CStone开始进行晚期肝癌的联合治疗试验

StephenW

CStone initiates combination therapy trial for advanced liver cancer
June 6, 2019

CStone Pharmaceuticals received approval to initiate clinical development in China of a combination therapy for patients with locally advanced to metastatic hepatocellular carcinoma, according to a press release.

The multicenter, open-label and multidose phase 1b/2 study will evaluate the safety, tolerability and efficacy of CS1001, an anti-PD-LI monoclonal antibody, with BLU-554, a potent and highly selective inhibitor of fibroblast growth factor receptor 4 (FGFR4).
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“Emerging clinical data have shown encouraging results in HCC by combining immunotherapies with targeted therapies that are active as single agents,” Archie Tse, MD, PhD, chief translation medical officer of CStone, said in the release. “The combination of CS1001 and BLU-554 represents a great example of such an approach and a potential first-line treatment strategy for advanced HCC with FGF19-FGFR4 activation. We will rapidly advance the clinical development of this program to further explore these two promising drug candidates in combination.”

CS1001 is also being investigated for the treatment of lung and gastric cancers. Phase 1a data showed CS1001 was well-tolerated and demonstrated anti-tumor activity.

BLU-554 was well-tolerated and demonstrated encouraging anti-tumor activity in a phase 1 study and was granted orphan drug designation for HCC by the FDA.

“One of CStone’s missions is to develop novel therapies to address important unmet needs created by highly prevalent and difficult-to-treat cancers in China. Combination therapy and precision medicine are the core strategies of our pipeline,” Frank Jiang, MD, PhD, chairman and CEO of CStone, said in the release. “We expect the combination of BLU-554 with CS1001 can offer an important additional treatment option for this challenging disease.”

Reference: www.cstonepharma.com

StephenW

CStone开始进行晚期肝癌的联合治疗试验
2019年6月6日

根据一份新闻稿，CStone Pharmaceuticals获准批准在中国开展临床开发，为局部晚期转移性肝细胞癌患者提供联合治疗。

多中心，开放标签和多剂量1b / 2期研究将评估CS1001（一种抗PD-LI单克隆抗体）与BLU-554（一种有效且高选择性的成纤维细胞生长因子受体抑制剂4）的安全性，耐受性和疗效。 （FGFR4）。
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“新兴的临床数据显示，通过将免疫疗法与作为单一药物活跃的靶向疗法相结合，HCC取得了令人鼓舞的结果，”CStone首席翻译医学博士Archie Tse博士在发布会上表示。 “CS1001和BLU -554的结合表明了这种方法的一个很好的例子，并为具有FGF19-FGFR4激活的晚期HCC提供了潜在的一线治疗策略。我们将迅速推进该计划的临床开发，以进一步探索这两个有希望的候选药物合并。“

CS1001也正在研究用于治疗肺癌和胃癌。 1a期数据显示CS1001耐受性良好且经证实具有抗肿瘤活性。

BLU-554在第1阶段研究中具有良好的耐受性和经验性的鼓励抗肿瘤活性，并且被FDA授予HCC的孤儿药物名称。

“CStone的使命之一就是开发新疗法，以解决中国高度流行和难以治疗的癌症所造成的重要未满足需求。联合疗法和精准医学是我们管道的核心策略，”Frank Jiang，医学博士，博士， CStone董事长兼首席执行官在发布会上表示。 “我们预计BLU-554与CS1001的结合可为这一具有挑战性的疾病提供重要的额外治疗选择。”

参考：www.cstonepharma.com