Pemetrexed Disodium Hydrate

Merck & Co – known as MSD outside the US and Canada – has received approval from the US Food and Drug Administration (FDA) for the use of Keytruda (pembrolizumab) in malignant pleural mesothelioma. The anti-PD-1 therapy has been approved in combination with pemetrexed and platinum chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic cases of the disease. More than 30,000 new cases of mesothelioma, a type of cancer that starts in the linings of certain parts of the body, were diagnosed globally in 2022. Pleural mesothelioma, which develops in the lining of the lungs, accounts for approximately 75% of all malignant mesothelioma cases and can progress rapidly. The FDA’s decision was supported by positive results from the phase 2/3 IND.227/KEYNOTE-483 trial, in which Keytruda plus chemotherapy reduced the risk of death by 21% compared to chemotherapy alone. Median overall survival was 17.3 months for Keytruda plus chemotherapy compared to 16.1 months for chemotherapy alone, and the combination also demonstrated significant improvements in progression-free survival and overall response rate. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories, said: “We’re pleased to offer a new first-line treatment option for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, a disease where prognoses are generally poor.” Merck’s Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumour cells, and is already approved in the US for a range of indications, including for certain cases of breast, lung and bladder cancer. The latest authorisation comes just three months after the company received expanded approval from the FDA for a Keytruda/carboplatin and paclitaxel regimen in primary advanced or recurrent endometrial carcinoma. The drug was also approved by the US regulator in January for use alongside chemoradiotherapy to treat newly-diagnosed cervical cancer patients with stage 3 to 4a disease. There are currently more than 1,600 trials studying the therapy, including one evaluating it in combination with Merck and Moderna’s investigational skin cancer vaccine .

▎药明康德内容团队编辑 默沙东（MSD）今日宣布，美国FDA已批准其重磅PD-1抑制剂Keytruda（pembrolizumab）与培美曲塞和铂类化疗联合，作为一线疗法治疗不可切除的晚期或转移性恶性胸膜间皮瘤（MPM）成年患者。 恶性间皮瘤是一类起源于身体某些部位内壁的癌症，可能源自于胸部、腹部、心脏和睾丸。据预估在2022年，全世界恶性间皮瘤新确诊病例超过3万，死于该疾病人数超过2.5万。胸膜间皮瘤发生于肺内壁，是恶性间皮瘤中最常见的一种，约占所有病例的75%。恶性胸膜间皮瘤往往进展迅速，五年生存率仅为12.8%。持续使用和暴露于石棉之下是导致这种侵袭性肿瘤全球发病率不断增加的原因之一。 此项批准主要基于关键2/3期IND.227/KEYNOTE-483试验的数据。在该试验中，Keytruda联合化疗在统计学上显著改善患者的总生存率。在试验预定的最终分析中，与仅接受化疗的患者相比，Keytruda联合化疗组患者的死亡风险降低了21%（HR=0.79，95% CI：0.64-0.98，p=0.0162）。Keytruda联合化疗组患者的中位总生存期（OS）为17.3个月（95% CI：14.4-21.3），而化疗组患者的中位OS为16.1个月（95% CI：13.1-18.2）。 Keytruda联合化疗在无进展生存期（PFS）方面也显示出显著改善（HR=0.80，95% CI：0.65-0.99，p=0.0194）。Keytruda联合化疗组患者的总缓解率（ORR）也显著高于化疗组（p<0.00001），两组的ORR分别为52%（95% CI：45.5-59.0）与29%（95% CI：23.0-35.4）。在这项研究中，Keytruda联合化疗的安全性特征与之前报告的结果一致。 Keytruda是默沙东开发的PD-1抑制剂，可阻断PD-1与其配体PD-L1和PD-L2之间的相互作用，释放PD-1信号通路介导的免疫反应抑制，从而激活可能影响肿瘤细胞和健康细胞的T淋巴细胞，进而增强人体免疫系统发现和消灭癌细胞的能力。自在2014年首次获得FDA批准治疗晚期黑色素瘤以来，Keytruda已经获得FDA批准，治疗至少16种癌症类型，以及不限癌种的适应症。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Pemetrexed and Platinum Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma (MPM). Retrieved September 18, 2024 from https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-plus-pemetrexed-and-platinum-chemotherapy-as-first-line-treatment-for-adult-patients-with-unresectable-advanced-or-metastatic-malignant-pleu/ 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新