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AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

Originally posted on Abbvie.com

– AbbVie will present more than 40 abstracts featuring data from approved and investigational medicines
– New minimal residual disease (MRD) data from CAPTIVATE clinical trial evaluating ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) in first-line treatment chronic lymphocytic leukemia (CLL) will be featured during the CLL Therapy Oral Session (abstract #35)
– Latest data from the ECOG-ACRIN Cancer Research Group-led Phase 3 E1912 study of ibrutinib in combination with rituximab, which served as the basis of a recent FDA sNDA submission, will be presented during the CLL Therapy Oral Session (Abstract #33)
– New long-term data from the MURANO trial evaluating continued benefit with fixed duration venetoclax plus rituximab in patients with relapsed/refractory (R/R) CLL will also be featured in the CLL Therapy Oral Session (abstract #355)

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that more than 40 abstracts, including 18 oral presentations, will be presented during the upcoming American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, in Orlando, FL. New data include presentations on Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) among others.

“At this year’s ASH Annual Meeting, AbbVie will showcase the latest scientific progress from our portfolio spanning various hematologic malignancies,” said Mohamed Zaki, M.D., Ph.D., Head of Hematology Oncology, AbbVie. “We look forward to sharing the new data from our clinical development programs for ibrutinib and venetoclax, which continue to demonstrate the potential to transform care and improve the lives of people living with various difficult-to-treat blood cancers.”

Data from two studies of ibrutinib combination regimens in the first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) will be featured in the CLL Therapy Oral Session. A new minimal residual disease (MRD)-guided analysis from the Phase 2 CAPTIVATE study (PCYC-1142) of ibrutinib in combination with venetoclax will be presented (Abstract #35), as well as longer-term outcomes data from the Phase 3 E1912 study of ibrutinib in combination with rituximab, which served as the basis of a recent U.S. Food and Drug Administration (FDA) sNDA submission (Abstract #33). In addition, extended follow-up data of up to 7.5 years in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) supporting the long-term disease control and tolerability with ibrutinib (Abstract #1538) and a four-year updated analysis from the Phase 3 MURANO trial of venetoclax in combination with rituximab will be shared (Abstract #355).

These new data will provide insights on the ongoing evaluation of ibrutinib (IMBRUVICA®) and venetoclax (VENCLEXTA/VENCLYXTO®) use among a variety of CLL patients.

Details about presentations are as follows:

Abstract

Presentation Timing

Ibrutinib

Ibrutinib Plus Venetoclax for First-line Treatment of
CLL/SLL: Results from the MRD Cohort of Phase 2
CAPTIVATE Study (PCYC-1142); Tam et al.;
Abstract #35

Saturday, December 7

Oral Session: 7:30 a.m. – 9:00 a.m. ET

Oral Presentation: 8:30 a.m. ET

Ibrutinib and Rituximab Compared to FCR in
Younger Patients with CLL: Extended Follow-Up
from the E1912 Trial; Shanafelt et al.; Abstract #33*

Saturday, December 7

Oral Session: 7:30 a.m. – 9:00 a.m. ET

Oral Presentation: 8:00 a.m. ET

Long-Term Outcomes with Ibrutinib Versus the Prior
Regimen: A Pooled Analysis in Relapsed/Refractory
MCL with up to 7.5 Years of Extended Follow-up
(MCL2001, MCL3001, CAN3001, PCYC-1104); Rule
et al.; Abstract #1538

Saturday, December 7

Poster Session: 5:30 p.m. – 7:30 p.m. ET

Planned Analysis of the Phase 1/2 CIRLL Trial for
CLL and MCL of Cirmtuzumab in Combination with
Ibrutinib; Choi et al.; Abstract #1755

Saturday, December 7

Poster Session: 5:30 p.m. – 7:30 p.m. ET

Clinical Impact of Ibrutinib with R-CHOP in Untreated
Non-GCB DLBCL Co-Expressing BCL2 and MYC
Genes in the Phase 3 PHOENIX Trial; Johnson et al.;
Abstract #354**

Sunday, December 8

Oral Session: 7:30 a.m. – 9:00 a.m. ET

Oral Presentation: 8:45 a.m. ET

Using Ibrutinib in Earlier Lines of Treatment in
CLL/SLL (RESONATE/RESONATE-2); Barr et al.;
Abstract #3054

Sunday, December 8

Poster Session: 6:00 p.m. – 8:00 p.m. ET

Phase 2 Results of the iR2 Regimen (Ibrutinib,
Lenalidomide, and Rituximab) in Patients with
Relapsed/Refractory Non-germinal Center B Cell–
Like (Non-GCB) Diffuse Large B-Cell Lymphoma
(DLBCL) (PCYC-1123); Ramchandren et al.;
Abstract #761

Monday, December 9

Oral Session: 2:45 p.m. – 4:15 p.m. ET

Oral Presentation: 3:45 p.m. ET

Venetoclax

Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line
Treatment of Chronic Lymphocytic Leukemia
(CLL)/Small Lymphocytic Lymphoma (SLL): Results
from the MRD Cohort of the Phase 2 CAPTIVATE
Study

Saturday, December 7

Oral Session: 7:30 a.m. – 9:00 a.m. ET

Oral Presentation: 8:30 a.m. ET

Quantitative Analysis of Minimal Residual Disease
(MRD) Shows High Rates of Undetectable MRD
After Fixed-Duration Chemotherapy-Free Treatment
and Serves as Surrogate Marker for Progression-
Free Survival: A Prospective Analysis of the
Randomized CLL14 trial

Saturday, December 7

Oral Session: 7:30 a.m. – 9:00 a.m. ET

Oral Presentation: 8:45 a.m. ET

T(11;14) and High BCL2 Expression are Predictive
Biomarkers of Response to Venetoclax in
Combination with Bortezomib and Dexamethasone
in Patients with Relapsed/Refractory Multiple
Myeloma: Biomarker Analyses from the Phase 3
BELLINI Study

Saturday, December 7

Oral Session: 9:30 a.m. – 11:00 a.m. ET

Oral Presentation: 10:15 a.m. ET

Identification of Recurrent Genomic Alterations in the
Apoptotic Machinery in CLL Patients Treated with
Venetoclax Monotherapy

Saturday, December 7

Oral Session: 12:00 p.m. – 1:30 p.m. ET

Oral Presentation: 12:45 p.m. ET

Updated Results from the Venetoclax (Ven) in
Combination with Idasanutlin (Idasa) Arm of a Phase
1b Trial in Elderly Patients (Pts) with Relapsed or
Refractory (R/R) Acute Myeloid Leukemia (AML)
Ineligible for Cytotoxic Chemotherapy

Saturday, December 7

Oral Session: 2:00 p.m. – 3:30 p.m. ET

Oral Presentation: 2:00 p.m. ET

Outcomes After Stem Cell Transplant in Older
Patients with Acute Myeloid Leukemia Treated with
Venetoclax-Based Therapies

Saturday, December 7

Oral Session: 2:00 p.m. – 3:30 p.m. ET

Oral Presentation: 3:15 p.m. ET

Safety and Efficacy of Venetoclax in Combination
with Navitoclax in Adult and Pediatric
Relapsed/Refractory Acute Lymphoblastic Leukemia
and Lymphoblastic Lymphoma

Saturday, December 7

Oral Session: 4:00 p.m. – 5:30 p.m. ET

Oral Presentation: 4:30 p.m. ET

Four-Year Analysis of MURANO Study Confirms
Sustained Benefit of Time-Limited Venetoclax-
Rituximab (VenR) in Relapsed/Refractory (R/R)
Chronic Lymphocytic Leukemia (CLL)

Sunday, December 8

Oral Session: 7:30 a.m. – 9:00 a.m. ET

Oral Presentation: 7:30 a.m. ET

Genome and Exome-Wide Studies Reveal Potential
Predictive Efficacy Markers for Venetoclax and
Rituximab (VenR) in Relapsed/Refractory Chronic
Lymphocytic Leukemia (R/R CLL): Subgroup
Analyses of the MURANO Trial

Sunday, December 8

Oral Session: 7:30 a.m. – 9:00 a.m. ET

Oral Presentation: 7:45 a.m. ET

A Phase 1b Study Evaluating the Safety and Efficacy
of Venetoclax as Monotherapy or in Combination
with Azacitidine for the Treatment of
Relapsed/Refractory Myelodysplastic Syndrome

Monday, December 9

Oral Session: 7:00 a.m. – 8:30 a.m. ET

Oral Presentation: 7:00 a.m. ET

A Phase 1b Study Evaluating the Safety and Efficacy
of Venetoclax in Combination with Azacitidine in
Treatment-Naïve Patients with Higher-Risk
Myelodysplastic Syndrome

Monday, December 9

Oral Session: 7:00 a.m. – 8:30 a.m. ET

Oral Presentation: 7:45 a.m. ET

Biomarker Modulation by Mivebresib (ABBV-075) +/–
Venetoclax in Relapsed/Refractory Acute Myeloid
Leukemia

Monday, December 9

Oral Session: 7:00 a.m. – 8:30 a.m. ET

Oral Presentation: 8:00 a.m. ET

Response to Venetoclax in Combination with Low
Intensity Therapy (LDAC or HMA) in Untreated
Patients with Acute Myeloid Leukemia Patients with
IDH, FLT3 and Other Mutations and Correlations
with BCL2 Family Expression

Monday, December 9

Oral Session: 7:00 a.m. – 8:30 a.m. ET

Oral Presentation: 8:15 a.m. ET

First Analysis from a Phase 1/2 Study of Venetoclax
in Combination with Daratumumab and
Dexamethasone, +/- Bortezomib, in Patients with
Relapsed/Refractory Multiple Myeloma

Monday, December 9

Oral Session: 6:15 p.m. – 7:45 p.m. ET

Oral Presentation: 6:15 p.m. ET

Phase 1/2 Study Evaluating the Safety and Efficacy
of Venetoclax in Combination with Dexamethasone
as Targeted Therapy for Patients with t(11;14)
Relapsed/Refractory Multiple Myeloma

Monday, December 9

Oral Session: 6:15 p.m. – 7:45 p.m. ET

Oral Presentation: 6:30 p.m. ET

Navitoclax

Results from a Phase 2 Study of Navitoclax in
Combination with Ruxolitinib in Patients with Primary
or Secondary Myelofibrosis

Monday, December 9

Oral Session: 10:30 a.m. – 12:00 p.m. ET

Oral Presentation: 11:30 a.m. ET

*Abstract was submitted by the National Cancer Institute

**Abstract was submitted by IMBRUVICA co-development partner, Janssen Biotech, Inc.

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