FDA approves Merck, Eisai’s Keytruda and Lenvima combination for endometrial cancer

FDA批准Merck,Eisai的Keytruda和Lenvima联合治疗子宫内膜癌

2021-07-23 23:00:51 PHARMACEUTICAL

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Merck and Eisai have secured approval from the US Food and Drug Administration (FDA) for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination to treat patients with certain types of advanced endometrial carcinoma. This combination treatment is indicated for patients whose disease has progressed after systemic therapy in any setting and are not candidates for curative surgery or radiation. The FDA approval was based on data obtained from the Phase III KEYNOTE-775/Study 309 trial, where the combination of Keytruda and Lenvima significantly improved overall survival (OS) and progression-free survival (PFS), reducing the risk of death by 32% and the risk of disease progression or death by 40%. Additionally, the combination treatment has led to an objective response rate (ORR) of 30% versus 15% for patients receiving either doxorubicin or paclitaxel. Patients receiving Keytruda plus Lenvima treatment had a complete response rate of 5% compared with 3% for doxorubicin or paclitaxel, and a partial response rate of 25% versus 13%, respectively. Merck Research Laboratories Oncology Clinical Research vice-president Dr Gregory Lubiniecki said: “When compared to the chemotherapies used in this trial, this combination treatment regimen was proven to extend the lives of certain patients diagnosed with previously treated, advanced endometrial cancer. “Based on Phase III data, today’s approval acts as the confirmatory trial to our previous accelerated approval of Keytruda plus Lenvima in patients with certain types of advanced endometrial cancer and reinforces the impact of our joint research with Eisai in exploring the potential of this combination to treat more patients with challenging types of cancer.” Previously, the combination treatment was approved under the FDA’s accelerated approval process, Real-Time Oncology Review pilot programme and its Project Orbis initiative to treat certain endometrial cancer patients.
默克公司和艾赛公司已获得美国食品药品监督管理局(FDA)的批准,将Keytruda(彭布鲁利珠单抗)和Lenvima(lenvatinib)联合用于治疗某些类型的晚期子宫内膜癌患者。 这种联合治疗适用于在任何环境下系统治疗后病情进展且不适合治疗性手术或放疗的患者。 FDA的批准是基于III期KeyNote-775/Study 309试验获得的数据,在该试验中,Keytruda和Lenvima的组合显著提高了总存活率(OS)和无进展存活率(PFS),将死亡风险降低了32%,疾病进展或死亡风险降低了40%。 此外,联合治疗使接受阿霉素或紫杉醇治疗的患者的客观反应率(ORR)为30%而不是15%。 接受Keytruda和Lenvima治疗的患者完全有效率为5%,而阿霉素和紫杉醇的有效率为3%,部分有效率为25%和13%。 默克研究实验室肿瘤临床研究副总裁格雷戈里·卢比涅茨基博士说:“与这项试验中使用的化疗相比,这种联合治疗方案被证明可以延长某些被诊断患有以前治疗过的晚期子宫内膜癌的患者的生命。 “基于III期数据,今天的批准是对我们之前加速批准Keytruda加Lenvima用于某些类型晚期子宫内膜癌患者的确证试验,并加强了我们与Eisai联合研究的影响,探索这种组合治疗更多具有挑战性类型癌症患者的潜力。” 此前,联合治疗在FDA的加速批准程序、实时肿瘤学审查试点计划及其Orbis项目倡议下获得批准,用于治疗某些子宫内膜癌患者。

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