武田制药将呈报ICLUSIG® (ponatinib) 2期OPTIC试验主要分析的阳性结果,加强填补慢性期CML治疗空白的能力

2021-05-24 网络 网络

武田药品工业株式会社今天宣布,2期OPTIC试验主要分析的阳性结果,加强填补慢性期CML治疗空白的能力

武田药品工业株式会社(Takeda Pharmaceutical Company Limited, TSE:4502/NYSE:TAK)(“武田”)今天宣布,2期OPTIC(Optimizing Ponatinib Treatment ICML,优化ponatinib治疗CML)试验主要分析数据将在线上召开的美国临床肿瘤学会(ASCO)第57届年会和欧洲血液学会(EHA)第26届年会上口述呈报。OPTIC试验是一项随机、开放研究,前瞻性评估三种起始剂量(45、30或15毫克)范围内的ICLUSIG® (ponatinib)基于缓解的给药方案,旨在优化其对先前酪氨酸激酶抑制剂(TKI)治疗耐药或不耐受的慢性期慢性粒细胞白血病(CP-CML)患者的有效性和安全性。

OPTIC试验评估伴有或不伴突变的耐药患者的治疗,达到其主要终点。研究显示,CP-CML患者可从ICLUSIG每天45毫克起始剂量获得最佳收益风险比,当BCR-ABL1 IS ≤1%时,剂量可减至15毫克。该结果同时提示,ICLUSIG的安全性和动脉闭塞事件(AOE)属临床可处治。

OPTIC试验主要研究者、奥古斯塔大学佐治亚州癌症中心Jorge Cortes, MD表示:“对OPTIC数据的主要分析强调,ICLUSIG对耐药和不耐受的慢性期CML患者的处治极具价值。两个或更多TKI失效后,应考虑使用ICLUSIG。这种方法可尽可能减少接替使用第二代TKI的需求,后者通常导致低缓解率和不良转归。上述发现进一步显示,通过基于缓解的给药方案能获得较佳的ICLUSIG收益风险比,在降低动脉闭塞事件风险的同时提供有效性。”

OPTIC数据于2020年在线上召开的ASCO第56届和EHA第25届年会上首次呈报,展示来自中期分析(截止日期为2019年7月)的修订版ICLUSIG收益风险转归,评估216例患者,中位随访21个月。本次主要分析评估283例患者,中位随访32个月,强调该耐药CP-CML患者人群在更长的随访期内阳性的、延长的缓解持续时间,同时保持安全性可处治。

武田肿瘤治疗领域部主管Christopher Arendt博士表示:“由于慢性期CML能得到有效控制,人们误以为它是一种'良性癌症',但对于耐药和不耐受疾病的患者,坚持研究和治疗选择至关重要。OPTIC主要分析巩固了我们对ICLUSIG如何能填补此类患者治疗空白的理解。OPTIC数据,加上美国食品药品管理局(FDA)近期更新的适应证,展示了ICLUSIG作为第三代TKI所能提供的效益。”

2020年12月,依据OPTIC数据,美国食品药品管理局核准了ICLUSIG的补充新药申请(sNDA)。更新版说明书纳入一项用于对至少两种先前激酶抑制剂耐药或不耐受的CP-CML成人患者的扩大适应证,以及基于缓解的优化给药方案。

OPTIC主要分析:三种起始剂量ponatinib (PON)的剂量优化研究。

Jorge Cortes博士将呈报的关键发现包括:

  • 通过主要分析(截止日期为2020年5月),中位随访32个月,OPTIC试验中100%的患者可评估为主要终点。
  • 45毫克/日起始剂量队列在12个月时达到≤1% BCR-ABL1IS的最高比例(44.1%),该队列73.3%的患者在剂量减至15毫克/日后维持缓解。30毫克/日和15毫克/日队列同样显示效益(分别为29%和23%),尤其是在耐药较少且无T315I突变的患者中。
  • 所有三组均观察到阳性生存转归,36个月时,45毫克起始剂量队列的预期总生存(OS)率为89%、预期无进展生存(PFS)率为73%。
  • 这表明无论是先前的第二代TKI耐药还是存在BCR-ABL1突变,减低剂量的策略均不会影响总生存。
  • 主要分析时观察到的动脉闭塞事件(AOE)发生率(总体为6%,45毫克队列为9.6%)提示,安全性和AOE属临床可处治。
  • 安全数据包括:
    • 在所有患者中(N = 283例),最常见的3度或更高等级的治疗中出现的不良事件(TEAE)为血小板减少(27%)、中性粒细胞减少(17%)和贫血(7%)。
    • 45、30、15毫克/日起始剂量组报告的AOE分别为10%、5%和3%。45、30、15毫克/日起始剂量组3度或更高等级的AOE分别为5%、5%和3%。
    • 45、30、15毫克/日起始剂量队列报告的严重AOE分别为4%、4%和3%。有四例死亡与AE相关(猝死2例、肺炎2例)。

欲了解有关武田肿瘤布局的更多信息,请参加今年的ASCOEHA年会。武田将于美国东部时间6月8日周二下午6:30召开面向分析师和投资者的网络广播,讨论ASCO上呈报的上述及其他数据,并提供有关肿瘤产品线的最新信息。欲了解更多细节,请联系TakedaRandDEvents@fticonsulting.com。演示幻灯片和网络广播的存档回放,请访问https://www.takeda.com/investors/reports/ir-events/

关于OPTIC试验

OPTIC(Optimizing Ponatinib Treatment In CML,优化Ponatinib治疗CML)是一项进行中的随机剂量范围试验,旨在评估ICLUSIG 3种起始剂量(45毫克、30毫克、15毫克)治疗耐药型慢性期慢性粒细胞白血病(CP-CML)或存在先前接受任何数目TKI后T315I突变历史记录的患者。按研究方案,如果出现缓解,即予减量。预计该试验将有望为上述患者提供使用ICLUSIG® (ponatinib)的最佳剂量。全球各临床研究单位282例患者入组,其中94例患者接受45毫克起始剂量。该试验主要终点是在12个月时达到BCR-ABL1IS ≤1%。

OPTIC数据显示,对先前TKI治疗药物高度耐药的、伴有或不伴突变的CP-CML患者中,基于缓解的ICLUSIG给药方案(即当达到BCR-ABL1IS ≤1%时,剂量由45毫克/日降至15毫克/日)能获得最佳收益风险比。12个月时,接受45毫克起始剂量的患者中,44% (41/93)达到BCR-ABL1IS ≤1%。OPTIC研究显示,中位随访32个月时,ICLUSIG 45毫克降至15毫克的患者中,73%保持缓解。上述患者中,10%发生任何等级的AOE,5%发生3度或更高等级。发生率> 15%的最常见TEAE有:血小板减少、高血压、头痛、中性粒细胞减少、贫血、头痛、脂肪酶升高、丙氨酸转氨酶(ALT)升高和关节痛。

关于CMLPh+ ALL

CML属于罕见恶性肿瘤,是白血病四大类型之一;由粒细胞早期未成熟版本中发生的基因突变所致,这些粒细胞可形成红细胞、血小板和多数类型的白细胞。随后形成一种称为BCR-ABL1的异常基因,将受损细胞转化为CML细胞。CML通常进展缓慢,但也可转变为生长迅速的急性白血病,从而难以治疗。

Ph+ ALL是一种罕见类型的ALL,累及美国约25%的成人ALL患者,其特征是存在一种称为费城染色体的异常基因。费城染色体阳性(Ph+)患者中,第9号染色体与第22号染色体的片段互换形成一条异常染色体。该互换导致第9号染色体变长,而第22号染色体变短,从而形成BCR-ABL1,并与Ph+ ALL相关。

关于ICLUSIG® (ponatinib)

ICLUSIG是一种激酶抑制剂,靶向作用于BCR-ABL1,这是CML和Ph+ ALL中表达的一种异常酪氨酸激酶。ICLUSIG属于靶向抗癌药,其设计采用了一种基于计算及结构的药物设计平台,针对性地抑制BCR-ABL1及其突变的活性。ICLUSIG抑制本体BCR-ABL1,同时抑制所有BCR-ABL1治疗耐药性突变,包括耐药性最强的T315I突变。ICLUSIG是唯一获得批准的TKI,其显示出对BCR-ABL1的T315I关守突变的活性。该突变与对所有其他批准的TKI的耐药相关。ICLUSIG于2016年11月获得FDA的全面批准。ICLUSIG适用于治疗对至少2种先前激酶抑制剂耐药或不耐受的慢性期(CP) CML、加速期(AP)或急变期(BP) CML或其他任何激酶抑制剂均不适用的Ph+ ALL成人患者,以及治疗T315I+ CML(CP、AP或BP)或T315I阳性Ph+ ALL成人患者。ICLUSIG不适用、也不推荐用于治疗新诊断的CP-CML患者。

重要安全性信息

 

警示:动脉阻塞事件、静脉血栓栓塞事件、心力衰竭和肝脏毒性

 

有关完整的加框警示语,请参阅完整处方信息。

 

  • ICLUSIG治疗的患者中有发生动脉阻塞事件(AOE)的情况,包括致死性病例。AOE包括致死性心肌梗塞、卒中、脑部大动脉狭窄、重度周围血管疾病,以及需要急诊血管再通手术。伴有或不伴有心血管危险因素的患者,包括50岁以下患者,曾经发生上述事件。应监测患者有无AOE。按严重程度,暂停或停用ICLUSIG。决定是否重启治疗时,应权衡收益风险比。
  • ICLUSIG治疗的患者有发生静脉血栓栓塞事件(VTE)的情况。应监测患者有无VTE按严重程度,暂停或停用ICLUSIG
  • ICLUSIG治疗的患者有发生心力衰竭,包括致死性病例。应监测患者有无心力衰竭,按临床指征进行处治。若有心力衰竭新发或恶化,应暂停或停用ICLUSIG
  • ICLUSIG治疗的患者有发生肝脏毒性、肝功能衰竭和死亡的情况。应监测肝功能检测的结果。按严重程度,暂停或停用ICLUSIG

警示与注意事项

动脉阻塞事件(AOE)OPTIC和PACE中,经ICLUSIG治疗的患者均有发生AOE的情况,包括致死性病例。这些事件包括心血管、脑血管和周围血管事件。OPTIC(45毫克→15毫克)的94例患者中,AOE发生率为13%;5%为3度或4度。PACE的449例患者中,AOE发生率为26%;14%的患者为3度或4度。致死性AOE发生率,OPTIC中为2.1%,PACE中为2%。部分PACE患者发生复发性或多部位血管阻塞。伴有或不伴心血管危险因素的患者(包括50岁或以下患者)均发生上述事件。PACE中,上述事件中观察到的最常见危险因素是高血压、高胆固醇血症和非缺血性心脏病史。OPTIC和PACE中,年龄较大者AOE较多见。

OPTIC剔除了高血压或糖尿病失控患者以及伴有临床意义、失控或活动性心血管疾病的患者。PACE剔除了ICLUSIG首次给药前3个月内高甘油三酯血症失控患者以及伴有临床意义或活动性心血管疾病的患者。应权衡ICLUSIG预期收益有无超过风险。

应监测患者有无AOE。应先暂停ICLUSIG,随后按有无复发/严重程度,等量或减量复用或停用。决定是否重启ICLUSIG时,应权衡收益风险比。

静脉血栓栓塞事件(VTE)接受ICLUSIG的患者有发生严重或重度VTE的情况。PACE的449例患者中,VTE发生率为6%,严重或重度(3度或4度)VTE为5.8%。VTE包括:深静脉血栓形成、肺栓塞、血栓性浅静脉炎、视网膜静脉阻塞,以及伴失明的视网膜静脉血栓形成。Ph+ ALL(32例患者的9%)和BP-CML(62例患者的10%)患者的发生率较高。OPTIC的94例患者中,有1例发生VTE(1度视网膜静脉阻塞)。应监测患者有无VTE。应先暂停ICLUSIG,随后按有无复发/严重程度,等量或减量复用或停用。

心力衰竭:接受ICLUSIG的患者有发生严重或重度心力衰竭事件。PACE的449例患者中,心力衰竭发生率为9%;严重或重度(3度或以上)为7%。OPTIC的94例患者中,心力衰竭发生率为12%;严重或重度(3度或4度)为1.1%。PACE中最常见(≥2%)的心力衰竭事件为充血性心力衰竭(3.1%)、射血分数降低(2.9%)和心力衰竭(2%)。OPTIC中最常报告(各组>1例患者)的心力衰竭事件为左心室肥大(2.1%)和BNP升高(2.1%)。应监测患者有无与心力衰竭吻合的体征或症状,按临床指征处治心力衰竭。应先暂停ICLUSIG,随后按心力衰竭有无新发或恶化,减量复用或停用。

肝脏毒性:ICLUSIG能导致肝脏毒性,包括肝功能衰竭和死亡。3例患者发生爆发型肝功能衰竭,导致死亡,其中1例在ICLUSIG启用1周内发生肝功能衰竭。上述致死性病例发生于BP-CML或Ph+ ALL患者。OPTIC的94例患者中,肝脏毒性发生率为25%,PACE的449例患者中,肝脏毒性发生率为32%。OPTIC(94例患者的6%)和PACE(449例患者的13%)中均有3度或4度肝脏毒性。最常见的肝脏毒性事件是下列指标升高:ALT、AST、GGT、胆红素和碱性磷酸酶。应监测基线肝功能,随后至少每月一次或按临床指征复查。应先暂停ICLUSIG,随后按有无复发/严重程度,减量复用或停用。

高血压:接受ICLUSIG的患者有发生严重或重度高血压,包括高血压危象。若高血压伴有意识模糊、头痛、胸痛或气促,可能需要紧急临床干预。应监测基线高血压,随后按临床指征复查并按临床指征处治高血压。若高血压无法用药物控制,应暂停、减量或停用ICLUSIG。若高血压显著恶化、不稳定或难治,应暂停ICLUSIG,并考虑评估有无肾动脉狭窄。

胰腺炎:接受ICLUSIG的患者有发生严重或重度胰腺炎。也可发生脂肪酶和淀粉酶升高。多数病例导致减药或停药,胰腺炎在2周内缓解。用药最初2个月应每2周检查一次血清脂肪酶,随后每月一次或按临床指征复查。有胰腺炎或酗酒史的患者应考虑额外的血清脂肪酶监测。应先暂停ICLUSIG,随后按严重程度,等量或减量复用或停用。若脂肪酶升高伴腹部症状,应评估患者有无胰腺炎。

新诊断慢性期CML中的毒性增加:新诊断CP-CML患者一线治疗的前瞻性随机临床试验显示,ICLUSIG 45毫克单药每天一次的严重不良反应风险是伊马替尼400毫克单药每天一次的2倍。中位治疗暴露期少于6个月。该试验因安全性问题而中止。ICLUSIG组的动静脉血栓形成和阻塞发生率至少是伊马替尼组的2倍。经ICLUSIG治疗患者的下列发生率高于伊马替尼治疗组:骨髓抑制、胰腺炎、肝脏毒性、心力衰竭、高血压、以及皮肤和皮下组织疾病。ICLUSIG不适用、也不推荐用于治疗新诊断的CP-CML患者。

神经病变:OPTIC和PACE患者均有出现周围和颅神经病变。PACE中,部分此类事件为3度或4度。应监测患者有无神经病变症状,例如感觉迟钝、感觉过敏、感觉异常、不适、烧灼感、神经病变性疼痛或无力。应先暂停ICLUSIG,随后按有无复发/严重程度,等量或减量复用或停用。

眼毒性:经ICLUSIG治疗的患者有发生导致失明或视物模糊的严重或重度眼毒性。OPTIC和PACE中最常见的眼毒性有眼干、视物模糊和眼痛。视网膜毒性包括年龄相关黄斑变性、黄斑水肿、视网膜静脉阻塞、视网膜出血和玻璃体浮物感。基线时及治疗期间应定期开展全面的眼科检查。

出血:接受ICLUSIG的患者中有发生致死性及严重出血。PACE中有发生致死性出血,OPTIC和PACE中有发生严重出血。AP-CML、BP-CML和Ph+ ALL患者严重出血事件发生率较高。胃肠道出血和硬膜下血肿是最常报告的严重出血事件。事件常见于4度血小板减少患者。应监测患者有无出血,并按临床指征处治患者。应先暂停ICLUSIG,随后按有无复发/严重程度,等量或减量复用或停用。

体液潴留:接受ICLUSIG的患者有发生致死性及严重体液潴留。PACE中有1例脑水肿属致死性,严重事件包括胸膜积液、心包积液和血管性水肿。应监测患者有无体液潴留,并按临床指征处治患者。应先暂停ICLUSIG,随后按有无复发/严重程度,等量或减量复用或停用。

心律不齐: OPTIC和PACE患者中均有发生心律不齐,包括室性和房性心律不齐。部分患者的事件属严重或重度(3度或4度),导致住院。应监测患者有无提示心率过缓(昏厥、头晕)或心率过快(胸痛、心悸或头晕)的体征及症状,并按临床指征处治患者。应先暂停ICLUSIG,随后按有无复发/严重程度,等量或减量复用或停用。

骨髓抑制:OPTIC和PACE患者中均有发生3度或4度中性粒细胞减少、血小板减少和贫血。AP-CML、BP-CML、Ph+ ALL患者的骨髓抑制发生率大于CP-CML患者。最初3个月应每2周检查一次全血细胞计数,随后每月一次或按临床指征复查。如果ANC低于1 x 109/升或血小板低于50 x 109/升,应先暂停ICLUSIG,直至ANC至少1.5 x 109/升且血小板至少75 x 109/升,随后等量或减量复用。

肿瘤溶解综合征(TLS)OPTIC和PACE的治疗患者中均有严重TLS的报告。在启用ICLUSIG治疗之前,应确保足量补液,并处治高尿酸水平。

可逆性后部白质脑病综合征(RPLS)接受ICLUSIG的患者中有发生RPLS(又名后部可逆性脑病综合征)的报告。高血压可能与神经系统体征和症状伴发。根据脑磁共振成像(MRI)的支持性发现进行诊断。应先暂停ICLUSIG直至缓解。RPLS缓解后复用ICLUSIG的安全性属未知。

伤口愈合受损和胃肠道穿孔:接受ICLUSIG的患者有发生伤口愈合受损。应在择期手术之前至少1周暂停ICLUSIG。大手术后至少2周内和伤口充分愈合之前不应给药。伤口愈合并发症缓解后重启ICLUSIG的安全性尚不明确。接受ICLUSIG的患者有发生胃肠道穿孔或瘘。胃肠道穿孔患者应永久性停用。

胚胎胎儿毒性:按其作用机制和动物研究结果,孕妇服用ICLUSIG可损害胎儿。动物生殖研究显示,在低于人类推荐剂量的暴露量时,可引起不良发育效应。应告知孕妇该药对胎儿有潜在风险。育龄女性在ICLUSIG治疗期间及末次给药后3周内应采取有效的避孕。

不良反应

最常见(>20%)的不良反应有皮疹及相关病况、关节痛、腹痛、头痛、便秘、皮肤干燥、高血压、疲乏、体液潴留暨水肿、发热、恶心、胰腺炎/脂肪酶升高、出血、贫血、肝功能障碍和AOE。最常见(>20%)的3度或4度实验室异常有血小板计数降低、中性粒细胞计数降低和白细胞减少。

 

如需报告疑似不良反应,请拨打武田药品工业株式会社电话1-844-817-6468FDA电话1-800-FDA-1088或访问www.fda.gov/medwatch

药物相互作用

CYP3A强抑制剂应避免合并用药,若合并用药无法避免,ICLUSIG应减量。

CYP3A强诱导剂避免合并使用。

特殊人群用药

育龄男女:育龄女性在启用ICLUSIG之前应验证妊娠状态。

Ponatinib可能损害女性生育力,此类效应是否可逆尚属未知。

哺乳:建议女性在ICLUSIG治疗期间及末次给药后6天内避免授乳。

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    2022-02-06 liye789132251
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    2021-05-26 wangbingxhy
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