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基石药业-B(02616.HK):CS1001联合化疗一线治疗食管鳞癌III期临床试验完成首例患者给药
格隆汇 01-07 20:15

格隆汇1月7日丨基石药业-B(02616.HK)发布公告,公司抗PD-L1单抗CS1001联合化疗一线治疗晚期食管鳞癌的III期临床试验已完成首例患者给药。该项名为GEMSTONE-304的多中心临床试验,旨在评估CS1001联合氟尿嘧啶和顺铂(“FP”)化疗方案作为一线治疗在不可手术切除的局部晚期、复发或转移性食管鳞癌患者中的疗效和安全性。

据统计,约90%的中国食管癌患者为食管鳞癌,且约70%的食管鳞癌患者在确诊时已为局部晚期或晚期转移性。目前晚期食管鳞癌患者的标准一线治疗方案为含铂类药物的双药化疗方案,但疗效非常有限。研究资料显示,经过该一线方案治疗的晚期食管鳞癌患者,客观有效率(“ORR”)约为35%,中位无进展生存期不足半年,中位总生存期不到一年,且患者暂无其它有效治疗选择。

CS1001是由基石药业开发的在研抗PD-L1单克隆抗体。根据2019年中国临床肿瘤学会年会上公布的研究资料,截至2019年7月1日,在CS1001联合FP方案用于一线食管鳞癌的1b期临床试验中,ORR达到77.8%,且缓解可持续,同时,总体安全性及耐受性良好。

基石药业董事长、执行董事兼首席执行官江宁军博士表示:“食管癌是具有中国特色的高发癌种,中国发病和死亡人数占到全球50%以上。然而,目前中国针对食管鳞癌的治疗手段已多年未取得突破,患者在临床上存在长期、迫切的未满足需求。我很高兴看到GEMSTONE-304研究完成了首例受试者给药,期待CS1001能延续其在初步研究中显示出的巨大治疗潜力,早日成为中国食管鳞癌患者新的治疗选择。”

基石药业首席医学官杨建新博士表示:“由于食管癌早期症状隐匿,患者确诊时往往已处于晚期,治疗手段十分有限,且目前尚无免疫药物获批用于一线食管鳞癌的治疗。目前已公布的Ib期临床研究资料表明,CS1001在晚期食管鳞癌患者中已显示出良好的初步抗肿瘤活性。我们将全力推进CS1001的该项III期临床试验,如果试验能够取得成功,对于急需有效药物的晚期食管鳞癌患者来说,将是一个巨大的突破。”

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