Effectiveness of the Venetoclax/Rituximab Combination in the Treatment of CLL – 5-Year Follow-Up Data
At the virtual 62nd Annual Meeting of the American Society of Hematology (ASH), updated results of a clinical evaluation of the treatment of patients with refractory/relapsed chronic lymphocytic leukemia (R/R CLL) using venetoclax in combination with rituximab were presented.
Clinical Study MURANO
MURANO was a randomized phase III clinical study that compared the treatment of R/R CLL patients using a venetoclax/rituximab (VenR) combination with a bendamustine/rituximab (BR) combination. Achieving a deep response with undetectable minimal residual disease (MRD) was associated with longer progression-free survival (PFS) at 2-year follow-up for patients treated with VenR compared to BR. Now, 5-year follow-up results are available for study participants.
Methodology and Course
A total of 389 patients were randomized in a 1:1 ratio to treatment with either the VenR regimen (venetoclax 400 mg daily for 24 months) or BR (bendamustine at a dose of 70 mg/m2). All patients received rituximab at a standard dose for the first 6 months of treatment.
MRD in peripheral blood was determined using allele-specific polymerase chain reaction (PCR) and/or flow cytometry.
Results
The median follow-up duration was 59.2 months, the median PFS for VenR-treated patients was 53.6 months (95% confidence interval [CI] 48.4–57.0), patients treated with BR had a PFS of 17.0 months (95% CI 15.5–21.7). The 5-year overall survival (OS) rate for VenR therapy was 82.1% (95% CI 76.4–87.8) vs. 62.2% (95% CI 54.8–69.6) for BR treatment. No new safety signals were noted after 5 years of follow-up.
Undetectable MRD Improves OS
For patients treated with VenR who reached the end of therapy without disease progression and with undetectable MRD (n = 83/118), longer OS was observed compared to patients with measurable MRD (n = 35/118) – the estimated 3-year post-therapy survival rate was 95.3% vs. 85.0%.
32 patients from the undetectable MRD group maintained their response at the 5-year post-treatment check, while 47 patients experienced MRD conversion with a median time to conversion of 19.4 months (95% CI 8.7–28.3). Disease progression occurred in 19 of these patients, who exhibited a faster rise in MRD compared to patients who did not experience disease progression.
Conclusion
Data from 5 years after the start of the MURANO clinical study show sustainable benefits of the VenR combination for PFS and OS. Achieving undetectable MRD at the end of VenR therapy was associated with better OS in the VenR-treated cohort. A significant portion of patients who completed venetoclax therapy maintained a deep response to treatment even 36 months after its completion.
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Source: Kater A. P., Kipps T. J., Eichhorst B. et al. Five-year analysis of Murano study demonstrates enduring undetectable minimal residual disease (uMRD) in a subset of relapsed/refractory chronic lymphocytic leukemia (R/R CLL) patients (Pts) following fixed-duration venetoclax-rituximab (VenR) therapy (Tx). Abstract 125. 62nd ASH Annual Meeting and Exposition, 2020 Dec 5.
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