth hormone deficiency. Available from: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed May 2016.
5 Empliciti [Package Insert]. Princeton, N.J.: Bristol-Myers Squibb Company.
6 U.S. Food and Drug Administration (2014). Orphan Drug Designations and Approvals. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=433214. Accessed May 2016.
7 European Medicines Agency (2014). Public summary of opinion of orphan designation. http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2014/09/WC500171954.pdf. Accessed May 2016.
8 Winkler DG, Faia KL, DiNitto JP et al. PI3K-d and PI3K-g inhibition by IPI_145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol 2013;20:1-11.
9 Reif K et al. Cutting Edge: Differential roles for phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
10 Schmid M et al. Receptor tyrosine kinases and TLR/IL1Rs unexpectedly activate myeloid cell PI3K, a single convergent point promoting tumor inflammation and progression. Cancer Cell 2011;19:715-727.
11 www.clinicaltrials.gov, NCT01882803
12 www.clinicaltrials.gov, NCT02576275
13 www.clinicaltrials.gov, NCT02004522
14 Donawho CK, Luo Y, Luo Y, et al. ABT-888, an orally active poly(ADP-ribose) polymerase inhibitor that potentiates DNA-damaging agents in preclinical tumor models. Clin Cancer Res. 2007;13(9):2728-2737.
15 Horton J, Stefanick D, Prasad R, Gassman N, Kedar P and Wilson S. Base excision repair defect invoke hyper sensitivity to PARP inhibition. Mol Cancer Res. 2014; 12(8): 1128-39.
16 Gordon M et al. 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. Oral presentation #2507; presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, June 6, 2016.
17 Strickler J et al. 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. Poster discussion #2510; presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, June 5, 2016.