Genentech的Tecentriq建立积极肝癌试验结果的动力

StephenW

Genentech's Tecentriq Builds Momentum with Positive Liver Cancer Trial Results                                                                                                                                        Published: Oct 21, 2019                                                                                                                                                                        
                                                                                                                By Mark Terry                                       
        
                                                                                
Genentech, a Roche company, announced that its Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) hit the mark on its Phase III IMbrave150 trial in unresectable hepatocellular carcinoma (HCC) patients who have not receive previous systemic therapy. In July 2018, the U.S. Food and Drug Administration (FDA) granted the combination in this patient population Breakthrough Therapy Designation based on results from an ongoing Phase Ib trial.
Hepatocellular carcinoma, a form of liver cancer, has been diagnosed in more than 42,000 people in the U.S. this year, and has tripled since 1980, with HCC responsible for 75% of all liver cancer cases in the U.S. HCC predominantly is the result of cirrhosis due to chronic hepatitis B and C or alcohol consumption. It tends to present at the advanced stage when treatment options are limited.
The trial met its co-primary endpoints, showing statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared to standard-of-care, Bayer’s Nexavar (sorafenib). Safety signals were consistent with those known for both Tecentriq and Avastin.
“We are very pleased with the results of our study testing the combination of Tecentriq and Avastin, which marks the first treatment in more than a decade to improve overall survival in people with unresectable hepatocellular carcinoma who have not received prior systemic therapy,” said Levi Garraway, chief medical officer and head of Global Product Development for Genentech.
Garraway went on to say, “HCC is a major cause of death globally and particularly in Asia, making this study an important step in our mission of addressing unmet medical needs for patients around the world. We will submit these data to global health authorities as soon as possible. Our hope is to bring a new treatment to people with this aggressive disease who currently have limited options.”
The company expects to submit to regulators in the U.S., Europe and China. The China market in particular is of interest to the company. Liver cancer is higher in China and may make up 50% of new cases globally each year. Roche’s sales in China have sped up this year, increasing more than 50% in the first three quarters of 2019.
Tecentriq’s revenue is growing, but it’s a late-comer to the checkpoint inhibitor market, falling significantly behind Merck’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab). Those two checkpoint inhibitors tend to be the first choice to treat more common cancers, such as non-small cell lung cancer. But Tecentriq is making forays into small targets like triple-negative breast cancer.
“This is an opportunity for Roche to continue its expansion in Asia, and especially in China,” Michael Nawrath, an analyst with Zuercher Kantonalbank, wrote in a note to investors.
IMbrave150 randomized 501 patients with unresectable HCC who hadn’t received previous systemic therapy. They were split 2:1 to receive the Tecentriq and Avastin combination or sorafenib. Both Tecentriq and Avastin were administered intravenously, whereas sorafenib is an oral medication. The patients in both arms received treatment until unacceptable toxicity or there was no longer any clinical benefit.

StephenW

Genentech的Tecentriq建立积极肝癌试验结果的动力

发表于：十月21，2019通过马克·特里

肝癌

罗氏公司Genentech宣布，其Tecentriq（atezolizumab）与Avastin（bevacizumab）的结合在其IMbrave150 III期临床试验中达到了不可切除的未接受过全身治疗的肝癌（HCC）患者的目标。 2018年7月，美国食品药品监督管理局（FDA）根据正在进行的Ib期临床试验的结果，将该组合授予了该患者人群突破性治疗指定称号。

肝细胞癌是一种肝癌，今年在美国已诊断出42,000多人，自1980年以来已增加了两倍，其中HCC占美国所有肝癌病例的75％HCC主要是肝硬化的结果由于慢性乙型和丙型肝炎或饮酒。当治疗选择受到限制时，它倾向于出现在晚期。

该试验达到了共同的主要终点，与医疗标准的拜耳Nexavar（sorafenib）相比，其总生存期（OS）和无进展生存期（PFS）在统计学上具有显着的临床意义，并且有意义。安全信号与Tecentriq和Avastin已知的信号一致。

利维说：“我们对Tecentriq和Avastin组合测试的研究结果感到非常满意，这标志着十多年来首次治疗可提高尚未接受过全身治疗的无法切除的肝细胞癌患者的总体生存率。” Genentech首席医学官兼全球产品开发主管Garraway。

Garraway继续说道：“ HCC是全球尤其是亚洲的主要死亡原因，这使这项研究迈出了我们为满足世界各地患者未满足的医疗需求而迈出的重要一步。我们将尽快将这些数据提交给全球卫生部门。我们希望为患有这种侵袭性疾病且目前选择有限的人带来新的治疗方法。”

该公司希望向美国，欧洲和中国的监管机构提交意见。公司特别关注中国市场。肝癌在中国较高，每年可能占全球新病例的50％。罗氏（Roche）在中国的销售额今年有所增长，在2019年前三个季度增长了50％以上。

Tecentriq的收入在增长，但在关卡抑制剂市场上却是后来者，大大落后于默克的Keytruda（pembrolizumab）和Bristol-Myers Squibb的Opdivo（nivolumab）。这两种检查点抑制剂往往是治疗更常见的癌症（例如非小细胞肺癌）的首选。但是，Tecentriq正在进军诸如三阴性乳腺癌之类的小目标。

Zuercher Kantonalbank的分析师Michael Nawrath在给投资者的一份报告中写道：“这为罗氏（Roche）继续在亚洲尤其是在中国扩张提供了机会。”

IMbrave150将501例先前未曾接受全身治疗的无法切除的HCC患者随机分组。他们按2：1比例接受Tecentriq和Avastin组合或索拉非尼。 Tecentriq和Avastin均静脉内给药，而索拉非尼是口服药物。双臂患者均接受治疗，直到出现无法接受的毒性反应或不再有任何临床益处为止。