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肝胆相照论坛 论坛 肝癌,肝移植 首例患者在晚期HCC治疗的2/3期试验中给药 ...
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[晚期肝癌] 首例患者在晚期HCC治疗的2/3期试验中给药 [复制链接]

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发表于 2019-3-4 21:43 |只看该作者 |倒序浏览 |打印

First patient dosed in phase 2/3 trial of advanced HCC therapy
March 3, 2019

Innovent Biologics announced first patient dosing in a phase 2/3 trial of Tyvyt with IBI305 for patients with advanced hepatocellular carcinoma taking place in China, according to a press release.

"HCC is the fourth most common cancer and the second leading cause of cancer related death in China,” Fan Jia, president of Zhongshan Hospital, said in the release. “The five-year survival rate is about 10%, and only 20-30% of patients have the opportunity for curative surgery. Current targeted therapies have only shown limited responses in HCC. Immune checkpoint inhibitors have brought new hope to patients with this life-threatening disease.”

Tyvyt (sintilimab injection) is a fully human anti-programmed cell death protein 1 monocloncal antibody. IBI305 is recombinant humanized anti-vascular endothelial growth factor monoclonal antibody.

The randomized control ORIENT-32 study will include 566 patients with advanced HCC. Results from the trial will be compared with Nexavar (sorafenib, Bayer) for safety and efficacy.

“The development of new agents for the treatment of advanced HCC has been stagnant, so there is a huge unmet clinical need,” Michael Yu, founder, CEO and chairman of Innovent, said in the release. “Based on the encouraging data we have observed in our phase Ib study, we have decided to conduct the ORIENT-32 trial. We seek to discover, develop, and commercialize products that provide more effective cancer treatment to help our patients and their families.”

Reference: www.innoventbio.com

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发表于 2019-3-4 21:43 |只看该作者
首例患者在晚期HCC治疗的2/3期试验中给药
2019年3月3日

根据一份新闻稿,Innovent Biologics宣布首次在Tyvyt和IBI305的2/3期试验中对患有晚期肝细胞癌的患者进行治疗。

中山医院院长范佳在发布会上说:“HCC是中国第四大常见癌症,也是中国癌症相关死亡的第二大原因。”五年生存率约为10%,只有20- 30%的患者有机会进行治愈性手术。目前的靶向治疗仅显示HCC的反应有限。免疫检查点抑制剂为患有这种危及生命的疾病的患者带来了新的希望。“

Tyvyt(sintilimab注射液)是一种完全人类抗程序性细胞死亡蛋白1单克隆抗体。 IBI305是重组人源化抗血管内皮生长因子单克隆抗体。

随机对照ORIENT-32研究将包括566例晚期HCC患者。试验结果将与多吉美(索拉非尼,拜耳)进行比较,以确保安全性和有效性。

“用于治疗晚期HCC的新药物的开发一直停滞不前,因此临床需求尚未得到满足,”Innovent创始人,首席执行官兼董事长Michael Yu在发布会上表示。 “根据我们在Ib期研究中观察到的令人鼓舞的数据,我们决定进行ORIENT-32试验。我们致力于发现,开发和商业化提供更有效的癌症治疗的产品,以帮助我们的患者及其家人。“

参考:www.innoventbio.com
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