nsq-nsclc HR0.77都没有统计优效啊。会不会是样本数太少了
我重新读了一下,看了一下wording,很可能non sq人群 HR上限是<1的,达到数值上的统计显著性。但由于预设的是全人群的分析,所以PR在non sq 亚组中不能claim stat significant,可以看对于PFS的写法。
datopotamab deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC.
所以在non sq 人群疗效可能不错,等ASCO数据。
应该是ITT人群 OS HR 0.90,没有达到统计学意义;NSQ人群OS HR 0.77,有临床意义的改善;
申报上市针对的是【既往接受过全身治疗的局部晚期或转移性非鳞状NSCLC患者】
官宣了么
乳腺癌也是pfs获益,os估计也悬
In the overall trial population, survival results numerically favoured AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan but did not reach statistical significance
TROPION-Lung01 previously met the dual primary endpoint
of progression-free survival in the overall trial population
Results support applications currently under review by
regulatory authorities globally including in the US and EU