和记黄埔医药在中国启动索凡替尼胆道癌IIb/III期临床试验

2019-04-02 不详 美通社

2019年3月29日,和黄中国医药科技有限公司(Chi-Med)(AIM/NASDAQ: HCM)子公司和记黄埔医药在中国启动了一项有注册性潜力的IIb/III期临床试验,旨在对比索凡替尼(HMPL-012或sulfatinib)和卡培他滨治疗一线化疗后进展的晚期胆道癌(BTC)的疗效和安全性。BTC是一类异质性的罕见恶性肿瘤,起源于胆道上皮和胆囊,存在巨大的未被满足的医疗需求。2019年3月22

2019年3月29日,和黄中国医药科技有限公司(Chi-Med)(AIM/NASDAQ: HCM)子公司和记黄埔医药在中国启动了一项有注册性潜力的IIb/III期临床试验,旨在对比索凡替尼(HMPL-012或sulfatinib)和卡培他滨治疗一线化疗后进展的晚期胆道癌(BTC)的疗效和安全性。BTC是一类异质性的罕见恶性肿瘤,起源于胆道上皮和胆囊,存在巨大的未被满足的医疗需求。2019年3月22日,首名患者开始接受索凡替尼的治疗。

2019年3月29日,和黄中国医药科技有限公司(Chi-Med)子公司和记黄埔医药在中国启动了一项有注册性潜力的IIb/III期临床试验,旨在对比索凡替尼和卡培他滨治疗一线化疗后进展的晚期胆道癌(BTC)的疗效和安全性。

该研究是一项随机、开放标签、活性对照、多中心研究,旨在对比索凡替尼与化疗药物卡培他滨作为二线疗法治疗不可切除或转移性BTC患者的疗效和安全性。索凡替尼是一种小分子口服抗血管生成-免疫逃逸激酶抑制剂,可同时阻断肿瘤血管生成和免疫逃逸。该研究的主要终点为总生存期(OS)。次要终点包括肿瘤控制相关指标,如无进展生存期(PFS)、客观缓解率(ORR)、疾病控制率(DCR)、缓解持续时间(DOR)、生活质量、肿瘤标志物以及安全性等。该研究的主要研究者为中国人民解放军总医院第五医学中心肠肿瘤科徐建明教授。该研究详情可登陆clinicaltrials.gov,检索NCT03873532查看。

该研究是在两项临床试验的基础上对索凡替尼治疗BTC的进一步探索,这两项临床试验包括一项在中国以BTC为适应症的Ib/II期概念验证研究(clinicaltrials.gov 注册号NCT02966821),以及一项在美国以BTC和胰腺神经内分泌肿瘤(NET)为适应症的Ib期临床试验(clinicaltrials.gov 注册号NCT02549937)。其中,中国Ib/II期概念验证BTC临床试验的研究结果预计将于2019年提交发表。

和记黄埔医药研发中心
和记黄埔医药研发中心

关于索凡替尼

索凡替尼是一种新型的口服抗血管生成-免疫逃逸激酶抑制剂,可通过抑制VEGFR和成纤维细胞生长因子受体(FGFR)来抑制血管生成,索凡替尼也可抑制集落刺激因子-1受体(CSF-1R),通过抑制CSF-1R可调节肿瘤相关巨噬细胞,促进机体对肿瘤细胞的免疫应答。因为具有这种同时抑制血管生成和肿瘤免疫逃逸的作用机制,索凡替尼可能非常适合与其他免疫疗法联用。除了此次启动的BTC研究,索凡替尼目前正在美国和中国开展多项概念验证研究,并在中国开展了多项后期临床试验。

中国胰腺NET研究:2016年,和记黄埔医药在中国启动了一项关键性III期注册研究SANET-p,入组患者为低级别或中级别晚期胰腺NET患者。主要研究终点为PFS。和记黄埔医药计划于2019年年底开展一项中期分析,并在2020年完成患者入组工作(clinicaltrials.gov 注册号NCT02589821)。

中国非胰腺NET研究:2015年12月,和记黄埔医药在中国启动了索凡替尼关键性III期临床试验SANET-ep,入组患者为低级别或中级别晚期非胰腺NET患者。主要研究终点为PFS 。和记黄埔医药计划于2019年中开展一项中期分析,并在2020年完成患者入组工作(clinicaltrials.gov 注册号NCT02588170)。

美国与欧洲胰腺NET研究:由于索凡替尼以胰腺NET为适应症的II期中国临床试验数据令人鼓舞(clinicaltrials.gov 注册号NCT02267967),且美国Ib期临床试验进展顺利,和记黄埔医药决定将计划开展索凡替尼在胰腺NET患者中的注册性研究。

免疫联合疗法:2018年11月,和记黄埔医药达成了两项合作协议,以评估索凡替尼联合免疫检查点抑制剂的安全性、耐受性和疗效,包括:一项与上海君实生物医药科技股份有限公司在全球共同开发索凡替尼与拓益®(特瑞普利单抗,JS001)联合疗法的合作协议,以及一项与泰州翰中生物医药有限公司在中国共同开发索凡替尼与HX008联合疗法的合作协议。拓益®为上海君实生物医药科技股份有限公司研发的一种PD-1单克隆抗体,已于 2018年年底在中国获批。HX008为泰州翰中生物医药有限公司的在研PD-1单克隆抗体。相关安全性研究目前已经启动/处于计划阶段,以确定呋喹替尼与拓益®或HX008组成的联合疗法的安全有效的剂量方案。

关于Chi-Med

和黄中国医药科技有限公司(Chi-Med)(AIM/Nasdaq:HCM)是一家创新型生物医药公司,致力于药品的研究、开发、生产和销售。和记黄埔医药(上海)有限公司是Chi-Med的创新药研发平台,现有一支约420人的研发团队,专注于研发和商业开发治疗癌症和自身免疫性疾病的靶向创新药物和免疫疗法,目前共有8个抗癌类候选药物进入临床阶段,正在全球开展临床研究。Chi-Med的商业平台负责处方药和健康类消费品在中国的生产和营销,销售网络覆盖中国广大地区医院。

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    2019-10-03 hb2008ye
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