Merck's Keytruda dispels 'urban legend' around lung efficacy


2019-09-11 15:00:00 pharma


Merck’s Keytruda-chemo combo has a history of silencing its critics when it comes to its effectiveness in previously untreated non-small cell lung cancer patients. And it may have just done it again. A pooled analysis from three trials showed that the combo majorly cut patients’ risk of death, even among those whose tumors tested negative for PD-L1. That biomarker has in some indications been linked to better performances for Keytruda and its classmates.    “There is this notion out there that somehow chemo combo is less effective with PD-L1 negatives, and frankly the data just don’t support that at all,” Roy Baynes, M.D., Merck SVP and head of global clinical development, said. “… This is really setting the record straight around the fact that in the chemo combo setting, biomarker selection does not affect the outcome.” In 428 PD-L1-negative patients, Keytruda and chemo slashed the risk of death by 44% compared with chemo alone. 46.9% of patients in that group responded to treatment, versus just 28.6% of the chemo group. Those numbers mirror figures from the broader population of participants in the three individual studies— Keynote-189, Keynote-407 and Keynote-021’s Cohort G. Baynes said he has “no idea” where the idea that the combo performed weaker among PD-L1-negative patients came from, but “it’s a sort of urban legend that I confront on a regular basis,” he said. That may change after Merck’s presentation of the analysis, which happened Tuesday at the World Conference on Lung Cancer in Barcelona. It wouldn’t be the first time new data put Keytruda’s doubters in their place. Before Keynote-189 results confirmed that the Keytruda-chemo duo could cut patients’ risk of death by half, investors feared the benefits seen in the phase 2 Keynote-021 could have been a fluke. It wasn’t until Merck unveiled its mammoth survival win that they put what Evercore ISI analyst Umer Raffat called “conspiracy theories” to rest. Since then, Keytruda uptake in the front-line setting has skyrocketed, and the latest analysis will only provide more sales firepower. In Q2, the blockbuster generated $2.63 billion globally, with U.S. sales jumping by 73% over the year-ago period.
默克公司( Merck )的 Keytruda-Chemical combo 在之前未经治疗的非小细胞肺癌患者中的有效性问题上一直在让批评者沉默。也许它又做了一次。 三个试验的综合分析表明,这种联合疗法极大地降低了患者的死亡风险,即使在那些肿瘤被检测为 PD-L1阴性的患者中也是如此。这种生物标记在某些方面与可瑞达(Keytruda)及其同班同学更好的表现有关。 “有一种观点认为,某种程度上,化学组合对 PD-L1阴性药物的疗效较差,坦率地说,数据根本不支持这种观点,”罗伊贝恩斯,医学博士(M.D.)博士,默克(Merck)公司 SVP 和全球临床开发负责人说。“……事实上,在化学组合中,生物标记的选择并不影响结果。” 在428名 PD-L1阴性患者中,可瑞达(Keytruda)和 Chem 将死亡风险与单纯化疗相比降低了44%。46.9%的患者对治疗有反应,而化疗组仅为28.6%。 这些数字反映了三个个体研究参与者中更广泛人群的数据—— Keynote-189、 Keynote-407和 Keynote-021的 Cohort G.Baynes 说,他“不知道”在 PD-L1阴性患者中,这种组合表现较弱的观点来自哪里,但“这是我经常面对的一种城市传说。”他说。 在默克(Merck)公司周二在巴塞罗那举行的肺癌世界会议上公布了这一分析之后,情况可能会发生变化。这将不是第一次新数据取代可瑞达(Keytruda)的怀疑者。 在 Keynote-189的结果证实 Keytruda-Chemical 这两个药物可以将患者的死亡风险降低一半之前,投资者担心在第二阶段 Keynote-021中看到的好处可能是侥幸。直到默克公司( Merck )公布了其庞大的生存胜利后,他们才把 Evercore ISI 分析师 Umer Rafat 所称的“阴谋理论”搁置一旁。 从那时起,可瑞达(Keytruda)在一线环境中的应用急剧增长,最新的分析只会提供更多的销售火力。在第二季度,这一重磅炸弹在全球创造了26.3亿美元,美国销售额比去年同期增长了73%。