On June 12, 2026 AbbVie (NYSE: ABBV) reported new Phase 3 data on a fixed-duration venetoclax-based combination at the European Hematology Association (EHA) (Free EHA Whitepaper) 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.
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"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):
in combination with acalabrutinib with or without obinutuzumab
in combination with obinutuzumab
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:
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
In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase. Concomitant use of preparations containing St. John’s wort.
Special Warnings & Precautions for Use
Tumour lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients with CLL when treated with venetoclax. Venetoclax poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLYXTO and at each dose increase. During post marketing surveillance, TLS, including fatal events, has been reported after a single 20 mg dose of venetoclax. The risk of TLS is a continuum based on multiple factors, including comorbidities (particularly reduced renal function), tumour burden, and splenomegaly in CLL. Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS.
Neutropenia (grade 3 or 4) has been reported and complete blood counts should be monitored throughout the treatment period. Serious infections, including sepsis with fatal outcome, have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment and dose interruption or reduction, as appropriate. Live vaccines should not be administered during treatment or thereafter until B-cell recovery.
Drug Interactions
CYP3A inhibitors: For patients requiring concomitant use with venetoclax, refer to the SmPC for recommendations for managing drug-drug interactions. Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted. Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax.
Additional agents that may alter venetoclax plasma concentrations include P-gp or BCRP inhibitors, CYP3A inducers (including St. John’s wort), azithromycin and bile acid sequestrants. Concomitant use of these agents with venetoclax may require further dose adjustments and patients should be monitored closely for signs of toxicities.
Adverse Reactions
The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab, ibrutinib, or rituximab were diarrhoea, neutropenia, nausea, upper respiratory tract infection, fatigue and vomiting. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.
The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with obinutuzumab, ibrutinib, or rituximab were pneumonia, febrile neutropenia, sepsis, neutropenia, anaemia, diarrhoea and TLS. In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.
The most commonly occurring adverse reactions (≥20%) of any grade in patients treated with venetoclax in combination with acalabrutinib were infections, neutropenia, headache, bruising, diarrhoea and musculoskeletal pain. The most commonly reported Grade ≥3 adverse reaction (≥5%) was neutropenia.
The most commonly occurring adverse reactions of any grade (≥20%) in patients treated with venetoclax in combination with acalabrutinib and obinutuzumab were infections, neutropenia, headache, bruising, diarrhoea, nausea and musculoskeletal pain. The most commonly reported Grade ≥3 adverse reactions (≥5%) were neutropenia and thrombocytopenia.
Discontinuations, dosage reductions and dose interruptions due to adverse reactions have occurred in both venetoclax monotherapy and in combination therapy.
Special Populations
Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Venetoclax should be administered to patients with severe renal impairment (CrCl ≥15 ml/min and <30 ml/min) or end-stage renal disease (ESRD) requiring dialysis (CrCL <15ml/min) only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.
For patients with severe hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended. These patients should be monitored more closely for signs of toxicity.
Women should avoid becoming pregnant while taking venetoclax and for at least 30 days after ending treatment. Therefore, women of childbearing potential must use highly effective contraceptive measures while taking venetoclax and for 30 days after stopping treatment. Venetoclax may harm the foetus when administered to a pregnant woman. Breast-feeding should be discontinued during treatment with venetoclax.
(Press release, AbbVie, JUN 12, 2026, View Source [SID1234666611])