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Statins May Improve Survival in Patients With Chronic Lymphocytic Leukemia Receiving Ibrutinib

Key Takeaways

  • Statin use significantly improves OS, PFS, and cancer-specific survival in CLL/SLL patients treated with ibrutinib.
  • The analysis included data from four randomized trials, adjusting for various patient and treatment factors.
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There was no significant increase in severe adverse events associated with statin use.

Statin therapies significantly improved overall survival (OS) and progression-free survival (PFS) in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma (SLL; CLL/SLL) treated with ibrutinib (Imbruvica; Janssen Biotech, AbbVie). The study findings were published in Blood Advances.1

Imbruvica, ibrutinib box | Image Credit: © CLShebley - stock.adobe.com

Imbruvica, ibrutinib box | Image Credit: © CLShebley - stock.adobe.com

CLL is an incurable but relatively manageable leukemia with a 5-year overall survival exceeding 90% with the emergence of modern treatments. It is a slow-growing leukemia characterized by the gradual accumulation of abnormal B cells in the blood, bone marrow, and lymph nodes, which eventually requires treatment. Statins have been shown to reduce mortality across cancer types, including CLL, but there is little evidence regarding their use in combination with targeted therapies such as ibrutinib. As a result, the investigators performed an analysis of data from 4 randomized trials: RESONATE (NCT01578707), RESONATE2 (NCT01722487), iLLUMINATE (NCT02264574), and HELIOS (NCT01611090).2-6

The primary outcomes measured included OS, PFS, and cancer-specific survival (CCS), and logistic regression models for greater than or equal to grade 3 adverse effects, as assessed using Cox proportional hazards models. The analyses were adjusted according to age, sex, weight, ECOG performance status, disease diagnosis, bulky disease (greater than or equal to 5 cm), time since initial diagnosis, comorbidity count, and the use of beta-blockers, calcium channel blockers, ACEIs/ARBs, and diuretics.1

The investigators assessed a total of 1467 patients, of whom 29% were using statins. The data showed that statin use was associated with substantial improvements in OS (adjusted HR[aHR] 0.55[0.42‑0.72], P < .001), PFS (aHR 0.73[0.61-0.88],P = .001), and CCS (aHR 0.39[0.22-0.70],P = .001), which were consistent across ibrutinib and non-ibrutinib treatment arms (OS P-interaction=0.52, PFS P-interaction=0.31) and CLL versus SLL diagnosis (OS P-interaction=0.77, PFS P-interaction=0.32).1

There was no discernible correlation between the usage of statins and grade≥3 side events. Regardless of the medication used, statin use was found to be an independent positive prognostic factor in patients with CLL/SLL.1

The findings are promising and may help inform therapeutic approaches that maximize survival in CLL/SLL. Further research is needed to validate the results and expand clinical understanding of the impact of statin therapy in the treatment of these patients.

REFERENCES
1. Abuhelwa A, Almansour S, Brown J. Statin use and survival in SLL/CLL treated with ibrutinib: Pooled analysis of four randomized controlled trials. Blood Adv. April 23, 2025. Doi:10.1182/bloodadvances.2024015287
2. Targeted therapies transform CLL care: Inside the era of BTK and BCL-2 inhibitors. Pharmacy Times. April 29, 2025. Accessed May 6, 2025. https://www.pharmacytimes.com/view/targeted-therapies-transform-cll-care-inside-the-era-of-btk-and-bcl-2-inhibitors
3. A phase 3 Study of ibrutinib (PCI-32765) versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (RESONATE™). Updated December 18, 2019. Accessed May 6, 2025. https://clinicaltrials.gov/study/NCT01578707
4. Open-label phase 3 BTK inhibitor ibrutinib vs chlorambucil patients 65 years or older with treatment-naive CLL or SLL. Updated November 30, 2017. Accessed May 6, 2025. https://clinicaltrials.gov/study/NCT01722487
5. A multi-center study of ibrutinib in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab in patients with treatment naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Updated September 21, 2020. Accessed May 6, 2025. https://clinicaltrials.gov/study/NCT02264574
6. A study of ibrutinib in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Updated March 3, 2020. Accessed May 6, 2025. https://clinicaltrials.gov/study/NCT01611090
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