$礼来(LLY)$ pirtobrutinib的3期临床中期分析。在对伊布替尼的细分组里面ORR更好,PFS有更好的趋势但还不统计显著,OS没有恶化的趋势。
这临床设计的不直接。没有回答一个核心问题:pirtobrutinib和泽布替尼谁更好。想回答这个问题非常简单,直接设计一个头对头泽布就好了,但礼来没这么做。他们或许想找一个更容易上市的路径:比伊布替尼好就行了。反正靠销售也能拿一些份额有机会成为一个重磅适应症。而且这临床数据的用词有点意思:No detriment was observed for overall survival (OS). OS没恶化。翻译过来其实意思就是OS没有变好。因为如果OS有变好的趋势,用词会是类似PFS这种:我们观察到OS变好的趋势,但还未统计显著性,在未来等数据成熟会继续测试。
INDIANAPOLIS, July 29, 2025 /PRNewswire/ -- Eli Lilly and Company today announced positive topline results from the Phase 3 BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). This study enrolled patients with treatment-naïve CLL/SLL and those who had been previously treated but were BTK inhibitor-naïve. The study met its primary endpoint of non-inferiority on overall response rate (ORR) as assessed by an independent review committee (IRC) in both the pre-treated and intent-to-treat populations. ORR favored pirtobrutinib with a nominal P-value for superiority1 (p <0.05). Progression free survival (PFS), a key secondary endpoint, was not yet mature at this analysis, but was trending in favor of pirtobrutinib. A formal PFS analysis testing for superiority is planned at a future analysis. No detriment was observed for overall survival (OS).