五马进击 一马当先?SERD 进度更新
王菲家的Amcenestrant (SAR439859)
Ameera-5 Ph3: Amcenestrant+Ibrance+来曲唑模拟片±戈舍瑞林 vs Amcenestrant模拟片+Ibrance+来曲唑±如戈舍瑞林 一线治疗ER+/HER2- BC,入排囊括了绝经前、围绝经期和绝经后的女性以及男性——除了绝经后女性都需要同时接受戈舍瑞林治疗,下面连2个1L相同,主要终点PFS,FPI是20Q4
https://clinicaltrials.gov/ct2/show/NCT04478266
老罗家的Giredestrant (RG6171)
BO41843 Ph3:Giredestrant (RG6171)+来曲唑模拟片+Ibrance±LHRH激动剂(如戈舍瑞林) vs Giredestrant (RG6171)模拟片+来曲唑+Ibrance±LHRH激动剂(如戈舍瑞林) 一线治疗ER+/HER2- BC,主要终点也是PFS,FPI是20Q4
https://clinicaltrials.gov/ct2/show/NCT04546009
网易的Camizestrant (AZD9833)
Serena-4 Ph3:Camizestrant (AZD9833)+来曲唑模拟片+Ibrance±LHRH激动剂(如戈舍瑞林)vs Camizestrant (AZD9833)模拟片+来曲唑+Ibrance±LHRH激动剂(如戈舍瑞林)一线治疗ER+/HER2- BC,主要终点也是PFS,FPI则是20Q4
https://clinicaltrials.gov/ct2/show/NCT04711252
其他进度
上面是三家口服SERD一线治疗的情况,另外Elacestrant和Giredestrant (RG6171)也开了对比SoC用于 2-3线治疗
Giredestrant (RG6171)
https://clinicaltrials.gov/ct2/show/NCT04576455
Giredestrant (RG6171)对比氟维司群或AI用于2-3线,入组标准:Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced (recurrent or progressed) or metastatic setting,主要终点PFS,FPI是20Q4
Radius Health/ Menarini的Elacestrant
Emerald:Elacestrant 对比SoC(氟维司群 or 阿那曲唑 or 来曲唑 or 依西美坦)用于CDKi经治的ER+/HER2- BC,也是唯一只入组绝经后的女性或是男性,另外患者先前可以接受过1-2轮治疗:其中必须包括一轮CDKi联合氟维司群或AI,另外可以接受不超过一轮化疗,患者随机前必须ctDNA 检测确认ESR1-mut 或 ESR1-WT,主要终点是ESR1-mut及所有人群的PFS,预计今年有readout
https://clinicaltrials.gov/ct2/show/NCT03778931
前人田地后人收,说甚龙争虎斗
牢记“两个务必”,决不能当李自成,否则best in class永远只是potential