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Article source: Pharmaceutical Guanlan
On July 30, BeiGene announced that the interim analysis of a global Phase 3 SEQUOIA trial of BTK inhibitor Zebutinib (Bai Yue Ze) has achieved positive main results, and the study has reached its primary endpoint
Zebutinib is a small molecule inhibitor of BTK independently developed by BeiGene scientists.
SEQUOIA is a randomized, multicenter, global phase 3 trial with more than 580 patients enrolled, aiming to evaluate the use of zebutinib and bendamustine in combination with rituximab (B+R) for treatment The effectiveness and safety of newly treated CLL or small lymphocytic lymphoma (SLL) patients
At a median follow-up time of 25.
In addition, the SEQUOIA trial showed that as a secondary endpoint, PFS based on the investigator's assessment also showed a statistically significant improvement
CLL is the most common type of leukemia in adults.
BeiGene said it will communicate with global drug regulatory agencies on the next step and announce these data at the upcoming important medical conference
Previously, Zebutinib has been approved for multiple indications in the United States, China, the United Arab Emirates, Canada, Israel and other countries or regions, and has conducted nearly 30 clinical trials for 8 indications worldwide
Note: The original text has been deleted
references:
[1]American Cancer Society.
[2]Global Burden of Disease Cancer Collaboration.
[3]National Cancer Institute.
[4]Haselager MV et al.
[5]Cancer Support Community.
