制药巨头施贵宝公司在2015年可谓是迎来一个开门红。公司开发的抗癌免疫疗法药物nivolumab在上个月获批以Opdivo的商品名上市。2015年的第一个月Opdivo又传来佳音，在施贵宝公司进行的一项肺癌对比临床研究中，Opdivo又斩获新的积极研究数据。在这项有272名肺癌患者参与的临床研究中，研究人员将Opdivo的疗效与目前临床上的标准疗法多西紫杉醇进行对比研究，结果证明了这种药物在患者总体存活率上的明显优势，达到了此前研究人员预期的首要实验终点。
Opdivo是时下研究最为火爆的PD-1药物，PD-1是一种细胞周期检验点蛋白，它的失控导致肿瘤细胞能够逃避体内免疫监控。根据FDA上月作出的决定，Opdivo被批准用于治疗黑色素瘤。而在这一领域中类似的药物还有默沙东的Keytruda。此次施贵宝的临床研究结果使得Opdivo成为第一个对肺癌有疗效的PD-1药物。更重要的是，这一结果将帮助施贵宝公司在PD-1药物研究领域中领先起竞争对手一步。目前活跃在这一领域的医药公司包括了默沙东、罗氏和阿斯利康等生物医药巨头。
施贵宝公司透露，公司已经向FDA和欧盟医药管理部门提交了Opdivo治疗肺癌适应症的申请。当然，雄心勃勃的施贵宝公司自然不会仅仅满足于肺癌、黑色素瘤两种疾病。事实上，施贵宝公司目前正在进行超过35项Opdivo单独或联合其他药物治疗不同肿瘤类型的研究。根据分析人士预计，Opdivo未来的销售额最高将达到50亿美元之多。
最近几年兴起的癌症免疫疗法研究为人类征服癌症这一疾病带来了新的希望，几乎所有的生物医药巨头都纷纷在这一领域运筹帷幄，希望能够分享一块蛋糕。但是，究竟谁能成为这场技术革命中的最大赢家，目前尚未可知。
Bristol-Myers Squibb Co Lung Cancer Drug Successful In Late-Stage TrialBristol-Myers Squibb Co (NYSE:BMY) announced yesterday that the Phase-III trial of its experimental lung-cancer treatment Opdivo has been terminated earlier-than-anticipated. The termination came after an independent monitoring committee concluded that the said drug had superior efficacy results, as compared to docetaxel, a chemotherapy drug used for treating lung cancer patients.
According to the independent data monitoring committee, the study accomplished its primary goal of showing a superior survival rate in comparison to docetaxel; the experimental drug yielded results that were better than the control arm. The committee made this announcement after an assessment in which Opdivo (Nivolumab) was evaluated against docetaxel in treating patients with advanced squamous cell Non-Small Cell Lung Cancer (NSCLC). A total of 272 patients had been tested in the open-label extension study.
Opdivo helps the body’s immune system in fighting cancer by obstructing the protein PD-1 (Programmed Death Receptor). Obstruction of this pathway is essential, otherwise cancer cells slip through without being detected by the immune system. For the first time, a PD-1 inhibitor has demonstrated a survival advantage in lung cancer. The company stated that health authorities will soon be provided with extensive trial result details.
Opdivo gained the US Food and Drug Administration’s (FDA) approval in 2014 for treating melanoma. Now, Bristol-Myers is seeking to have the drug label expanded to include its use in treating lung cancer; so far, the company is the only one to have developed a PD-1 inhibitor for this indication.
Many analysts believe that this therapy is promising. Due to a positive outlook, some analysts have even rated Bristol-Myers above AstraZeneca plc (ADR), Roche Holding Ltd. (ADR), and Merck & Co., Inc. Sales of the drug are expected to go up to $5 billion. Leerink Swann LLC stated that the treatment may go beyond $7 billion by 2020. Overall, the group of therapies (PD-1 and PD-L1) is estimated to result in annual revenues of around $35 billion.
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