AbbVie Data at EHA Annual Congress Highlight Depth and Breadth of Transformative Blood Cancer Portfolio

NORTH CHICAGO, Ill., May 15, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from studies evaluating the BCL-2 inhibitor venetoclax (VENCLEXTA®/ VENCLYXTO®), among others, from clinical trials across multiple blood cancers at the 25th European Hematology Association (EHA) Annual Congress, being held virtually from June 11-14, 2020. These data will span the company's investigational and approved oncology portfolio medicines across chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), multiple myeloma (MM), myelodysplastic syndrome (MDS) and myelofibrosis (MF).

AbbVie Announces Positive Topline Results from Phase 3 Trial of VENCLEXTA® (venetoclax) in Combination with Azacitidine in Patients with Acute Myeloid Leukemia (AML)

NORTH CHICAGO, Ill., March 23, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the VIALE-A (M15-656) trial of VENCLEXTA® (venetoclax) in combination with azacitidine versus azacitidine in combination with placebo met its dual primary endpoints of statistically significant improvement of overall survival (OS) and composite complete remission rate (CR + CRi) for patients with previously-untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. At the recommendation of an independent data monitoring committee (IDMC), and per the prespecified interim analysis plan, due to positive efficacy results at the first interim analysis for overall survival, the trial results will be reported early, and the data from the trial will be submitted to the U.S. FDA and global health authorities. Results will be presented at a future medical meeting or published in a peer-reviewed journal.

AbbVie Receives European Commission Approval of VENCLYXTO® Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia

NORTH CHICAGO, Ill., March 12, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that the European Commission (EC) has approved VENCLYXTO® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who were previously untreated. The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, Norway and the United Kingdom.

AbbVie Provides Update from Phase 3 Study Evaluating VENCLEXTA® (venetoclax) in Combination with Low-Dose Cytarabine in Newly-Diagnosed Patients with Acute Myeloid Leukemia (AML)

NORTH CHICAGO, Ill., Feb. 28, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the VIALE-C (M16-043) trial of venetoclax (VENCLEXTA®) in combination with low-dose cytarabine (LDAC) versus LDAC in combination with placebo did not meet its primary endpoint of statistically significant improvement of overall survival (OS) for patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy at the time of the planned analysis.3

New Long-Term Data Continues to Demonstrate Progression-Free Survival and Overall Survival Benefits with VENCLEXTA®/ VENCLYXTO® (venetoclax) Combination in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

NORTH CHICAGO, Ill., Dec. 8, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today presented long-term data from a post-hoc analysis, further supporting the sustained clinical benefit of fixed duration treatment with VENCLEXTA®/VENCLYXTO® (venetoclax) in combination with rituximab (VenR) in patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL). The updated data from the Phase 3 MURANO trial four-year analysis (median follow-up of 48 months with all patients off VENCLEXTA/VENCLYXTO treatment for a median of 22 months) showed that patients with R/R CLL who completed the chemotherapy-free, two-year fixed duration course of VENCLEXTA/VENCLYXTO treatment combination maintained progression-free survival (PFS) and overall survival (OS). Patients who completed treatment with the VENCLEXTA/VENCLYXTO combination also achieved higher rates of minimal residual disease (MRD)-negativity and complete remissions compared to those treated with a standard of care, bendamustine plus rituximab (BR).1 The full results were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition (abstract #355).

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

NORTH CHICAGO, Ill., Nov. 21, 2019 /PRNewswire/ -- 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.

AbbVie Discontinues Rovalpituzumab Tesirine (Rova-T) Research and Development Program

NORTH CHICAGO, Ill., Aug. 29, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research based global biopharmaceutical company, today announced that MERU, a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with placebo. The overall safety profile was generally consistent with that observed in previous studies. The MERU trial is being closed, and the Rova-T research and development program has been terminated. AbbVie will move forward prioritizing other development programs within its oncology pipeline.

One doctor’s journey with multiple myeloma

AbbVie’s global head of hematology development dives into the complexities of a blood cancer.

AbbVie Announces US FDA Lifts Partial Clinical Hold on Phase 3 Study of Venetoclax in Patients with Multiple Myeloma Positive for the t(11;14) Genetic Abnormality

NORTH CHICAGO, Ill., June 24, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on CANOVA (M13-494), a Phase 3 trial evaluating venetoclax (VENCLEXTA® OR VENCLYXTO®) for the investigational treatment of relapsed/refractory multiple myeloma. The CANOVA trial evaluates venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma positive for the translocation (11;14) abnormality. The t(11;14) genetic biomarker is among the most common and routinely tested genetic abnormalities in patients with multiple myeloma.1

AbbVie Presents Data from Venetoclax Chemotherapy-Free Combination Regimen for Patients with Previously Untreated Chronic Lymphocytic Leukemia

Phase 3 data from CLL14 study were highlighted in an oral presentation (abstract #7502) today at ASCO and published in the New England Journal of Medicine