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Fixed-Duration Venetoclax Regimens Offer CLL Patients a Balanced Approach

• Fixed-duration treatments in CLL offer a defined treatment period, contrasting with continuous therapies that require ongoing administration until disease progression or unacceptable toxicity. • Venetoclax-based regimens, such as venetoclax plus obinutuzumab for 12 cycles in the frontline setting, provide a time-limited treatment option. • In the relapsed/refractory setting, venetoclax combined with rituximab is approved for 24 cycles, offering another fixed-duration approach for CLL management.

Fixed-duration treatments are emerging as a valuable strategy in the management of chronic lymphocytic leukemia (CLL), offering patients a defined treatment period as opposed to continuous therapies that require ongoing administration. This approach aims to balance efficacy, quality of life, and cost considerations.

Fixed-Duration vs. Continuous Therapy

Unlike continuous therapies, which are administered until disease progression or unacceptable toxicity occurs, fixed-duration treatments involve a predetermined treatment duration. This can provide patients with a treatment-free interval, potentially reducing long-term side effects and improving overall quality of life.

Venetoclax-Based Regimens

Venetoclax, a BCL-2 inhibitor, has become a cornerstone of fixed-duration CLL treatment. In the frontline setting, venetoclax combined with obinutuzumab is approved for 12 cycles. This regimen offers a potent and time-limited approach for newly diagnosed CLL patients.
In the relapsed/refractory setting, venetoclax combined with rituximab is approved for 24 cycles. This fixed-duration regimen provides an effective option for patients whose CLL has returned or is no longer responding to initial treatments.
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Acalabrutinib Plus Venetoclax Significantly Improves PFS in Untreated CLL

The phase 3 AMPLIFY trial demonstrated that acalabrutinib plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival (PFS) in treatment-naive CLL patients.
The doublet and triplet regimens reduced the risk of disease progression or death by 35% and 58%, respectively, compared to chemoimmunotherapy.

Calquence Plus Venetoclax Shows Superior PFS in Untreated CLL

AstraZeneca's Calquence plus venetoclax demonstrated a statistically significant improvement in progression-free survival (PFS) compared to chemoimmunotherapy in untreated CLL patients.
The combination reduced the risk of disease progression or death by 35% compared to standard chemoimmunotherapy, with a 58% reduction when obinutuzumab was added.

Targeted Therapies Show Similar Safety Profiles in Relapsed/Refractory CLL

A network meta-analysis reveals that venetoclax plus rituximab, acalabrutinib, and zanubrutinib have comparable safety profiles in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL).
Bendamustine plus rituximab demonstrated a favorable safety profile, showing a lower risk of grade 3 or higher adverse events compared to other therapies.

Fixed-Duration Venetoclax Regimen Reduces Long-Term Costs in CLL Treatment

A real-world study shows that fixed-duration venetoclax-based treatment for chronic lymphocytic leukemia (CLL) results in lower long-term healthcare costs compared to continuous Bruton tyrosine kinase inhibitor (BTKi) therapy.
The venetoclax regimen was associated with an $8000 cost decrease six months after the fixed-duration period, primarily due to the absence of prescription drug costs.

Phase IIb/III Trial Assesses Tumor Lysis Syndrome Risk with Venetoclax Combinations in CLL

A Phase IIb/III study is evaluating the safety of venetoclax combined with obinutuzumab or acalabrutinib in chronic lymphocytic leukemia (CLL) patients.
The trial aims to optimize venetoclax dosing schemes and assess the risk of tumor lysis syndrome (TLS) in approximately 120 adult participants across 80 sites worldwide.

Ibrutinib/Venetoclax Shows Survival Benefit in High-Risk CLL/SLL

Fixed-duration ibrutinib plus venetoclax demonstrates meaningful survival benefits in high-risk CLL/SLL patients, with 5-year OS rates of 90% or greater.
The CAPTIVATE study showed a 5-year PFS rate of 67% in all treated patients and 54% in those with del(17p), TP53 mutations, or complex karyotype.

Intermittent Ibrutinib Dosing Shows Promise in Chronic Lymphocytic Leukemia

A phase 2 trial (IbruOnOff) evaluated response-based intermittent ibrutinib dosing in CLL patients who had previously achieved a complete or partial response on continuous ibrutinib.
The study found no new safety concerns with the intermittent dosing strategy, and a significant proportion of patients remained off treatment for extended periods.

Zanubrutinib, Obinutuzumab, and Venetoclax Triplet Achieves High uMRD Rates in CLL/SLL

A phase 2 trial (BOVen) showed that zanubrutinib plus obinutuzumab and venetoclax induced high rates of undetectable minimal residual disease (uMRD) in CLL/SLL patients.
92% of patients achieved uMRD in both peripheral blood and bone marrow, leading to treatment discontinuation after a median of 10 months.

Update on the Efficacy of Venetoclax for Chronic Lymphocytic Leukemia

Recent clinical trials have highlighted the efficacy of Venetoclax, both as a monotherapy and in combination with other treatments, for chronic lymphocytic leukemia (CLL). Studies show significant improvements in progression-free survival (PFS) and overall survival (OS) rates, especially in high-risk patient populations. The combination of Venetoclax with anti-CD20 monoclonal antibodies and Bruton’s tyrosine kinase inhibitors has shown promising results, offering deep and durable remissions. Additionally, measurable residual disease (MRD) assessments are becoming crucial in guiding treatment duration and cessation, with evidence supporting the re-initiation of Venetoclax therapy in relapsed patients.

Acalabrutinib, Venetoclax, and Obinutuzumab Show Durable Responses in CLL

Acalabrutinib, venetoclax, and obinutuzumab (AVO) triplet therapy demonstrates high activity and tolerability in frontline chronic lymphocytic leukemia (CLL) with a 93% progression-free survival rate.
The phase 2 trial showed an overall response rate of 98% across all patients, with 48% achieving complete remission and 50% achieving partial remission.

Reference News

[1]
Fixed-Duration vs Continuous CLL Therapy: Balancing Efficacy, Quality of Life, and Costs
curetoday.com · Sep 13, 2024

Fixed-duration treatments differ from continuous therapy in CLL. Venetoclax-based regimens are approved for 12 cycles wi...

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