News

NORTH CHICAGO, Ill., May 17, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced it will present data about the company's portfolio of approved and investigational oncology medicines during the 53^rd Annual Meeting of the American Society of Clinical Oncology (ASCO), June 2-6, in Chicago. A total of 23 abstracts have been accepted across several tumor types including brain cancer, hematologic malignancies, breast cancer, lung cancer and other solid tumors.

Researchers will present efficacy and safety data on depatuxizumab mafodotin (previously known as ABT-414), an antibody-drug conjugate (ADC) being studied for the treatment of adults with amplified-epidermal growth factor receptor (EGFR) newly diagnosed or recurrent glioblastoma (GBM). GBM is one of the most aggressive cancers, with a five-year survival rate of approximately 6 percent in the U.S. and 24 European countries.^1,2 The most common genetic alteration in GBM, EGFR-amplification, occurs in approximately 50 percent of GBM patients.^3,4

Additionally, researchers will present data from studies evaluating venetoclax, a BCL-2 inhibitor developed by AbbVie and Genentech, a member of the Roche Group, for investigational uses across multiple hematologic malignancies; ibrutinib, an inhibitor of Bruton's tyrosine kinase (BTK), across multiple hematologic malignancies and chronic graft versus host disease (cGVHD); 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; and other early-stage investigational compounds.

AbbVie will also share early-stage research from its oncology pipeline. AbbVie is utilizing technologies and new approaches to help advance cancer therapies that may become foundational to the next generation of cancer treatments. 

"AbbVie's data presentations at this year's ASCO meeting reinforce our diverse and comprehensive oncology pipeline, focused on bringing new medicines to patients, especially in areas where few options exist in cancer," said Tom Hudson, M.D., vice president of oncology discovery and early development, AbbVie. "By combining our deep knowledge in core areas of biology with cutting-edge technologies, and working together with our partners including scientists, industry peers and patients, we aim to discover and develop medicines that will drive transformational improvements in cancer treatment."

AbbVie abstracts:

Ibrutinib

• Long-Term Efficacy and Safety with Ibrutinib (ibr) in Previously Treated Chronic Lymphocytic Leukemia (CLL): Up to Four Years Follow-Up of the RESONATE Study; Byrd et al.; Abstract 7510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 1:15 p.m.-2:30 p.m. CDT
• Ibrutinib vs Chlorambucil: Immunophenotypic and Quantitative Impacts on Circulating Immune Cells in Chronic Lymphocytic Leukemia (CLL); Solman et al.; Abstract 7524; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
• A Randomized, Double-Blind Phase III Study of Ibrutinib versus Placebo in Combination with Corticosteroids in Patients with New Onset Chronic Graft Versus Host Disease; Miklos et al.; Abstract TPS7072; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab Versus Placebo in Combination with Rituximab in Patients with Treatment-Naïve Follicular Lymphoma (PERSPECTIVE); Fowler et al.; Abstract TPS7576; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.- 11:30 a.m. CDT

Venetoclax

• Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Venetoclax Combined with Azacitidine Versus Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia; Potluri et al.; Abstract TPS7069; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
• Phase 2, Open-Label Study of Venetoclax in Combination with Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma; Bueno et al.; Abstract TPS8056; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
• Venetoclax (VEN) in Patients with Relapsed Non-Hodgkin Lymphoma (NHL); Davids et al.; Publication

Depatuxizumab mafodotin (ABT-414)

• Efficacy Analysis of ABT-414 with or without Temozolomide (TMZ) in Patients (pts) with EGFR-Amplified, Recurrent Glioblastoma (rGBM) from a Multicenter, International Phase I Clinical Trial; van den Bent et al.; Abstract 2003; Oral Presentation; Sunday, June 4, 2017; 9:00 a.m.-9:12 a.m. CDT

Rovalpituzumab tesirine (Rova-T)

• A Phase III Study of Rovalpituzumab Tesirine Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients with Extensive Disease Small Cell Lung Cancer (ED SCLC); Komarnitsky et al.; Abstract TPS8583; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
• Molecular Profiling of Small Cell Bladder Cancer (SCBC) to Reveal Gene Expression Determinants of Aggressive Phenotype; Koshkin et al.; Abstract 4529; Poster Presentation; Sunday, June 4, 2017; 8:00 a.m.-11:30 a.m. CDT
• A Study of Rovalpituzumab Tesirine in Frontline Treatment of Patients with DLL3 Expressing Extensive Small Cell Lung Cancer; Hann et al.; Abstract TPS2598; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
• An Open-Label Study of Rovalpituzumab Tesirine in Patients with DLL3-Expressing Advanced Solid Tumors; Kavalerchik et al.; Abstract TPS2597; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
• Rovalpituzumab Tesirine (Rova-T) as a Therapeutic Agent for Neuroendocrine Prostate Cancer (NEPC); Puca et al.; Abstract 5029; Poster Presentation; Monday, June 5, 2017; 1:15 p.m.-4:45 p.m. CDT

Veliparib

• Phase 1/2 Study of Veliparib (V) Combined with Carboplatin (Cb) and Etoposide (E) in Patients (Pts) with Extensive-Stage Disease (ED) Small Cell Lung Cancer (SCLC) and Other Solid Tumors: Phase 1 Results; Atrafi et al.; Abstract 8530; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
• Tolerability of Veliparib (V) in Combination with Carboplatin (C)/Paclitaxel (P): Based Chemoradiotherapy (CRT) in Subjects with Stage III Non-Small Cell Lung Cancer (NSCLC); Kozono et al.; Abstract 8546; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
• Breast Conservation after Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results from an International Randomized Trial (BrighTNess); Golshan et al.; Abstract 514; Poster Discussion Presentation; Sunday, June 4, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
• Phase 3 Study Evaluating Efficacy and Safety of Veliparib (V) Plus Carboplatin (Cb) or Cb in Combination with Standard Neoadjuvant Chemotherapy (NAC) in Patients (Pts) with Early Stage Triple-Negative Breast Cancer (TNBC); Geyer et al.; Abstract 520; Poster Discussion Presentation; Sunday, June 4, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT

Elotuzumab

• Phase 3 ELOQUENT-2 Study: Extended Four Year Follow-Up (FU) of Elotuzumab Plus Lenalidomide/Dexamethasone (ELd) vs Ld in Relapsed/Refractory Multiple Myeloma (RRMM); Lonial et al.; Abstract 8028; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
• CheckMate 602: An Open-Label, Randomized, Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma; Lonial et al.; Abstract TPS8052; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT

ABBV-221

• Preliminary Results from a Phase 1 Study of the Antibody-Drug Conjugate ABBV-221 in Patients with Solid Tumors Likely to Express EGFR; Calvo et al.; Abstract 2510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT

ABBV-399

• Phase I Study of ABBV-399, a c-Met Antibody-Drug Conjugate (ADC), as Monotherapy and in Combination with Erlotinib in Patients (Pts) with Non-Small Cell Lung Cancer (NSCLC); Angevin et al.; Abstract 2509; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
• Impact of MET Inhibitors on Survival Among Patients (Pts) with MET Exon 14 Mutant (METdel14) Non-Small Cell Lung Cancer (NSCLC); Awad et al.; Abstract 8511; Clinical Science Symposium; Sunday, June 4, 2017; 8:00 a.m.-9:30 a.m. CDT

ABT-348

• Pharmaco-kinetics/dynamics (PK/PD) Evaluation and Individual Patient Cross-Over Studies with Growth Trajectory Assessment to Adaptively Develop Ilorasertib; Maitland et al.; Abstract 2563; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT

The ASCO 2017 Annual Meeting abstracts are available at http://am.asco.org/abstracts.

About IMBRUVICA^® (ibrutinib) 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.^5,6 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.⁵

IMBRUVICA is FDA-approved in five distinct patient populations: CLL, SLL, WM, along with previously-treated MCL and MZL.

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

Accelerated approval was granted for the MCL and MZL indication based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.⁵

IMBRUVICA was one of the first medicines to receive U.S. Food and Drug Administration (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 and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry with nearly 30 company-sponsored trials underway, 14 of which are in Phase 3. In addition, there are approximately 100 investigator-sponsored trials and external collaborations that are ongoing and active around the world. To date, more than 65,000 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 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) and Pneumocystis jirovecii pneumonia (PJP) 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, 13% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, 0% to 13%) 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 (eg, 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, 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 (eg, 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

The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia* (61%), thrombocytopenia* (62%), diarrhea (43%), anemia* (41%), musculoskeletal pain (30%), rash (30%), nausea (29%), bruising (30%), fatigue (29%), hemorrhage (22%), 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%). The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MZL patients were pneumonia (10%), fatigue (6%), diarrhea (5%), rash (5%), and hypertension (5%).

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. Most common adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash, and neutropenia (1% each) in CLL/SLL patients and subdural hematoma (1.8%) in MCL patients. The most common adverse reactions leading to discontinuation were interstitial lung disease, diarrhea, and rash (1.6% each) in WM and MZL patients.

DRUG INTERACTIONS

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.

SPECIFIC POPULATIONS

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: https://www.imbruvica.com/prescribing-information.

About VENCLEXTA™ (venetoclax) in the U.S.
Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor developed by AbbVie and Genentech, a member of the Roche Group, indicated in the U.S. for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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.

Venclexta targets a specific protein in the body called BCL-2. 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. Through apoptosis, your body allows cancer cells and normal cells to self-destruct.

AbbVie and Genentech are committed to BCL-2 research with venetoclax, 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.

Venetoclax is under evaluation by health authorities in multiple countries, and is currently approved in more than 10 nations, including the U.S.

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.

VENCLEXTA™ (venetoclax) U.S. Use and Important Safety Information
Use
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.

• 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. If you are not sure about the type of immunization or vaccine, ask your doctor. 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 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 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.

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.⁷

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: 

• have an infection
• are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID may cause birth defects or death of an unborn baby.
  • Before receiving EMPLICITI with REVLIMID and dexamethasone, females and males must agree to the instructions in the REVLIMID REMS^® program. This program has specific requirements about birth control (contraception), pregnancy testing, blood donation, and sperm donation that you need to know. Talk to your healthcare provider to learn more about REVLIMID.
• are breastfeeding or plan to breastfeed. It is not known if EMPLICITI passes into breast milk. You should not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone. 
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Serious side effects that can occur with EMPLICITI treatment are:

Infusion reactions

• Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction.
• If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely.
• Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, trouble breathing, dizziness, light-headedness.

Infections

• Those receiving EMPLICITI with REVLIMID and dexamethasone may develop infections; some can be serious.
• Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including: fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash.

Risk of new cancers (malignancies)

• Those receiving EMPLICITI with REVLIMID and dexamethasone have a risk of developing new cancers.
• Talk with your healthcare provider about your risk of developing new cancers if you receive EMPLICITI.
• Your healthcare provider will check you for new cancers during your treatment with EMPLICITI.

Liver problems

• EMPLICITI may cause liver problems. Your healthcare provider will do blood tests to check your liver during treatment with EMPLICITI.
• Tell your healthcare provider if you have signs and symptoms of liver problems, including: tiredness, weakness, loss of appetite, yellowing of your skin or eyes, color changes in your stools, confusion, or swelling of the stomach area.

The most common side effects of EMPLICITI include: 

These are not all of the possible side effects of EMPLICITI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read Patient Information in the full Prescribing Information.

About Depatuxizumab Mafodotin
Depatuxizumab mafodotin, previously known as ABT-414, is an investigational antibody-drug-conjugate (ADC) being developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics.⁸ Depatuxizumab mafodotin is a biomarker-driven therapy that binds to an epitope that is exposed on tumor cells with epidermal growth factor receptor (EGFR) amplification and delivers a potent cytotoxin, a substance toxic to cells, that is released inside the tumor cell. It is being evaluated for EGFR-amplified newly diagnosed or recurrent glioblastoma (GBM), an aggressive malignant brain tumor.⁹

In 2014, the U.S. Food and Drug Administration (FDA) and the European Commission (EC) granted depatuxizumab mafodotin Orphan Drug Designation (ODD) for the treatment of GBM and glioma in adults, respectively.^10,11 In 2016, the FDA granted depatuxizumab mafodotin Rare Pediatric Disease Designation for the treatment of diffuse intrinsic pontine glioma (DIPG), a type of pediatric brain tumor.¹² Depatuxizumab mafodotin is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

About Rovalpituzumab Tesirine (Rova-T)
Rovalpituzumab tesirine (Rova-T) is an investigational antibody-drug conjugate (ADC) targeting delta-like protein 3 (DLL3), which is expressed in about 80 percent of small cell lung cancer (SCLC) patient tumors. It is prevalent on SCLC tumor cells, but not present in healthy tissue.¹³ Rova-T combines a targeted antibody with a cytotoxic agent to deliver a substance toxic to cells directly to the DLL3-expressing cancer cells. Rova-T is under investigation for the treatment of SCLC. An open-label, single-arm Phase 2 trial is under way to evaluate Rova-T in the third-line setting in relapsed or refractory DLL3-expressing SCLC.¹⁴ Two randomized Phase 3 trials have been initiated in the second-line and first-line maintenance setting. Additional studies are underway in multiple neuroendocrine tumor types, metastatic melanoma, and glioblastoma (GBM).¹⁵

Rova-T is an investigational compound and its efficacy and safety have not been established by the U.S. Food and Drug Administration (FDA) or any other health authority.

About Veliparib
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types.^16,17 PARP is a naturally-occurring enzyme in the body that repairs damage to DNA in cells. While this repair is a useful process to maintain the integrity of healthy cells, the same process may also help repair DNA in cancer cells, causing them to survive.¹⁸

Discovered and developed by AbbVie researchers, veliparib is being studied in combination with chemotherapy or radiation to help determine whether it can improve the survival outcome of common DNA-damaging therapies, such as chemotherapy or radiation, compared to platinum chemotherapy regimens alone.¹⁶ Veliparib is currently being studied in more than a dozen cancers, including in Phase 3 studies in advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), ovarian cancer and BRCA1/2 breast cancer.¹⁹ Veliparib is an investigational medicine and its efficacy and safety have not been established by the U.S. Food and Drug Administration (FDA) or any other health authority.

About ABBV-221, ABBV-399 and ABT-348
ABBV-221 is an investigational epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC) being studied in an open-label, dose escalation Phase 1 clinical trial for the treatment of EGFR-expressing solid tumors in participants with advanced solid tumors likely to exhibit elevated levels of EGFR.²⁰ ABBV-399 is an investigational c-Met targeted ADC being studied in an open-label Phase 1 clinical trial evaluating its safety, pharmacokinetics (PK) and preliminary efficacy in patients with solid tumors.^21,22 ABT-348 is an investigational novel kinase inhibitor targeting the aurora, vascular endothelial growth factor receptor/platelet-derived growth factor receptor, and Src kinase families and is being studied in a Phase 2 clinical trial of patients with CDKN2A deficient solid tumors.^23,24 These are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration (FDA) or any other health authority.

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 may 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 Stemcentrx in 2016, and through several collaborations, AbbVie's oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly 200 clinical trials in 20 different tumor types. For more information about AbbVie Oncology, please visit http://abbvieoncology.com.     

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.

About AbbVie
AbbVie is a global, research-driven 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 or LinkedIn.

AbbVie Forward-Looking Statements
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," of 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.

References

¹ Ostrom QT, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2009–2013. Neuro Oncol. 2016;18:v1-v75.
² Visser O, et al. Survival of adults with primary malignant brain tumours in Europe; Results of the EUROCARE-5 study. Eur J Cancer. 2015 [Epub ahead of print].
³ Brennan CW, et al. The somatic genomic landscape of glioblastoma. Cell. 2013;155:462-477.
⁴ Yoshimoto K, et al. Development of a real-time RT-PCR assay for detecting EGFRvIII in glioblastoma samples. Clin Cancer Res. 2008;14:488-493.
⁵ IMBRUVICA US Prescribing Information, January 2017.
⁶ Genetics Home Reference (2017). Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed March 2017.
⁷ Empliciti [Package Insert]. Princeton, N.J.: Bristol-Myers Squibb Company.
⁸ Van den Bent M, et al. ACTR-07. Efficacy of a novel antibody-drug conjugate (ADC), ABT-414, as monotherapy in epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM). Neuro Oncol. 2016; 18.
⁹ Omuro A, et al. Glioblastoma and other malignant gliomas: A clinical review. JAMA. 2013;310(17):1842-1850.
¹⁰ AbbVie Inc. ABT-414 Sponsor Briefing Document. Pediatric Oncology Subcommittee. November 19, 2015. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM472970.pdf. Accessed March 2017.
¹¹ 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 March 2017.
¹² Warren KE, et al. Diffuse intrinsic pontine glioma: poised for progress. Front Oncol. 2012;2:205.
¹³ Saunders LR, et al. A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumor-initiating cells in vivo. Sci Transl Med. 2015;7(302):1-13.
¹⁴ ClinicalTrials.gov (2017). NCT02674568: Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY). https://clinicaltrials.gov/ct2/show/NCT02674568?term=NCT02674568&rank=1. Accessed March 2017.
¹⁵ ClinicalTrials.gov (2017). Search Results: Rovalpituzumab Tesirine. https://clinicaltrials.gov/ct2/results?term=Rovalpituzumab+Tesirine+&Search=Search. Accessed March 2017.
¹⁶ Palma JP, et al. ABT-888 confers broad in vivo activity in combination with temozolomide in diverse tumors. Clin Cancer Res. 2009;15(23):7277-7290.
¹⁷ Anders CK, et al. Poly (ADP-Ribose) polymerase inhibition: "targeted" therapy for triple-negative breast cancer. Clin Cancer Res. 2010;16(19):4702-4710.
¹⁸ Plummer ER, et al. Targeting Poly (ADP-Ribose) Polymerase: A Two-Armed Strategy for Cancer Therapy. Clin Cancer Res. 2007;13(21): 6252-6256.
¹⁹ ClinicalTrials.gov (2017). Results: Veliparib: Open Studies. https://clinicaltrials.gov/ct2/results?term=veliparib&recr=Open. Accessed March 2017.
²⁰ Calvo, et al. Preliminary Results from a Phase 1 Study of the Antibody-Drug Conjugate ABBV-221 in Patients with Solid Tumors Likely to Express EGFR. Abstract 2510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT.
²¹ Angevin, et al. Phase I Study of ABBV-399, a c-Met Antibody-Drug Conjugate (ADC), as Monotherapy and in Combination with Erlotinib in Patients (Pts) with Non-Small Cell Lung Cancer (NSCLC). Abstract 2509; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT.
²² Awad, et al. Impact of MET Inhibitors on Survival Among Patients (Pts) with MET Exon 14 Mutant (METdel14) Non-Small Cell Lung Cancer (NSCLC). Abstract 8511; Clinical Science Symposium; Sunday, June 4, 2017; 8:00 a.m.-9:30 a.m. CDT.
²³ Maitland, et al. Pharmaco-kinetics/dynamics (PK/PD) Evaluation and Individual Patient Cross-Over Studies with Growth Trajectory Assessment to Adaptively Develop Ilorasertib. Abstract 2563; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT.
²⁴ ClinicalTrials.gov (2017). NCT02478320: Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors. https://clinicaltrials.gov/ct2/show/NCT02478320. Accessed May 2017.

SOURCE AbbVie