FDA授予Tecentriq-Avastin组合突破性治疗肝癌的称号

StephenW

FDA grants Tecentriq-Avastin combination breakthrough therapy designation for liver cancer
July 18, 2018

The FDA granted breakthrough therapy designation to atezolizumab in combination with bevacizumab as a first-line treatment for patients with advanced metastatic hepatocellular carcinoma.

The FDA based this designation on results from a phase 1b study that evaluated atezolizumab (Tecentriq, Genentech), an anti-PD-L1 therapy, and bevacizumab (Avastin, Genentech), an anti-VEGF therapy, among patients with hepatocellular carcinoma.

Researchers presented data at ASCO Annual Meeting.

Results showed that among 23 efficacy-evaluable patients, 65% demonstrated responses after a median follow-up of 10.3 months. Researchers observed responses in all subgroups, including those based on the etiology of the patient’s disease, region, baseline alpha-fetoprotein levels or spread of tumor beyond the liver.

Median PFS, duration of response, time to progression and OS had not yet been reached.

Among 43 safety-evaluable patients, 28% experienced a grade 3 or grade 4 treatment related-adverse events. Researchers did not observe any grade 5 adverse events nor any new safety signals beyond the established safety profiles of the individual medicines.

“Hepatocellular carcinoma is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide,” Sandra Horning, MD, chief medical officer and head of global product development at Roche, said in a press release. “Preliminary data from the combination of Tecentriq and Avastin in this disease are promising and we look forward to working with health authorities to make this potential treatment regimen available to people with hepatocellular carcinoma as soon as possible.”

Enrollment is ongoing for a phase 3 study of atezolizumab plus bevacizumab compared with sorafenib (Nexavar, Bayer) among patients with previously untreated unresectable or metastatic hepatocellular carcinoma.

StephenW

FDA授予Tecentriq-Avastin组合突破性治疗肝癌的称号
2018年7月18日

美国食品和药物管理局授予atezolizumab突破性治疗名称与贝伐单抗联合作为晚期转移性肝细胞癌患者的一线治疗。

美国食品和药物管理局根据1b期研究的结果提出这一观点，该研究评估了atezolizumab（Tecentriq，Genentech），一种抗PD-L1疗法，以及bevacizumab（Avastin，Genentech），一种抗VEGF疗法，用于肝细胞癌患者。

研究人员在ASCO年会上提交了数据。

结果显示，在23名疗效评估的患者中，65％的患者在中位随访10.3个月后表现出反应。研究人员观察了所有亚组的反应，包括基于患者病因，区域，基线甲胎蛋白水平或肝脏外肿瘤扩散的病因。

尚未达到中位PFS，反应持续时间，进展时间和OS。

在43名安全性评估患者中，28％经历了3级或4级治疗相关不良事件。研究人员未观察到任何5级不良事件，也未发现任何超出单个药物安全概况的新安全信号。

“肝细胞癌是一种侵袭性癌症，治疗方案有限且是全球癌症死亡的主要原因，”罗氏首席医疗官兼全球产品开发负责人Sandra Horning在一份新闻稿中表示。 “Tecentriq和Avastin联合治疗这种疾病的初步数据很有希望，我们期待与卫生当局合作，尽快为肝细胞癌患者提供这种潜在的治疗方案。”

在先前未治疗的不可切除或转移性肝细胞癌患者中，与索拉非尼（Nexavar，Bayer）相比，atezolizumab加bevacizumab的3期研究正在进行入组。