Merck's Cancer Immunotherapy Keytruda Continues to Aid Growth

分析称Keytruda研发和销售进展顺利,将推动默沙东公司业绩持续向好

2019-08-16 14:06:00 Zacks

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The demand for checkpoint inhibitors, especially those targeting PD-1 and PD-L1, has risen significantly in the past couple of years. Cancer therapies that target either PD-1 or PD-L1 can stop them from attaching and prevent cancer cells from hiding. PD-L1 inhibitors available on the market are Merck’s MRK Keytruda, AstraZeneca’s AZN Imfinzi, Bristol Myers’ BMY Opdivo, Roche’s Tecentriq and Pfizer’s PFE Bavencio. Keytruda continues to be a key contributor to Merck’s sales. In a short span of time, Keytruda has become Merck’s biggest product. It is now already approved for use in 20 indications across 12 different tumor types in the United States. The drug generated sales of almost $5.0 billion in the first half of 2019, reflecting a massive 56.6% surge year over year. Keytruda is continuously growing and expanding into new indications and markets globally. Keytruda sales are gaining from strong momentum in first-line lung cancer indication and recent launch in newer indications – renal cell carcinoma and adjuvant melanoma. The Keytruda development program is also progressing well with Merck spending billions for research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in more than 1000 studies, including more than 600 combination studies. Merck is collaborating with several companies including Amgen, Incyte, Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.  This year so far, Keytruda has gained several label expansion approvals. In July, Keytruda was approved by the FDA as a monotherapy for advanced esophageal cancer. In June, it was approved by the FDA for first-line treatment of recurrent or metastatic HNSCC and for previously treated advanced small-cell lung cancer. In April, the FDA gave approval to Keytruda in combination with Pfizer’s Inlyta for the first-line treatment of advanced renal cell carcinoma as well as for an expanded first-line lung cancer patient population. In the first quarter, it was approved by the FDA as an adjuvant therapy for high-risk stage III melanoma and for five new cancer line extensions in Japan. All these label expansion approvals should drive sales of Keytruda higher in the future quarters. Several regulatory decisions for new indications in the United States as well as in Europe are pending in the rest of the year, which if approved can further boost sales.  Though Keytruda has its share of side effects and has suffered some major pipeline setbacks, we believe the drug has strong growth prospects based on increased utilization, recent approvals for new indications and potential additional approvals worldwide.
对检查点抑制剂的需求,特别是针对 PD-1和 PD-L1的需求,在过去几年中已经显著增加。针对 PD-1或 PD-L1的癌症治疗可以阻止它们附着并防止癌细胞隐藏。 市场上可用的 PD-L1抑制剂有默克(Merck)的 MRK 可瑞达(Keytruda)、阿斯利康(AstraZeneca)的 AZN Imfinzi 、百时美施贵宝的 BMY Opdivo 、罗氏(Roche)的 Tecentriq 和辉瑞(Pfizer)的 PFE Bavencio 。 可瑞达(Keytruda)仍是默克(Merck)销售的关键贡献者。在短时间内,可瑞达(Keytruda)已成为默克(Merck)的最大产品。它现在已经被批准用于20个适应症横跨12种不同的肿瘤类型在美国。该药物在2019年上半年的销售额接近50亿美元,同比大幅增长56.6%。 可瑞达(Keytruda)在全球范围内不断发展和拓展新的适应症和市场。可瑞达(Keytruda)的销售正从一线肺癌适应症的强劲势头以及近期新适应症——肾细胞癌和辅助黑色素瘤——的推出中获益。 可瑞达(Keytruda)开发计划也进展顺利,默克(Merck)公司花费数十亿美元用于该药物的研发,以确保在早期治疗中获得更多的批准。在1000多项研究中,该药物正在研究30多种癌症,其中包括600多项联合研究。默克(Merck)公司正在与安进(Amgen)、因塞特(Incyte)、葛兰素、辉瑞(Pfizer)等多家公司分别合作,联合其他方案对可瑞达(Keytruda)进行评估。 今年到目前为止,可瑞达(Keytruda)已获得多项标签扩展批准。7月,可瑞达(Keytruda)被 FDA 批准为晚期食管癌的单一疗法。今年6月, FDA 批准该药物用于复发或转移的 HNSCC 一线治疗以及先前治疗的晚期小细胞肺癌。今年4月, FDA 批准可瑞达(Keytruda)与辉瑞(Pfizer)的 Inyta 联合应用于晚期肾细胞癌的一线治疗以及扩大一线肺癌患者数量。在第一季度,它被批准作为一种辅助治疗高风险的 III 期黑色素瘤和五个新的癌症扩展在日本。所有这些标签扩展审批应推动可瑞达(Keytruda)在未来几个季度的销售增长。 美国和欧洲的一些新适应症的监管决定将在今年余下的时间内做出,如果获得批准,这将进一步促进销售。 虽然可瑞达(Keytruda)具有一定的副作用,并遭受了一些重大的管道挫折,但我们相信该药物具有强劲的增长前景,其基础是更多的利用,最近批准的新适应症和潜在的全球额外批准。

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