AbbVie, University of Chicago Extend Research Collaboration to Support Preclinical Oncology Research Through 2025

NORTH CHICAGO, Ill. and CHICAGO, Nov. 10, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) and the University of Chicago and have extended their collaboration agreement through 2025 to support preclinical oncology research.

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

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.

Clinical Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL) Published in The Lancet

NORTH CHICAGO, Ill., and COPENHAGEN, Denmark, Sept, 9, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Genmab A/S (Nasdaq: GMAB) today announced The Lancet published the results of the dose escalation part of the Phase 1/2 EPCORE™ NHL-1 first-in-human (FIH) dose escalation and cohort expansion clinical trial evaluating safety and preliminary efficacy of the investigational therapy epcoritamab (DuoBody®-CD3xCD20) in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL). The full manuscript is available on The Lancet's website. Epcoritamab is being co-developed by Genmab and AbbVie.

Venetoclax (VENCLEXTA®) Granted US FDA Breakthrough Therapy Designation (BTD) in Higher Risk Myelodysplastic Syndrome (MDS)

NORTH CHICAGO, Ill., July 21, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation (BTD) to venetoclax (VENCLEXTA®) in combination with azacitidine for the potential treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndromes (MDS) based on revised International Prognostic Scoring System (IPSS-R). A BTD is intended to expedite the development and review of medications to treat a serious medical condition and is granted when preliminary clinical evidence indicates the investigational therapy may demonstrate substantial improvement over existing therapies.1 This marks the sixth BTD granted to venetoclax.

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

NORTH CHICAGO, Ill., June 12, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data from the Phase 3 GLOW study comparing the efficacy and safety of the combination of IMBRUVICA® (ibrutinib) plus VENCLEXTA®/VENCLYXTO® (venetoclax) (I+V) versus chlorambucil plus obinutuzumab (C+O) for first-line treatment in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had active disease requiring treatment per the International Workshop on CLL (iwCLL) criteria. The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. I+V is the first all-oral, once-daily, chemotherapy-free, fixed-duration investigational combination. Results of the study will be presented at the European Hematology Association (EHA) 2021 Virtual Congress (Abstract #LB1902) during late-breaking abstract session on June 12 from 4:00-5:30 p.m. CEST.

New Data Shows AbbVie's VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

NORTH CHICAGO, Ill., June 11, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced results from a four-year follow-up analysis of the Phase 3 CLL14 trial, which showed that previously untreated patients with chronic lymphocytic leukemia (CLL) with coexisting conditions who were treated with VENCLYXTO®/VENCLEXTA® (venetoclax) plus obinutuzumab continued to show longer progression-free survival (PFS) and higher rates of undetectable minimal residual disease (MRD) compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil. The data were presented for the first time today during the virtual 26th European Hematology Association (EHA) Annual Congress (abstract #S146).

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

NORTH CHICAGO, Ill., June 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data from the Phase 2 CAPTIVATE (PCYC-1142) study investigating IMBRUVICA® (ibrutinib) in combination with VENCLEXTA®/VENCLYXTO® (venetoclax), an all-oral, once-daily, chemotherapy-free, fixed-duration investigational combination, for patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) during an oral presentation at the virtual 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #7501). The ibrutinib and venetoclax cohort met its primary endpoint of complete response (CR) rate of 56% (95% CI 48-64) among patients without del(17p), 70 years old or younger and with 27.9 months of follow up. This rate was higher than the 37% minimum meaningful rate study assumption (P<0.0001). The CR rate was consistent across all patients in the study including high-risk CLL patient groups. Furthermore, 24-month progression free survival (PFS) and overall survival (OS) were 95% and 98%, respectively. 

AbbVie Receives European Commission Approval of VENCLYXTO® (venetoclax) in Combination with a Hypomethylating Agent for Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

NORTH CHICAGO, Ill., May 25, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the European Commission (EC) has approved VENCLYXTO® (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.1 The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway.

AbbVie to Showcase Breadth of Oncology Portfolio and Pipeline at the 2021 ASCO and EHA Annual Congresses

NORTH CHICAGO, Ill., May 19, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) will present results from 43 abstracts across 12 types of cancer during the upcoming virtual American Society of Clinical Oncology (ASCO) Annual Meeting (June 4-8) and the virtual European Hematology Association (EHA) congress (June 9-17).

AbbVie Receives Positive CHMP Opinion for VENCLYXTO® (venetoclax) as a Combination Regimen for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

NORTH CHICAGO, Ill., April 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for VENCLYXTO® (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which is expected to deliver its final decision on VENCLYXTO combination therapy for use in AML in the first half of 2021.