All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.
The lym Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the lym Hub cannot guarantee the accuracy of translated content. The lym and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View lymphoma & CLL content recommended for you
ASH 2017 | Interim analysis of Phase III MURANO study shows improved outcomes with venetoclax plus rituximab in patients with CLL
The 59th Annual Meeting & Exposition of the American Society of Hematology (ASH) took place in Atlanta, GA, on December 9–12, 2017. On Tuesday 12th December, a late-breaking abstract session was held , with abstract #LBA-2 being presented during this session titled “Venetoclax Plus Rituximab Is Superior to Bendamustine Plus Rituximab in Patients with Relapsed/ Refractory Chronic Lymphocytic Leukemia - Results from Pre-Planned Interim Analysis of the Randomized Phase 3 Murano Study” by John F Seymour Peter MacCallum Centre and Royal Melbourne Hospital, Melbourne, Australia, and colleagues.
In a previous Phase Ib study, the combination of venetoclax and rituximab was found to be effective with acceptable safety results in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This data lead to evaluating this combination in a Phase III (MURANO) study to assess efficacy and safety compared with standard immunochemotherapy.
Study Highlights
- 389 eligible patients with R/R CLL were included in the study
- Patients were randomized to receive either venetoclax with rituximab (VR) (n = 194) or bendamustine with rituximab (BR) (n = 195)
- Median follow-up = 23.8 months (0.0–37.4)
- Investigator-assessed (INV-assessed) progression-free survival (PFS) was superior for VR vs BR (HR = 0.17, 95%, CI 0.11–0.25, P < 0.0001)
- Median PFS VR vs BR:
- not reached vs0 months
- INV-assessed overall response rate (ORR) for VR vs BR:
- 3% vs 67.7% (Δ=25.6%, 95% CI, 17.9–33.3%)
- Minimal residual disease negativity (MRD–) was higher with VR vs BR:
- 5% vs 23.1%; (Δ=60.4%, 95% CI, 52.3–68.6%)
- 2-year overall survival (OS) for VR vs BR:
- 9% vs 86.6%; (HR = 0.48, 95% CI, 0.25–0.90, P = 0.0186)
Safety
- Most frequent grade 3–4 adverse events (AEs) VR vs BR:
- Neutropenia 57.7% vs 38.8%
- Anemia 10.8% vs 13.8%
- Thrombocytopenia 5.7% vs 10.1%
Dr Seymour concluded that VR was superior to BR in prolonging PFS and also that this trend was consistent across the subgroup analyses. He also noted that “the secondary endpoints were in favor of venetoclax and rituximab in particular the MRD negativity rate that was maintained over time. Thus overall, venetoclax plus rituximab should be considered as a suitable standard of therapy option for patients with relapsed or refractory CLL.”
References