FDA Gives Merck's Keytruda Thumbs-Up for Two More Indications

FDA 给默克(Merck)公司的可瑞达(Keytruda) Thumbs-up 增加两个适应症

2019-06-11 22:25:48 BioSpace


JHVEPhoto / Shutterstock The U.S. Food and Drug Administration (FDA) approved Merck’s checkpoint inhibitor Keytruda (pembrolizumab) for two more indications: as a monotherapy in PD-L1 expressing tumors or in combination with platinum and fluorouracil (FU), a chemotherapy treatment, for first-line metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). The approval was built on data from the Phase III KEYNOTE-048 clinical trial. In it, Keytruda showed improvement in overall survival (OS) compared with the EXTREME regimen, which is cetuximab with carboplatin or cisplatin plus FU. Patients in this group had PD-L1 expression of equal to or greater than CPS 1. It was also evaluated in combination with chemotherapy in the total study population. “This approval is a very exciting milestone in the treatment of head and neck cancer and has the potential to transform the way we treat patients with this debilitating disease by offering important new therapeutic options,” stated Barbara Burtness, professor of medicine at Yale School of Medicine and co-director of the Development Therapeutics Research Program at Yale Cancer Center. Burtness went on to note, “Metastatic or recurrent head and neck cancer has been an area of significant unmet need, so it is encouraging to have immunotherapy regimens available for patients in the first-line setting.” Keytruda is the leading checkpoint inhibitor on the market and in many ways is as close to a miracle cancer drug as any that exists currently. But it is also something Merck is very reliant upon. In the first quarter of this year, Keytruda made up 21% of Merck’s sales, and is expected to increase. Max Nisen, writing for Bloomberg, notes, “The problem is, the company has a lot of slower-growing older drugs and something of a dearth of newer products. Keytruda also gobbles up an outsize portion of Merck’s hefty R&D budget as the company works to expand its use.” Yesterday, Merck announced it was acquiring Lexington, Mass.-based Tilos Therapeutics in a deal that could hit $773 million. Tilos is focused on developing drugs that target the latency-associated peptide (LAP)-TGF beta complex, which is involved in the immune system. It has implications for cancer, fibrosis and autoimmune diseases. hbspt.cta.load(4413123, '404ba7a7-73a5-4877-8e77-f29b5ce4a0f2', {}); It is the third cancer-focused deal Merck has made recently. It bought Immune Design in February for $300 million and Peloton Therapeutics for $2.2 billion in May. Merck’s focus on Keytruda, which is involved in more than 1,000 clinical trials by the company and with partner companies, has been effective so far. However, there are five similar drugs on the market with more likely to be approved. Nisen reports that Chinese drug companies are currently selling competing drugs at a lower price with an intention to push into the broader global market. BioSpace recently interviewed Scot Ebbinghaus, Merck Research Laboratories’ Vice President and Therapeutic Area Head, Oncology Clinical Research. Although the recent acquisitions do indicate the company wants to expand past Keytruda, Ebbinghaus shared the company’s plans for future Keytruda development. The first, he says, is to further evaluate and improve on the foundation they’ve laid with Keytruda in the company’s combination program. “We have a very large program to evaluate combinations and signal-finding and have collaborated with a number of industry partners to do signal-finding in a variety of combinations and a variety of diseases. A number of those are starting to show interesting results and we’re moving into registration development.” The second pathway is to evaluate Keytruda in earlier stages of the disease. As Ebbinghaus points out, the trials discussed so far have been in cancer that has metastasized. “What we would like to do,” he says, “is use Keytruda in an earlier setting, for example after cancer surgery, to reduce the risk of cancer coming back.”
JHVAEPhoto / Shutterstock 美国食品药品监督管理局(Food and Drug Administration)( FDA )批准默克(Merck)公司的检查点抑制剂可瑞达(Keytruda)( pembrolizumab )有两个更多的适应症:作为 PD-L1表达肿瘤的单一疗法,或与铂和氟尿嘧啶( FU )联合化疗,用于一线转移或不能切除。头颈部鳞癌复发。 批准建立在 III 期 KEYNOTE-048临床试验的数据基础上。与 ExTREME 养生法相比,可瑞达(Keytruda)显示整体生存( OS )有所改善,即西妥昔单抗与卡铂或顺铂加 FU 。这组患者的 PD-L1表达等于或大于 CPS1。在整个研究人群中,还结合化疗进行了评估。 “这一批准是治疗头颈癌的一个非常令人兴奋的里程碑,通过提供重要的新治疗方案,有可能改变我们治疗这种衰弱疾病的方式。”耶鲁大学医学院医学教授,耶鲁大学癌症中心发展治疗研究项目联合主任。 Burcht 接着指出,“转移性或复发性头颈癌一直是一个未得到满足的重要领域,因此在一线环境下为患者提供免疫治疗方案是令人鼓舞的。” 可瑞达(Keytruda)是市场上领先的检查点抑制剂,在许多方面与目前存在的任何一种癌症药物一样接近一种奇迹药物。但这也是默克(Merck)公司非常依赖的东西。今年第一季度,可瑞达(Keytruda)占默克(Merck)公司销售额的21%,预计将有所增长。 为彭博撰稿的马克斯•尼森( Max Nisen )指出:“问题在于,该公司有很多增长较慢的老药品,以及一些缺乏新产品的产品。随着默克公司努力扩大其用途,可瑞达(Keytruda)也吞下了默克(Merck)巨额研发预算中的一大部分。” 昨天,默克(Merck)宣布收购马萨诸塞州列克星敦。- Tilos Therapeutics 的交易可能达到7.73亿美元。Tilos 致力于开发针对潜伏期相关多肽( LAP )-TGF β复合物的药物,该复合物涉及免疫系统。它对癌症、纤维化和自身免疫性疾病有影响。 。cta 。负载(443123,'4044a7a7-73a5-4877-8e77-f29b5ce4a0f2',{}); 这是默克(Merck)公司最近达成的第三笔以癌症为重点的交易。今年2月,该公司以3亿美元收购了 Immune Design ,5月份以22亿美元收购了 Peloton Therapeutics 。 默克(Merck)公司对可瑞达(Keytruda)的关注,涉及到公司和合作伙伴公司进行的1000多项临床试验,目前已经生效。然而,市场上有五种类似药物更有可能获得批准。Nisen 报告称,中国药企目前正以较低的价格销售竞争药物,目的是进军更广泛的全球市场。 Biospace 最近采访了默克(Merck)研究实验室副总裁兼肿瘤临床研究治疗区负责人 Scot Ebbinghus 。虽然最近的收购确实表明,该公司希望扩大过去的 Keytruda ,但 Ebbinghus 分享了该公司的未来可瑞达(Keytruda)发展计划。 他说,第一个是在他们与可瑞达(Keytruda)合作的基础上,进一步评估和改进公司的联合项目。“我们有一个非常大的程序来评估组合和信号发现,并与许多行业合作伙伴合作,在各种组合和多种疾病中进行信号发现。其中很多已经开始显示出有趣的结果,我们正在进入注册开发阶段。” 第二个途径是评价可瑞达(Keytruda)在早期阶段的疾病。正如 Ebbinghus 指出的那样,迄今为止讨论的试验都是在癌症中转移的。“我们想做的是,”他说,“在更早的环境中使用可瑞达(Keytruda),例如在癌症手术后,以降低癌症复发的风险。”