AbbVie to Highlight New Advances in Blood Cancer Research and Expanding Oncology Pipeline at 63rd ASH Annual Meeting

Rhea-AI Summary

AbbVie (NYSE: ABBV) is set to present nearly 30 abstracts at the upcoming American Society of Hematology (ASH) Annual Meeting, scheduled for December 11-14 in Atlanta, Georgia. Key studies include the Phase 2 CAPTIVATE and Phase 3 GLOW trials, which assess treatments for chronic lymphocytic leukemia (CLL) using ibrutinib and venetoclax. Additional research will cover various hematologic cancers, focusing on venetoclax's efficacy in CLL and multiple myeloma. The findings aim to advance care standards for patients with significant unmet medical needs.

Positive

• Presentation of nearly 30 abstracts demonstrates AbbVie's commitment to oncology research.
• Highlights the efficacy of ibrutinib and venetoclax in treating CLL, potentially improving patient outcomes.
• Collaboration with Genmab and I-Mab on investigational therapies could enhance AbbVie's product pipeline.

Negative

• Venetoclax's use in multiple myeloma and myelodysplastic syndromes is not yet FDA approved, limiting market potential.
• Epcoritamab and lemzoparlimab remain investigational, indicating ongoing uncertainty in their commercial viability.

NORTH CHICAGO, Ill., Nov. 4, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) will present results from nearly 30 abstracts across eight types of cancer during the upcoming American Society of Hematology (ASH) Annual Meeting (December 11-14) in Atlanta, Georgia.

"We are dedicated to transforming standards of care for people living with blood cancers," said Mohamed Zaki, M.D., Ph.D, vice president and global head of oncology development, AbbVie. "The data we are presenting at the ASH Annual Meeting build on our deep expertise in the development of novel treatments that have the potential to make a remarkable difference for people living with blood cancers and other tumor types with significant unmet needs."

At ASH, AbbVie will present data from the Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating minimal residual disease and disease-free survival outcomes with fixed duration treatment in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) who received the ibrutinib (IMBRUVICA^®) + venetoclax (VENCLEXTA^®/ VENCLYXTO^®) combination regimen. In addition, AbbVie will present results from several studies, including: multiple abstracts evaluating venetoclax in approved indications – CLL, acute myeloid leukemia (AML) – and investigational indications – multiple myeloma (MM) and myelodysplastic syndromes (MDS); the updated results of ABBV-383 (an anti-BCMA x CD3 bispecific antibody); three abstracts on epcoritamab (an anti-CD20 x CD3 bispecific antibody) in partnership with Genmab; and an abstract on lemzoparlimab (an anti-CD47 antibody) in partnership with I-Mab.

Details about presentations are as follows:

ASH 2021 Abstracts
Abstract	Presentation Details All times in CT
Ibrutinib
First-Line Treatment with Ibrutinib (Ibr) Plus Venetoclax (Ven) for Chronic Lymphocytic Leukemia (CLL): 2-Year Post-Randomization Disease-Free Survival (DFS) Results From the Minimal Residual Disease (MRD) Cohort of the Phase 2 CAPTIVATE Study	Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Combination Small Molecules Saturday, December 11 8:45 a.m. CT Oral Presentation
First Prospective Data on Minimal Residual Disease (MRD) Outcomes After Fixed-Duration Ibrutinib Plus Venetoclax (Ibr+Ven) Versus Chlorambucil Plus Obinutuzumab (Clb+O) for First-Line Treatment of CLL in Elderly or Unfit Patients: The GLOW Study	Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Combination Small Molecules Saturday, December 11 9:15 a.m. CT Oral Presentation
Impact of Dosing Frequency of Oral Oncolytics on Refill Adherence Among Patients with Hematological Malignancies	Session: Outcomes Research—Lymphoid Malignancies: Poster I Saturday, December 11 4:30 – 6:30 p.m. CT Poster Presentation
Application of National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for CLL/SLL from the inform CLL Real-World Registry	Session: Outcomes Research—Lymphoid Malignancies: Poster I Saturday, December 11 4:30 – 6:30 p.m. CT Poster Presentation
Venetoclax
Final Overall Survival Results from BELLINI, a Phase 3 Study of Venetoclax or Placebo in Combination With Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma	Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Phase 2 and 3 Trials in Myeloma Saturday, December 11 9:45 a.m. CT Oral Presentation
Outcomes in Patients with Poor-risk Cytogenetics with or without TP53 Mutations Treated with Venetoclax Combined with Hypomethylating Agents	Session: Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Response Prediction across the Spectrum of DNA, RNA, Protein and Ex Vivo Cells Saturday, December 11 1:00 – 1:30 p.m. CT Oral Presentation
Molecular Responses are Observed Across Mutational Spectrum in Treatment-Naïve Higher-Risk Myelodysplastic Syndrome Patients Treated with Venetoclax plus Azacitidine	Session: Myelodysplastic Syndromes – Clinical and Epidemiological: Treatment of High-Risk Myelodysplastic Syndrome Saturday, December 11 1:00 – 1:30 p.m. CT Oral Presentation
Venetoclax in Combination with Gilteritinib Demonstrates Molecular Clearance of FLT3 Mutation in Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia	Session: Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Current approach to FLT3 mutated AML Monday, December 13 1:45 – 3:15 p.m. CT Oral Presentation
Venetoclax and Azacitidine in the Treatment of Patients with Relapsed/Refractory Myelodysplastic Syndrome	Session: Myelodysplastic Syndromes – Clinical and Epidemiological: Treatment of High Risk and Relapsed/Refractory Myelodysplastic Syndrome Sunday, December 12 3:30 – 5:00 p.m. CT Oral Presentation
Safety and Preliminary Efficacy From the Expansion Cohort of a Phase 1/2 Study of Venetoclax Plus Daratumumab and Dexamethasone vs Daratumumab Plus Bortezomib and Dexamethasone in Patients With t(11;14) Relapsed/Refractory Multiple Myeloma	Session: Dyscrasias: Clinical and Epidemiological: Challenges in Multiple Myeloma Therapy: Adopting New Approaches for Relapse and Monitor Monday, December 13 3:30 p.m. CT Oral Presentation
Real-World Management of Patients with Newly Diagnosed Acute Myeloid Leukemia Treated with Venetoclax-based Regimens: Results from the AML Real world evidenCe (ARC) Initiative	Session: Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I Saturday, December 11 4:30 – 6:30 p.m. CT Poster
Rapid and Sustained Reduction of Immunosuppressive T-cells and Focusing of the T-cell Repertoire in t(11;14) Relapsed/Refractory Multiple Myeloma Patients Treated with Venetoclax in Combination with Daratumumab and Dexamethasone	Session: Multiple Myeloma and Plasma cell Dyscrasias: Clinical and Epidemiological: Poster I Saturday, December 11 5:00 – 7:00 p.m. CT Poster
A Retrospective Analysis of Patients with Chronic Lymphocytic Leukemia (CLL) Treated with Venetoclax in the Real-life Setting in Spain (Venares)	Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I Saturday, December 11 5:00 – 7:00 p.m. CT Poster
Treatment Initiation of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Untreated Acute Myeloid Leukemia	Session: Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies Saturday, December 11 4:30 – 6:30 p.m. CT Poster
ReVenG: A Phase 2 Study of Venetoclax Plus Obinutuzumab Retreatment in Patients with Relapsed Chronic Lymphocytic Leukemia	Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II Sunday, December 12 5:00 – 7:00 p.m. CT Poster
Comparative Effectiveness of Venetoclax Combinations vs Other Therapies Among Patients with Newly Diagnosed Acute Myeloid Leukemia: Results from the AML Real World Evidence (ARC) Initiative	Session: Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II Sunday, December 12 5:00 – 7:00 p.m. CT Poster
Management and the Use of Healthcare Resources in Patients with Chronic Lymphocytic Leukemia (CLL) Initiating Venetoclax in Routine Clinical Practice (DEVOTE) Across Canada	Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Monday, December 13 5:00 – 7:00 p.m. CT Poster Presentation
P17-132 AbbVie PMOS VeRVe: Safety and Effectiveness of Venetoclax Therapy Subsequent to BCRi Therapy Under Real-world Conditions in Austria, Germany and Switzerland	Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Monday, December 13 5:00 – 7:00 p.m. CT Poster
Debulking Before Initiation of Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia: Results from a Phase 3b Study	Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Monday, December 13 5:00 – 7:00 p.m. CT Poster
Assessment of the Clonal Dynamics of Acquired Mutations in Patients (pts) with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) Treated in the Randomized Phase 3 MURANO Trial Supports Venetoclax+Rituximab (VenR) Fixed-Duration Combination Treatment (tx)	Session: 1548 - 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I Saturday, December 11 4:30 - 6:30 p.m. CT Poster
Chronic Lymphocytic Leukemia (CLL) Clonal Growth Rate is Influenced by Previous Treatment (Tx) and is Slowed Down Following Venetoclax-Rituximab (VenR): Results From a Minimal Residual Disease (MRD) Model From the Randomized Phase 3 MURANO Trial	Session: TBC Saturday, December 11 4:30 - 6:30 p.m. CT Poster
Chronic Lymphocytic Leukemia (CLL) Patients Quality of Life (QoL): A Cross-sectional Analysis of the Italian Experience in the CHOICE Study During the First Wave of the COVID-19 Pandemic	Abstract Publication Only
COVID-19 Pandemic Impact on Chronic Lymphocytic Leukemia (CLL) Patients' Preferences Towards Therapies: The Italian Experience (Choice Study).	Abstract Publication Only
Lab-Based Response Assessment Algorithm Recapitulates Investigator's Response Assessment in the Phase 3 Bellini Trial	Abstract Publication Only
Epcoritamab
Subcutaneous Epcoritamab in Combination with R-CHOP in Patients with Previously Untreated High-Risk Diffuse Large B-cell Lymphoma: Preliminary Results from a Phase 1/2 Trial	Session: Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I Saturday, December 11, 2021 4:30 – 6:30 p.m. CT Poster
Subcutaneous Epcoritamab in Combination with R2 (Rituximab and Lenalidomide) in Patients with Relapsed or Refractory Follicular Lymphoma: Preliminary Results from a Phase 1/2 Trial	Session: Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III Monday, December 13 5:00 – 7:00 p.m. CT Poster
Subcutaneous Epcoritamab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Preliminary Results from the EPCORE CLL-1 Trial	Session: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II Sunday, December 12 5:00 – 7:00 p.m. CT Poster
Lemzoparlimab
Lemzoparlimab, a Differentiated Anti-CD47 Antibody in Combination with Rituximab in Relapsed and Refractory Non-Hodgkin's Lymphoma: Initial Clinical Results	Session: Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III Monday, December 13, 2021 6:00 – 8:00 p.m. CT Poster
ABBV-383
A Phase 1 First-in-Human Study of TNB-383B (ABBV-383), a BCMA x CD3 Bispecific T-Cell Redirecting Antibody, in Patients with Relapsed/Refractory Multiple Myeloma	Session: Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Immune Therapy for Multiple Myeloma Monday, December 13 6:30 p.m. CT Oral

The ASH 2021 Annual Meeting abstracts are available at: https://www.hematology.org/meetings/annual-meeting/abstracts

*Use of venetoclax in multiple myeloma (MM) and myelodysplastic syndromes (MDS) is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

*Epcoritamab is investigational and being developed through Genmab and AbbVie as part of the companies' broad oncology collaboration.

**Lemzoparlimab is investigational and being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumor in collaboration with AbbVie and I-Mab.

About Ibrutinib (IMBRUVICA^®)
IMBRUVICA (ibrutinib) is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company, and Janssen Biotech, Inc. (Janssen). The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.^1,2 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.³

Since its launch in 2013, IMBRUVICA^® has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström macroglobulinemia; previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.⁴

IMBRUVICA^® is now approved in more 100 countries and has been used to treat more than 250,000 patients worldwide across its approved indications. IMBRUVICA^® has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA^® was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

Since 2019, the National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 31 leading cancer centers devoted to patient care, research, and education, has recommended ibrutinib (IMBRUVICA®) as a preferred regimen for first-line treatment of CLL/SLL, with Category 1 status for previously untreated patients without deletion 17p. Since January 2020, the NCCN Guidelines® have recommended IMBRUVICA® with or without rituximab as a preferred regimen for the treatment of relapsed/refractory MCL. Since September 2020, the NCCN guidelines have recommended IMBRUVICA® with or without rituximab as a Category 1 preferred regimen for both untreated and previously treated WM patients.

IMBRUVICA^® is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. There are more than 50 company sponsored clinical trials, including 18 ongoing or completed Phase 3 studies, over 11 years evaluating efficacy and safety of IMBRUVICA. For more information, visit www.IMBRUVICA.com.

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

Important Side Effect Information⁴

Before taking IMBRUVICA^®, tell your healthcare provider about all of your medical conditions, including if you:

• have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA^® for any planned medical, surgical, or dental procedure.
• have bleeding problems.
• have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
• have an infection.
• have liver problems.
• are pregnant or plan to become pregnant. IMBRUVICA^® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA^®. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA^®.
• Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA^® and for 1 month after the last dose.
• Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA^® and for 1 month after the last dose.
• are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA^® and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA^® with certain other medicines may affect how IMBRUVICA^® works and can cause side effects.

How should I take IMBRUVICA^®?

• Take IMBRUVICA^® exactly as your healthcare provider tells you to take it.
• Take IMBRUVICA^® 1 time a day.
• Swallow IMBRUVICA^® capsules or tablets whole with a glass of water.
• Do not open, break or chew IMBRUVICA^® capsules.
• Do not cut, crush or chew IMBRUVICA^® tablets.
• Take IMBRUVICA^® at about the same time each day.
• If you miss a dose of IMBRUVICA^® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA^® at your regular time on the next day. Do not take extra doses of IMBRUVICA^® to make up for a missed dose.
• If you take too much IMBRUVICA^® call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking IMBRUVICA^®?

• You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA^®. These products may increase the amount of IMBRUVICA^® in your blood.

What are the possible side effects of IMBRUVICA^®?
IMBRUVICA^® may cause serious side effects, including:

• Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA^®, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache.
• Infections can happen during treatment with IMBRUVICA^®. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA^®.
• Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA^®,but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
• Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation, and atrial flutter), heart failure, and death have happened in people treated with IMBRUVICA^®, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles, or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your IMBRUVICA^® dose.
• High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA^®. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
• Second primary cancers. New cancers have happened during treatment with IMBRUVICA^®, including cancers of the skin or other organs.
• Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

The most common side effects of IMBRUVICA^® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

• diarrhea
• tiredness
• muscle and bone pain
• rash
• bruising

The most common side effects of IMBRUVICA^® in adults with cGVHD include:

• tiredness
• bruising
• diarrhea
• mouth sores (stomatitis)
• muscle spasms
• nausea
• pneumonia

Diarrhea is a common side effect in people who take IMBRUVICA^®. Drink plenty of fluids during treatment with IMBRUVICA^® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.
These are not all the possible side effects of IMBRUVICA^®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of IMBRUVICA^®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA^® for a condition for which it was not prescribed. Do not give IMBRUVICA^® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA^® that is written for health professionals.

Please click here for full Prescribing Information.

 

About VENCLEXTA®/VENCLYXTO® (venetoclax)

VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood cancers. Venetoclax is approved in more than 80 countries, including the U.S. Venetoclax is being studied for new uses including mantle cell lymphoma, Myelodysplastic syndromes and a combination regimen of venetoclax + ibrutinib in chronic lymphocytic leukemia.

Indication and Important Safety Information for VENCLEXTA® (venetoclax) US⁵

Indication

VENCLEXTA is a BCL-2 inhibitor indicated:

• For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1)
• In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Important Safety Information⁵
What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS.

Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

• Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
• Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.

Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney 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 healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
• are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
• are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.

What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:

• Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
• Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.

Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. 

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA^® can be found here. 

Globally, prescribing information varies; refer to the individual country product label for complete information.

About Epcoritamab

Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.⁶ CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.^7,8 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' broad oncology collaboration.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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

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1 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed: November 2020.

2 Turetsky, et al. Single cell imaging of Bruton's Tyrosine Kinase using an irreversible inhibitor. Scientific Reports. volume 4, Article number: 4782 (2014)

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4 IMBRUVICA U.S. Prescribing Information.

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6 Engelbert et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020 Feb;52: 102625. doi: 10.1016/j.ebiom.2019.102625. Epub 2020 Jan 23. PMID: 31981978; PMCID: PMC6992935.

7 Rafiq, Sarwish, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties." Journal of Immunology (Baltimore, Md. 1950), U.S. National Library of Medicine, 15 Mar. 2013, www.ncbi.nlm.nih.gov/pmc/articles/PMC3631574/.

8 Singh, Vijay, et al. "Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." Journal of Cancer Science & Therapy, U.S. National Library of Medicine, Nov. 2015, www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/.

 

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SOURCE AbbVie

FAQ

What studies will AbbVie present at the ASH Annual Meeting?

AbbVie will present results from nearly 30 abstracts, focusing on treatments for chronic lymphocytic leukemia (CLL) and other hematologic cancers.

What are the key trials discussed in AbbVie's ASH presentations?

Key trials include the Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating the effectiveness of ibrutinib and venetoclax.

When is the ASH Annual Meeting taking place?

The ASH Annual Meeting is scheduled for December 11-14, 2021, in Atlanta, Georgia.

What is the significance of the data being presented by AbbVie?

The data aims to transform standards of care for patients with blood cancers and address significant unmet medical needs.

What collaborations are highlighted in AbbVie’s ASH presentation?

AbbVie collaborates with Genmab on the investigational therapy epcoritamab and with I-Mab on lemzoparlimab.