Opdivo spurs fivefold increase in lung cancer survival

百时美施贵宝公布数据,Opdivo治疗非小细胞肺癌,患者生存率较化疗提高5倍多

2019-09-11 14:00:00 pharma

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Bristol-Myers Squibb has been looking to preserve Opdivo’s share of the non-small cell lung cancer market with long-term survival data. And Tuesday, it came out with immuno-oncology's longest-term data yet. At the five-year mark, use of Opdivo in previously treated NSCLC patients delivered survival rates more than five times as high as docetaxel chemotherapy did, BMS said at the World Conference on Lung Cancer in Barcelona. More than 13% of those treated with Opdivo were still alive five years after treatment began, versus just 2.6% of docetaxel patients. And among patients who responded to Opdivo, 32.2% were still responding at that point. Opdivo-treated patients responded for a median 19.9 months, compared with 5.6 months for those in the docetaxel arm. In other words, “one out of three patients who responds” to Opdivo is “still responding at five years,” Sabine Maier, M.D., the company’s development lead for thoracic cancers, noted. Those results sit in stark contrast with the “very transient benefit” that chemo offers. “What’s exciting is if you make it to two or three years, you actually have a very high chance of also making it progression-free to five years,” she said. And that stat “gives us hope that by using I-O in different settings, we could be seeing similar plateaus.” The analysis pooled results from two of the New Jersey drugmaker’s phase 3 trials, known as CheckMate-017 and CheckMate-057. Between those two studies, BMS started with a hefty sample size of more than 850 patients, so “we can very well characterize” Opdivo’s impact, Maier said. The pooling also allowed BMS to examine Opdivo’s effects on subgroups, and Maier flagged a “substantial increase in survival” even in those patients whose tumors tested negative for biomarker PD-L1. Bristol is hoping the new results will help it hold onto share in a market that’s steadily shrinking, thanks in no small part to rival Merck & Co. Ever since the Big Pharma’s Keytruda-chemo combo showed it could cut death risks by half in previously untreated NSCLC patients, use of the drug in the front-line setting has skyrocketed—reducing the number of patients eligible to receive Opdivo and Yervoy. And given that BMS still doesn’t have its own I-O regimen approved for newly diagnosed patients, it needs those second-line lung cancer sales. New competition is pressuring Opdivo in other key areas such as kidney cancer, and a recent spate of trial failures hasn’t helped sales prospects, either.
百时美施贵宝一直在寻求通过长期生存数据来保持 Opdivo 在非小细胞肺癌市场的份额。周二,它公布了免疫肿瘤学最长的数据。 百时美施贵宝(BMS)在巴塞罗那肺癌世界会议上说,在过去接受治疗的非小细胞非小细胞肺癌(NSCLC)患者中,使用 Opdivo 的生存率是多西他赛化疗的5倍多。在接受 Opdivo 治疗的患者中,超过13%的人在治疗开始五年后仍然存活,而在多西他赛患者中只有2.6%。 在对 Opdivo 做出反应的患者中,有32.2%的人在这一点上仍有反应。接受 Opdivo 治疗的患者中位数为19.9个月,而多西他赛手臂的患者中位数为5.6个月。 换句话说,“在对 Opdivo 做出反应的三名患者中,有一名“仍在五年内作出反应”, Sabine Maier 医学博士(M.D.)博士指出,他是该公司胸腔癌的发展领导者。这些结果与化疗提供的“非常短暂的益处”形成鲜明对比。 “令人兴奋的是,如果你把它变成两到三年,你实际上有很高的机会让它也可以发展到五年。”“通过在不同的环境中使用 I-O ,我们可以看到类似的高原。” 该分析汇总了新泽西制药商三期试验的两个结果,即 CheckMate-017和 CheckMate-057。Maier 说,在这两项研究中,百时美施贵宝(BMS)首先对850多名患者进行了大量抽样调查,因此“我们可以很好地描述” Opdivo 的影响。 这一联合研究还使百时美施贵宝(BMS)能够检查 Opdivo 对亚组的影响, Maier 甚至在那些肿瘤被检测为 PD-L1阴性的患者中也指出了“生存的实质性增加”。 Bristol 希望新的结果能帮助它在这个正在稳步萎缩的市场上保持份额,这在很大程度上要归功于竞争对手默克(Merck)公司。自从大型制药公司 Keytruda-Chemical combo 显示它可以将非小细胞非小细胞肺癌(NSCLC)患者的死亡风险降低一半。在一线环境中使用这种药物的人数急剧上升,从而减少了有资格接受 Opdivo 和 Yervoy 治疗的病人数量。 鉴于百时美施贵宝(BMS)还没有自己的 I-O 养生法被批准用于新诊断的患者,它需要那些二线肺癌的销售。新的竞争给 Opdivo 在肾癌等其他关键领域带来了压力,最近一系列的试验失败也没有帮助销售前景。

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