Lazertinib进入Phase 3:悄悄的进村 打枪的不要
Lazertinib 1/2期临床研究
前段时间柳叶刀在线,127例EGFR TKI经治的NSCLC患者(85% T790M+),整体ORR 54%,DCR 87%,mPFS 9.5 mo。其中T790M+的ORR 57% ,PFS 9.7mo
安全性比较好,皮疹和腹泻比Osi少一些,但是肺炎较高:27% any Gr +3% G3(Osi中是13%和0%)
来源:
https://clinicaltrials.gov/ct2/show/NCT04248829
本来以为是JNJ推进的,后来一看是Yuhan
Sites也都是在棒子那(图不全)
380人的随机双盲,2月份开始入组了,不知道疫情影响下进度怎么样了
Lazertinib剂量:初始剂量240mg QD 后可以调整至160mg
主要终点:研究者评估的PFS,次要终点略
后来想想,1.2个billion USD的deal,也就那么回事了
Johnson & Johnson’s Janssen Biotech unit has bought the rights to Yuhan's third-generation EGFR tyrosine kinase inhibitor (TKI) lazertinib in a deal worth up to $1.2 billion.
The deal will see J&J pay the South Korean firm $50 million upfront, while the company may pay $1.2 billion in total if commercial and developmental milestones are met. Double digit royalties on sales may also bolster Yuhan’s purse.
主要还是配合自家的JNJ-372,皇协军混成第二旅团的干活
Ph1a主要是Lazertinib的剂量递增,Ph1b是Lazertinib联合JNJ372