Leukemia combination therapy shows efficacy and effectively controls disease progression
November 23, 2017 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Venclexta (venetoclax), a drug developed by AbbVie and Roche, was approved in 2016 as a new treatment for chronic lymphocytic leukemia (CLL). A recent study found that venetoclax combined with rituximab was superior to standard therapy in the treatment of relapsed or refractory (R/R) CLL. This result will be announced at the American Society of Blood (ASH) 2017 conference.
Venetoclax is a potent and highly selective potent BCL-2 inhibitor that achieves a high overall response rate (ORR) when used as a monotherapy for R/R CLL. When venetoclax is used in combination with rituximab, it is well tolerated and has a good rate of complete remission (CR) and a negative residual disease (MRD-).
The efficacy of this drug was validated in the phase 3 clinical trial MURANO. The trial was a randomized, open-label study designed to evaluate the efficacy and safety of venetoclax versus rituximab in patients with R/R CLL compared with standard chemotherapy. The primary endpoint of the study was the progression-free survival (PFS) assessed by the investigator.
â–²Venetoclax molecular structure (Source: Wikipedia)
The results showed that patients receiving venetoclax and rituximab had better PFS than the standard treatment group, and the median PFS was not achieved, compared with 17 months in the standard treatment group (HR=0.17, 95% CI: 0.11-0.25, p<0.0001). The 24-month PFS rate was 84.9% and 36.3% in the combination and standard treatment groups, respectively. The PFS assessed by the Independent Review Board is similar. The key secondary efficacy endpoints showed consistent outcomes: the combined treatment group had significantly improved overall survival (OS) (HR=0.48, 95% CI: 0.25-0.90); the investigator assessed ORR in the combination treatment group and standard treatment The group was 93.3% and 67.7%, respectively; the CR rate was 26.8% and 8.2%, respectively; the peripheral blood MRD- rate (83.5%) was higher in the combination group than in the standard treatment group (23.1%). In addition, the safety of venetoclax and rituximab combination therapy is consistent with the results of the known scheme.
The investigators believe that MURANO is the first phase III clinical study of the R/R CLL study, showing a significantly improved PFS compared to standard chemotherapy immunotherapy and consistent results across all risk subgroups. Key secondary endpoints (including OS, ORR, and CR rates) also showed consistent improvement, while peripheral blood MRD-rates significantly exceeded the levels of previous R/R CLL treatments.
We look forward to seeing the specific results of this study at the conference and hope that this new combination therapy will bring disease relief to patients as soon as possible.
Reference materials:
[1] LBA-2 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
[2] #ASH17: Late breaker from AbbVie, Roche highlights a blockbuster breakout opportunity for Venclexta in CLL
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