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TOKUSHIMA, Japan--(BUSINESS WIRE)--We are excited to share our latest development status.
日本德岛--(商业新闻短讯)--我们很高兴分享我们的最新发展状况。
As informed dated October 28th, an interim analysis for the Phase III study of DFP-10917 in R/R AML patients is ongoing. The Phase I/II combination study of DFP-10917 with Venetoclax in AML patients is well ongoing.
根据10月28日的通知,正在进行R/R AML患者DFP-10917 III期研究的中期分析。DFP-10917与Venetoclax在AML患者中的I/II期联合研究正在进行中。
Today, we are delighted to talk about an update for development of the drug delivery of DFP-10917 selective to solid tumor, which is namely, DFP-14927 showed nice safety and efficacy in the Phase I study in solid tumor patients. Accordingly, we have moved forward into an expanded Phase I study of DFP-14927 at 3200 mg/m2 weekly dosing in R/R colorectal cancer patients at MD Anderson Cancer Center and UCLA.
。因此,我们在MD安德森癌症中心和加州大学洛杉矶分校的R/R结直肠癌患者中,以每周3200 mg/m2的剂量对DFP-14927进行了扩展的I期研究。
Efficacy in expanded Phase I study is evaluated by Disease Control Ratio (DCR) and it shall be evaluated by OS in the next registration study for NDA approval..
扩展I期研究的疗效通过疾病控制率(DCR)进行评估,并应由OS在下一次注册研究中进行评估,以获得NDA批准。。