NORTH CHICAGO, Ill., June 12, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new Phase 3 data on a fixed-duration venetoclax-based combination at the European Hematology Association (EHA) 2026 Congress taking place June 11-14 in Stockholm, Sweden. Final results from the Phase 3 CLL14 trial in previously untreated chronic lymphocytic leukemia (CLL), which was conducted in collaboration with the German CLL Study Group, will be featured in an oral presentation.
"The nine-year results from the landmark Phase 3 CLL14 trial affirm venetoclax's enduring safety and efficacy," said Daejin Abidoye, vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These data continue to add to the impressive body of evidence supporting the first-line use of venetoclax-based combination regimens in broader CLL patient populations, offering patients unprecedented time to next treatment — and therefore time off treatment — after one year of fixed-duration therapy. This research advances our mission to transform care and deliver better outcomes for patients living with difficult-to-cure blood cancers."
"Venetoclax in combination with obinutuzumab has shown positive responses across several key measures compared to obinutuzumab plus chlorambucil, including an extended increase in progression-free survival in previously untreated patients with chronic lymphocytic leukemia," said Kirsten Fischer, M.D., investigator in the CLL14 study, University Hospital Cologne. "Importantly, with a demonstrated median time to next treatment of approximately eight years, the findings reflect the sustained durability of this combination treatment option with a meaningful time without CLL specific treatment for patients."
A final analysis of the Phase 3 CLL14 trial, conducted in close collaboration with the German CLL Study Group, comparing venetoclax plus obinutuzumab to chlorambucil plus obinutuzumab in previously untreated patients with CLL and coexisting medical conditions, found that venetoclax plus obinutuzumab significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab, providing a limited-duration treatment option for unfit patients with previously untreated CLL. The nine-year analysis demonstrated the long-term off-treatment efficacy and safety of the venetoclax plus obinutuzumab fixed-duration combination, with the median time to next treatment (TTNT) of 7.6 years.1
After a median follow-up of 9.2 years, treatment with venetoclax plus obinutuzumab resulted in superior PFS compared to the obinutuzumab plus chlorambucil group, with median PFS of 6.4 years versus 3.2 years, respectively (HR 0.50 [95% CI 0.39-0.63], p<0.001). The most frequently occurring Grade 3 (≥2%) adverse events (AEs) in patients receiving the venetoclax-based combination were neutropenia, thrombocytopenia, infusion-related reaction, anemia, febrile neutropenia, pneumonia and leukopenia.1,2
CLL is one of the most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes).3 Patients with CLL often experience relapsed disease, meaning the cancer has returned after previously responding to treatment, while others experience refractory disease when the cancer stops responding to therapy.4 While outcomes have improved in recent years, patients can often face long treatment durations and ongoing disease management challenges.
About the CLL14 Phase 3 Trial2,5,6,7
The prospective, multicenter, open-label, randomized Phase 3 CLL14 trial (NCT02242942), which was conducted in close collaboration with the German CLL Study Group (GCLLSG), evaluated the efficacy and safety of a combined regimen of venetoclax and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in previously untreated patients with CLL and co-existing medical conditions (total Cumulative Illness Rating Scale [CIRS] score >6 or creatinine clearance <70 mL/min). The therapies were administered for a fixed duration of 12 months for venetoclax in combination with six cycles of obinutuzumab. The trial enrolled 432 patients, all of whom were previously untreated, according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Efficacy was based on PFS, as assessed by an independent review committee.
Key secondary endpoints were rates of MRD in peripheral blood and bone marrow and overall and complete response rates.
In patients with CLL receiving venetoclax combination therapy with obinutuzumab, the most frequently occurring Grade 3 (≥2%) adverse events (AEs) were neutropenia, thrombocytopenia, infusion-related reaction, anemia, febrile neutropenia, pneumonia and leukopenia.1,2
About VENCLYXTO
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. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.
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 and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.
VENCLYXTO (venetoclax) EU Indication and Summary of Important Safety Information
Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL):
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in combination with acalabrutinib with or without obinutuzumab
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in combination with obinutuzumab
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in combination with ibrutinib
VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
VENCLYXTO monotherapy is indicated for the treatment of CLL:
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In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
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In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio.
About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.
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Fischer K, Al-Sawaf O ,et al. Venetoclax-obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia: Final Results of the Randomized CLL14 Study. Abstract EHA-2488 presented at the European Hematology Association Congress 2026. Stockholm, Sweden.
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Fischer K, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380:2225-2236.
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American Cancer Society. Leukemia – Chronic Lymphocytic Leukemia. Available at: https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html. Accessed June 2026.
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Nastoupil L, Flowers C. Management of relapsed chronic lymphocytic leukemia: applying guidelines to practice. Community Oncol. 2012; 9(12): S85–S92. doi:10.1016/j.cmonc.2012.09.019.
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Clinicaltrials.gov. NCT02242942: A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax (GDC-0199/ABT-199) Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions. Accessed June 2026.
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Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.
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VENCLEXTA (venetoclax) [Package Insert]. North Chicago, Ill.: AbbVie Inc