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MURANO: Final analysis and substudy results of VenR in R/R CLL
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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.
- Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378:1107-1120. DOI: 10.1056/NEJMoa1713976
- Kater AP, Harrup RA, Kipps TJ, et al. The MURANO study: final analysis and retreatment/crossover substudy results of VenR for patients with relapsed/refractory CLL. Blood. 2025. Online ahead of print. DOI: 10.1182/blood.2024025525
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