AbbVie Announces Results from Phase 3 VERONA Trial for Treating High-Risk Myelodysplastic Syndromes

AbbVie Releases Phase 3 VERONA Trial Findings

On June 16, 2025, AbbVie (NYSE: ABBV) shared the results of its Phase 3 VERONA trial, which investigated the combination of venetoclax and azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). The central finding revealed that the trial did not meet its primary endpoint of overall survival (OS), exhibiting a hazard ratio of 0.908, with a p-value of 0.3772. This data suggests that the combination therapy did not significantly extend the lives of patients compared to expected outcomes in this high-risk population.

Despite not achieving the primary goal, AbbVie confirmed that no new safety concerns arose during the trial progression. The full results and insights from the VERONA trial are anticipated to be presented at an upcoming medical congress or in a medical publication, providing further clarity on the efficacy and safety of the treatment regimen. Health professionals treating patients who participated in the trial will convey pertinent information regarding their treatment experiences with venetoclax in combination with azacitidine.

Overview of the VERONA Trial

The VERONA trial is a global randomized control study focusing on newly diagnosed HR-MDS patients. It compares the effectiveness and safety of venetoclax combined with azacitidine against azacitidine alone and a placebo. Overall survival serves as the primary outcome measure, while other key secondary endpoints include modified overall response rate (mOR) and complete remission (CR).

Venetoclax functions as a selective inhibitor of the B-cell lymphoma 2 (BCL-2) protein, a molecule often implicated in the survival of cancer cells. By targeting BCL-2, venetoclax facilitates the natural cell death process known as apoptosis, which is frequently compromised in various malignancies. Its approval has been established in over 80 countries, including the United States.

Current Indications and Important Information on VENCLEXTA®/VENCLYXTO®

VENCLEXTA (venetoclax) is currently indicated for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Additionally, it is approved for use alongside azacitidine, decitabine, or low-dose cytarabine to treat patients aged 75 and older or those who have medical conditions that prevent standard chemotherapy. However, the safety profile of VENCLEXTA in pediatric patients has not yet been established.

Potentially severe side effects inclusive of Tumor Lysis Syndrome (TLS) highlight the importance of precise monitoring prior to and during treatment. TLS results from rapid cell breakdown, which can lead to severe complications such as kidney failure. Citizens are informed to maintain hydration regularly during treatment, drinking an adequate volume of fluids.

All patients should communicate any preexisting medical conditions or concurrent medications to their healthcare provider prior to commencing treatment with VENCLEXTA, given the potential for significant drug interactions or exacerbation of side effects.

AbbVie’s Ongoing Commitment to Oncology

AbbVie continues to pioneer advancements in oncology, focusing on redefining treatment pathways for patients facing challenging cancers. Their pipeline of investigational therapies expands across diverse cancer types targeting various biological mechanisms involved in cancer proliferation. By fostering collaboration with innovative partners, AbbVie endeavors to accelerate the development and distribution of potential breakthrough medications in the oncology space.

AbbVie remains vigilant in assessing clinical data to optimize treatment options for patients suffering from cancer, as demonstrated by their current focus on managing higher-risk myelodysplastic syndromes through promising clinical trials like VERONA. As new data becomes available, ongoing improvements in patient care are anticipated, ultimately enhancing survival outcomes in these high-risk populations.

For more comprehensive details regarding the trial, additional studies can be accessed at Clinical Trials.