AACR 2022:第二代PARP1选择性抑制剂首次人体试验结果公布

2022-04-11 MedSci原创 MedSci原创

2021年9月7日,CDE官网显示,阿斯利康的 PARP1 选择性抑制剂获批临床,用于晚期恶性实体瘤。这是一款PARP1选择性抑制剂,相较于阿斯利康已上市的 PARP1/2 抑制剂奥拉帕利,AZD53

2021年9月7日,CDE官网显示,阿斯利康的 PARP1 选择性抑制剂获批临床,用于晚期恶性实体瘤。这是一款PARP1选择性抑制剂,相较于阿斯利康已上市的 PARP1/2 抑制剂奥拉帕利,AZD5305有望克服已上市 PARP 抑制剂的副作用。

PARP,即聚腺苷酸二磷酸核糖基聚合酶(poly ADP-ribose polymerase),是一类存在于真核细胞中催化聚 ADP 核糖基[poly(ADP-ribose),PAR]化的细胞核酶,属于一种关键的DNA修复酶,包括 PARP1、PARP2、PARP3等18个成员,在DNA损伤应答与修复、调控细胞凋亡、维持基因组稳定等方面具有重要作用。PARP抑制剂是"合成致死"这一抗肿瘤理念运用于新药开发最成功的案例。

第一代双PARP1/2抑制剂(PARPi)的部分不良反应可能来自对于 PARP2 的抑制,而 PARP2 并非疗效所必须。因此,选择性抑制PARP1,会使疗效更好,安全性更佳。

与第一代双PARP1/2抑制剂(PARPi)相比,AZD5305对PARP1具有高效的、高选择性抑制和捕获作用,临床前结果显示其具有优越的耐受性、靶点结合率和疗效。此研究是对正在进行的1/2a期PETRA(NCT04644068)试验结果的第一次报告。

在携带胚系或体细胞BRCA1/2、PALB2或RAD51C/D突变的晚期乳腺癌卵巢癌、前列腺癌或胰腺癌患者中,AZD5305每天口服一次直至疾病进展。入组条件包括:ECOG PS评分0-2、血红蛋白≥90g/L,允许既往接受过PARPi和铂类药物治疗。主要研究终点是安全性;次要研究终点包括:通过检测肿瘤和/或血液样本分析的药代动力学(PK)和药效学以及根据RECIST v1.1标准,CA125或PSA对疗效的评估。探索性分析包括基因组杂合性评估和ctDNA监测。

截止2021年11月17日,46名患者每天口服AZD5305 10-90mg(43.5%曾接受过PARPi治疗;中位治疗线数为3.5)。AZD5305在没有达到剂量限制性毒性之前,在所有剂量下都具有很好的耐受性(表)。PK暴露与剂量成正比。稳定下的血药浓度高于第一代PARPi:分别比10mg和90mg第一代PARPi有效浓度高6.3和31.9倍。

 

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在10-40mg QD剂量下,AZD5305对聚二磷酸腺苷核糖基化(PARylation)的抑制≥90%,证实了其与靶点有效结合。在25名患者中7名(28%)有客观响应:5名RECIST标准评估达到PR(3名确认),另外2名为PSA50应答,包括铂耐药和PARPi耐药患者。22名RECIST可评估患者中,13名(59%)达到SD或PR的时间长达51周以上。13名患者在不同给药剂量下,7名(54%)(3名完全缓解,4名消退>50%)在治疗中ctDNA均有下降。

去年公布的结果中显示,AZD5305仅在BRCA突变细胞中造成DNA损伤积累,而对BRCA野生型细胞无害;在动物实验中,AZD5305 0.1 mg/kg剂量的抗肿瘤活性与奥拉帕利100 mg/kg剂量相当,且其抗肿瘤活性在停止用药后仍能持续存在。此外,基于AZD5305对PARP1捕获的高度特异性,大鼠模型中未发现其会导致血液学毒性,即使与卡铂联用,大鼠的血小板数量也能得以保存;且与奥拉帕利联合治疗方案相比,AZD5305联合治疗时大鼠的红细胞计数恢复更快。由于具有更高的特异性,AZD5305有望降低PARP抑制剂的安全性风险,优化PARP抑制剂的治疗范围,为化疗和靶向药物联合治疗提供新的机会。

AZD5305是一种高选择性的PARP1抑制剂和捕集剂,具有优异的理化性质和广泛的治疗指数。即使经过第一代PARPi治疗,它仍可以与靶点最大化结合,显示良好的临床活性和耐受性。

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  4. 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time=2022-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552038, encodeId=46b41552038db, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Wed Apr 13 00:42:23 CST 2022, time=2022-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621394, encodeId=6905162139410, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, 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  5. [GetPortalCommentsPageByObjectIdResponse(id=1852939, encodeId=12801852939e5, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Mon Dec 12 18:42:23 CST 2022, time=2022-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1922997, encodeId=da29192299e75, content=<a href='/topic/show?id=78f794e800a' target=_blank style='color:#2F92EE;'>#选择性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94780, encryptionId=78f794e800a, topicName=选择性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a0802500050, 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  6. 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href='/topic/show?id=e7c018e7af' target=_blank style='color:#2F92EE;'>#ACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1877, encryptionId=e7c018e7af, topicName=ACR)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19792261142, createdName=10518094zz, createdTime=Wed Apr 13 00:42:23 CST 2022, time=2022-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1513651, encodeId=5f0b1513651a1, content=<a href='/topic/show?id=c41924e0391' target=_blank style='color:#2F92EE;'>#人体试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24703, encryptionId=c41924e0391, topicName=人体试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d9ab10580029, createdName=ms5906905816781247, createdTime=Wed Apr 13 00:42:23 CST 2022, time=2022-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552038, encodeId=46b41552038db, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Wed Apr 13 00:42:23 CST 2022, time=2022-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621394, encodeId=6905162139410, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, 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    2022-04-13 10518094zz
  7. 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    2022-04-13 Luyuxie_14
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