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

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