Full Press Release Details
NORTH CHICAGO, Ill. , May 16, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV ), a research-based global biopharmaceutical company, today announced it will present data about the company's portfolio of investigational oncology medicines during the American Society of Clinical Oncology (ASCO) Annual Meeting, June 1-5 , in Chicago . More than 30 abstracts have been accepted, featuring data in hematologic malignancies and several solid tumor types, including brain cancer and lung cancer.
Researchers will present data across multiple hematologic malignancies evaluating venetoclax, a first-in-class BCL-2 inhibitor developed by AbbVie and Genentech, and ibrutinib, an inhibitor of Bruton's tyrosine kinase (BTK).
Additionally, updated data will be featured from AbbVie's late-stage investigational products including depatuxizumab mafodotin (depatux-m; previously known as ABT-414), an antibody-drug conjugate (ADC), in amplified-epidermal growth factor receptor (EGFR) recurrent glioblastoma (rGBM); rovalpituzumab tesirine (Rova-T), an investigational ADC targeting delta-like protein 3 (DLL3)-expressing tumors, in small cell lung cancer (SCLC); veliparib, an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor, across multiple solid tumors; elotuzumab, an immunostimulatory antibody that specifically targets signaling lymphocyte activation molecule family member 7 (SLAMF7), a cell-surface glycoprotein; as well as other early-stage investigational compounds, including ABBV-075 (Mivebresib), ABT-165 and PF-06647020 (PF-7020).
In oncology discovery and early development, AbbVie utilizes key therapeutic pathways and methods to identify appropriate options to treat people living with cancer. Abstracts at ASCO 2018 will also show progress in AbbVie's discovery and early development efforts.
"AbbVie's data at ASCO 2018 reinforces the potential of our robust oncology portfolio, focused on helping patients impacted by several different cancers where few durable treatment options exist," said Neil Gallagher , M.D., vice president and head of global oncology development, AbbVie. "We concentrate our efforts on delivering meaningful medicines for patients, and are committed to advancing science aimed at the most difficult-to-treat cancers."
To learn more about our work in oncology, visit http://abbvieoncology.com .
AbbVie abstracts include:
Depatuxizumab mafodotin (depatux-m; ABT-414)
Rovalpituzumab tesirine (Rova-T)
ABBV-075 (Mivebresib)
Bromodomain and Extra-Terminal motif (BET) inhibitors
Immuno-Oncology
PF-06647020 (PF-7020)
The ASCO 2018 Annual Meeting abstracts are available at http://am.asco.org/abstracts .
These investigational agents and the approved drugs venetoclax, ibrutinib and elotuzmab are being studied for unapproved uses or regimens where safety and efficacy have not been established.
About IMBRUVICA ®
IMBRUVICA ® (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by blocking a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells as well as other serious, debilitating conditions. 1,2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably. 1
IMBRUVICA has been granted four Breakthrough Therapy Designations from the FDA, including in cGVHD. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. 3 IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway.
IMBRUVICA is FDA-approved in six distinct patient populations: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and previously-treated chronic graft-versus-host-disease (cGVHD). 1
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. 1
IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, 90,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.
Patient Access to IMBRUVICA AbbVie and Janssen strive to make access to IMBRUVICA easy by helping patients in the U.S. understand their insurance benefits for IMBRUVICA. The YOU&i™ Support Program is a program that includes information on access and affordability support options, nurse call support and resources for patients being treated with IMBRUVICA.
IMBRUVICA ® (ibrutinib) U.S. IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA ® . Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA ® .
The mechanism for the bleeding events is not well understood.
IMBRUVICA ® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding.
Consider the benefit-risk of withholding IMBRUVICA ® for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.
Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA ® therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA ® . Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.
Monitor and evaluate patients for fever and infections and treat appropriately.
Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 13%) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent IMBRUVICA ® .
Monitor complete blood counts monthly.
Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA ® therapy. Grade 3 or greater ventricular tachyarrhythmias occurred in 0 to 1% of patients, and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 0 to 6% of patients. 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 (range, 6 to 17%) has occurred in patients treated with IMBRUVICA ® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA ® .
Adjust existing anti-hypertensive medications and/or initiate anti-hypertensive treatment as appropriate.
Second Primary Malignancies: Other malignancies (range, 3 to 16%) including non-skin carcinomas (range, 1 to 4%) have occurred in patients treated with IMBRUVICA ® . The most frequent second primary malignancy was non-melanoma skin cancer (range, 2 to 13%).
Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA ® therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions.
Monitor patients closely and treat as appropriate.
Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA ® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA ® and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period.
ADVERSE REACTIONS
B-cell malignancies: The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (62%), neutropenia (61%), diarrhea (43%), anemia (41%)*, musculoskeletal pain (30%), bruising (30%), rash (30%), fatigue (29%), nausea (29%), hemorrhage (22%), and pyrexia (21%).
The most common Grade 3 or 4 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (39%), thrombocytopenia (16%), and pneumonia (10%).
Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9 % (WM [6%] and MZL [13%]) of patients discontinued due to adverse reactions.
cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%), stomatitis (29%), muscle spasms (29%), nausea (26%), hemorrhage (26%), anemia (24%), and pneumonia (21%).
The most common Grade 3 or 4 adverse reactions (≥5%) reported in patients with cGVHD were fatigue (12%), diarrhea (10%), neutropenia (10%)*, pneumonia (10%), sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).
Twenty-four percent of patients receiving IMBRUVICA ® in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.
*Treatment-emergent decreases (all grades) were based on laboratory measurements and adverse reactions.
DRUG INTERACTIONS
CYP3A Inhibitors: Dose adjustment may be recommended.
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 see Full Prescribing Information: https://www.imbruvica.com/prescribing-information .
About VENCLEXTA ® (venetoclax) in the U.S. VENCLEXTA is an oral B-cell lymphoma-2 (BCL-2) inhibitor developed by AbbVie and Genentech, a member of the Roche Group. VENCLEXTA targets a specific protein in the body called BCL-2.[4] When you have CLL, BCL-2 may build up and prevent cancer cells from self-destructing naturally. VENCLEXTA targets BCL-2 in order to help restore the process of apoptosis. 4 Through apoptosis, your body allows cancer cells and normal cells to self-destruct.
VENCLEXTA has been granted four Breakthrough Therapy Designations from the FDA including for the combination treatment of patients with untreated AML not eligible for standard induction chemotherapy. This designation is intended to expedite the development and review of therapies for serious or life-threatening conditions. 3 In January 2016, AbbVie announced that the FDA granted priority review for the single agent NDA application for VENCLEXTA.
In April 2016, U.S. FDA granted accelerated approval of VENCLEXTA for the treatment of patients with relapsed/refractory CLL with 17p deletion, as detected by an FDA-approved test. 4 This indication is approved under accelerated approval based on overall response rate. 4 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 4
AbbVie and Genentech are committed to BCL-2 research with venetoclax, which is currently being evaluated in combination with other agents in Phase 3 clinical trials for the treatment of relapsed/refractory and first-line CLL, 5 along with early phase studies in several cancers. 4,6,7,8,9
Venetoclax is under evaluation by health authorities in multiple countries, and is currently approved in more than 49 nations, including the U.S.
What is VENCLEXTA ® (venetoclax)? 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.
VENCLEXTA was approved based on response rate. There is an ongoing study to find out how VENCLEXTA works over a longer period of time.
It is not known if VENCLEXTA is safe and effective in children.
Important Safety Information What is the most important information I should know about VENCLEXTA? VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your doctor will do tests for TLS. It is important to keep your appointments for blood tests. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Tell your doctor right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.
Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.
Who should not take VENCLEXTA? Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased.
What should I tell my doctor before taking VENCLEXTA? Before taking VENCLEXTA, tell your doctor about all of your medical conditions, including if you:
What should I avoid while taking VENCLEXTA? You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.
What are the possible side effects of VENCLEXTA? VENCLEXTA can cause serious side effects, including:
The most common side effects of VENCLEXTA include low white blood cell count, diarrhea, nausea, low red blood cell count, upper respiratory tract infection, low platelet count, and feeling tired.
VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your doctor if you have concerns about fertility.
These are not all the possible side effects of VENCLEXTA. Tell your doctor if you have any side effect that bothers you or that does not go away.
The full U.S. prescribing information for VENCLEXTA can be found here .
Patient Assistance Program For those who qualify, AbbVie and Genentech offer patient assistance programs for people taking Venclexta in the U.S.
About EMPLICITI™ (elotuzumab) in the U.S. EMPLICITI is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage. 10
EMPLICITI has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. EMPLICITI also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.
On November 30, 2015, the U.S. Food and Drug Administration (FDA) approved EMPLICITI in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received one to three prior therapies. The safety and efficacy of EMPLICITI is still being evaluated by other health authorities. Bristol-Myers Squibb and AbbVie are co-developing EMPLICITI, with Bristol-Myers Squibb solely responsible for commercial activities.
EMPLICITI™ (elotuzumab) U.S. IMPORTANT SAFETY INFORMATION
WHAT IS EMPLICITI? EMPLICITI™ (elotuzumab) is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in people who have received one to three prior treatments for their multiple myeloma.
It is not known if EMPLICITI is safe and effective in children.
IMPORTANT SAFETY INFORMATION EMPLICITI is used in combination with REVLIMID and dexamethasone. It is important to remember that the safety information for these medications also applies to EMPLICITI combination therapy.
Before you receive EMPLICITI, tell your healthcare provider about all of your medical conditions, including if you: