在第二阶段的研究中，默克的Keytruda在超过16％的既往接受治

StephenW

Merck's Keytruda makes liver-cancer headway, putting BMS and Bayer on notice
by Carly Helfand | Jan 23, 2018 10:20am
Keytruda
Merck's Keytruda provoked a response in more than 16% of previously treated liver cancer patients in a phase 2 study. (Merck)

Kidney cancer isn’t the only disease area where Merck’s Keytruda is moving in to challenge Bristol-Myers Squibb’s Opdivo.

At the American Society of Clinical Oncology’s GI Cancers Symposium Friday, Merck rolled out phase 2 liver cancer data that could advance it into that arena, too. The immuno-oncology superstar produced a response in 16.3% of study patients with hepatocellular carcinoma (HCC)—the most common form of liver cancer—who had been previously treated with Bayer’s Nexavar. In 1% of patients, no trace of cancer remained after treatment.

While a 16.3% response rate doesn’t sound all that impressive, it’s not much lower than the rate Opdivo posted on its way to its September liver cancer approval. The BMS drug put up an 18.2% overall response rate in a phase 1/2 study, with 3.2% of patients responding completely.

RELATED: With Stivarga-Nexavar bridge-building complete in liver cancer, Bayer gets ready to run the table

“Unfortunately, the majority of HCC patients are diagnosed with advanced-stage disease,” Adrian Bisceglie, chief of hepatology at the Saint Louis University Liver Center, said in a statement after Opdivo won its go-ahead. Andrew Zhu, lead investigator of the Keytruda study, noted that “the durable responses observed with Keytruda monotherapy in this difficult-to-treat cancer are encouraging.”

If Keytruda can eventually land a go-ahead in the field, it’ll face some stiff competition not just from its immuno-oncology nemesis Opdivo but from Bayer, which has dominated the liver cancer landscape for years with Nexavar. Last April, the German drugmaker picked up a nod for Stivarga—its follow-up to the older Nexavar—in previously treated liver cancer, and it’s working to position the pair of meds as a sequential regimen. That way, it can keep patients who fail on Nexavar in the family, rather than ceding them to other drugmakers.

RELATED: Merck, Eisai nab Keytruda-Lenvima 'breakthrough' in quickly crowding kidney cancer field

Meanwhile, Merck is also readying Keytruda to poach territory from Opdivo in kidney cancer, where Keytruda—along with Eisai’s Lenvima—earlier this month nabbed a breakthrough designation from the FDA. It’s not the only one, though. Roche and the Pfizer-Merck KGaA team are both in that race, too, with their IO drugs Tecentriq and Bavencio, respectively.
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StephenW

默克公司的Keytruda使得肝癌发生了进展，通知BMS和拜耳
通过Carly Helfand | 2018年1月23日上午10点20分
Keytruda
在第二阶段的研究中，默克的Keytruda在超过16％的既往接受治疗的肝癌患者中引发了反应。 （Merck）上
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肾癌不是唯一一个默克的Keytruda正在向Bristol-Myers Squibb的Opdivo挑战的疾病领域。

在周五举行的美国临床肿瘤学会消化癌研讨会上，默克公司推出了第二阶段的肝癌数据，可以推动其进入该领域。免疫肿瘤超级巨星在16.3％的肝细胞癌（HCC）研究患者中产生应答最常见的肝癌 - 之前曾接受拜耳的多吉美（Nexavar）治疗。在1％的患者中，治疗后没有留下任何癌症痕迹。

虽然16.3％的回应率听起来并不令人印象深刻，但并不比Opdivo在9月份获得肝癌批准的过程中发布的数字要低。 BMS药物在1/2期研究中总有效率为18.2％，3.2％的患者完全缓解。

相关：随着Stivarga-Nexavar桥梁建成完成在肝癌，拜耳准备运行表

圣路易斯大学肝脏中心肝病科主任Adrian Bisceglie在Opdivo获得批准后的一份声明中说：“不幸的是，大多数HCC患者被诊断为晚期疾病。 Keytruda研究的首席研究员Andrew Zhu指出：“鼓励在这种难以治疗的癌症中用Keytruda单一疗法观察到的持久反应。”

如果Keytruda最终能在这个领域取得进展，它将面临一些激烈的竞争，不仅仅是来自Opdivo的免疫肿瘤克星，而且还有多年来一直用Nexavar控制肝癌风险的拜耳。去年四月，这位德国制药商在之前接受治疗的肝癌患者中接受了针对早期多吉美治疗的Stivarga的后续行动，并且正在努力将这两种药物定位为顺序疗法。这样，就可以让那些在多吉美失败的患者留在家中，而不是把他们交给其他的制药商。

相关：Merck，Eisai nab Keytruda-Lenvima在快速拥挤肾癌领域的“突破”

与此同时，默克公司也准备要求Keytruda从Opdivo那里挖走肾癌领域，本月早些时候，Keytruda与卫材的Lenvima一起取得了FDA的突破性称号。这不是唯一的。罗氏公司和辉瑞公司的默克公司团队也分别在他们的竞争对手IO药物Tecentriq和Bavencio。
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