正在进行局部晚期转移性肝癌的联合治疗试验

StephenW

Combination therapy trial for locally advanced, metastatic HCC underway
January 16, 2020

CStone Pharmaceuticals and Blueprint Medicines Corporation announced the first patient dosed in a phase 1b/2 trial of fisobatinib in combination with CS1001 for the treatment of locally advanced or metastatic hepatocellular carcinoma, according to a press release.

Investigators will assess the potential for two complementary treatment approaches including precision therapy and immune-oncology therapy to enhance anti-tumor activity at multiple clinical sites in China.

“HCC is a particularly aggressive disease and China is currently faced with enormous challenges due to limited effective treatment options and poor prognosis in HCC patients at advanced stages,” Archie Tse, MD, PhD, chief translational medicine officer at CStone, said in the release. “CStone is committed to addressing unmet clinical needs through identifying potentially transformative combination regimens against complex cancers like HCC.”

Fisogatinib is an investigational, potent and highly-selective inhibitor of fibroblast growth factor receptor 4 discovered by Blueprint Medicines. Data from an ongoing phase 1 trial showed that fisogatinib monotherapy was clinically active and well-tolerated in patients with heavily pretreated advanced HCC.

CS1001 is an investigational anti-PD-L1 monoclonal antibody under development by CStone for multiple tumor types. Data from a phase 1 dose-escalation study of CS1001 demonstrated sustained clinical benefits in gastric cancer and esophageal cancer. Additionally, pooled safety data from the phase 1b trial showed that CS1001 had a promising safety and tolerability profile.

“We look forward to advancing our fisogatinib clinical program by conducting a phase 1b/2 trial in China, where the incidence of HCC is disproportionately high,” Andy Boral, MD, PhD, chief medical officer at Blueprint Medicines, said. “Because fisogatinib has exquisite selectivity against an oncogenic driver, we believe this investigational treatment is well-positioned for combination therapy.”

Reference: www.cstonepharma.com

StephenW

正在进行局部晚期转移性肝癌的联合治疗试验
2020年1月16日

根据新闻稿，CStone Pharmaceuticals and Blueprint Medicines Corporation宣布了第一名在Fisobatinib与CS1001联合进行的1b / 2期试验中接受治疗的局部患者，该患者用于治疗局部晚期或转移性肝细胞癌。

研究人员将评估两种互补疗法的潜力，包括精确疗法和免疫肿瘤疗法，以增强中国多个临床场所的抗肿瘤活性。

CStone首席转化医学官医学博士Archie Tse表示：“ HCC是一种特别具有侵略性的疾病，由于有效的治疗选择有限，晚期HCC患者的预后较差，中国目前面临着巨大挑战。” 。 “ CStone致力于通过确定针对HCC等复杂癌症的潜在转化组合方案来满足未满足的临床需求。”

Fisogatinib是Blueprint Medicines发现的一种研究性，有效且高选择性的成纤维细胞生长因子受体4抑制剂。正在进行的1期临床试验的数据表明，非索格替尼单药治疗在经过高度预处理的晚期HCC患者中具有临床活性并且耐受性良好。

CS1001是由CStone开发的针对多种肿瘤类型的研究性抗PD-L1单克隆抗体。来自CS1001的1期剂量递增研究的数据表明，在胃癌和食道癌中具有持续的临床益处。此外，来自1b期临床试验的汇总安全数据表明CS1001具有令人鼓舞的安全性和耐受性特征。

Blueprint Medicines首席医学官Andy Boral医师表示：“我们期待通过在中国进行1b / 2期临床试验来推进fisogatinib的临床计划，因为在中国，HCC的发病率异常高。” “由于fisogatinib对致癌驱动物具有出色的选择性，因此我们认为这种研究性治疗方法很适合联合治疗。”

参考：www.cstonepharma.com