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MURANO: Final analysis and substudy results of VenR in R/R CLL

By Abhilasha Verma

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Apr 8, 2025

Learning objective: After reading this article, learners will be able to cite a new clinical development in chronic lymphocytic leukemia.



High-level expression of the antiapoptotic protein BCL2 is a key feature of CLL, making it an ideal therapeutic target.1 The phase III MURANO trial (NCT02005471) evaluated the efficacy of venetoclax-rituximab (VenR) vs bendamustine-rituximab (BR) in patients R/R CLL.1,2 Patients were randomly assigned to receive VenR (n = 194) or BR (n = 195).1 The primary endpoint was investigator-assessed PFS, with MRD status a key secondary endpoint.1 In the substudy, patients with PD received VenR as retreatment (n = 25) or crossover from BR (n = 9) and patient outcomes were analyzed based on patient’s genetic profiles.2 Results were published by Kater et al. in Blood.2


Key learnings
The mPFS was significantly higher for VenR vs BR at 54.7 months vs 17 months, respectively (p < 0.0001). The 7-year PFS rate was 23% for VenR, with no BR-treated patients remaining progression-free at this time.1
For VenR-treated patients with uMRD/no PD at EOT, the mPFS was 52.5 months, vs 18.0 months for those with MRD at EOT (p < 0.0001).1
The substudy results showed encouraging outcomes with VenR-retreated and VenR-crossover patients; mPFS was 23 months and 27 months, and best ORR was 72% and 89%, respectively.2
The results of the MURANO trial demonstrate long-term deep and durable efficacy for VenR. The data provide continued support for the treatment of R/R CLL with fixed-duration VenR, and suggest that VenR retreatment is a viable option.1

Abbreviations: BR, bendamustine-rituximab; CLL, chronic lymphocytic leukemia; EOT, end of treatment; mPFS, median progression-free survival; MRD, minimal residual disease; ORR, overall response rate; OS, overall survival; PD, progressive disease; R/R, relapsed/refractory; uMRD, undetectable MRD; VenR, venetoclax-rituximab.

References

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