百时美施贵宝（BMS）3月4日表示，计划今年年底启动一项大型III期临床试验，以测试该公司2种备受瞩目免疫疗法（nivolumab和Yervoy）的组合疗法，是否能有效治疗肺癌。免疫疗法，能够增强免疫系统的抗癌能力。
该公司负责人在今年1月份称，还没有计划开展后期试验测试实验性抗癌单抗药nivolumab和另一种已获批的黑色素瘤治疗药物Yervoy的组合疗法，这吓坏了投资者。而本周二，BMS全球开发高级副总裁Brian Daniels，在波士顿Cowen和合作医疗会议上表示，该项III期临床试验已列入日程，将于2014年底启动，这一消息缓和了投资者的焦虑情绪。
BMP资本市场分析师Alex Arfaei称，从目前正在开展的II期试验来看，nivolumab+Yervoy免疫组合疗法想必具有持久疗效并改善患者生存，这使得百时美有信心将该组合疗法推进至昂贵的大型III期试验。
nivolumab属于新兴的PD-1抑制剂类药物，这类药物可阻断PD-1蛋白，从而使免疫系统能够识别并跟踪肿瘤细胞。研究人员认为，将PD-1抑制剂与其他免疫疗法联合用药，可能是未来癌症治疗的趋势。目前，默沙东（Merck & Co）和罗氏（Roche）均在开发类似的药物，如果获批，这些药物可能实现数十亿美元的年销售额。
然而，部分投资者认为，百时美谨慎的时间表，可能预示着nivolumab+Yervoy组合疗法用于肺癌治疗时缺乏协同（synergy）疗效。但Leerink Partners分析师在一份研究报告中称：“我们仍然认为，随着免疫肿瘤学（IO）组合疗法在黑色素瘤、肾癌、肺癌领域的推进，以及靶向肿瘤的新免疫疗法的出现，在未来12-18个月里，百时美施贵宝仍将保持其免疫肿瘤学的领导者地位。”
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癌细胞可能利用“调节子（regulator）”途径，如检查点（checkpoint）途径，逃避机体免疫系统，保护肿瘤免受免疫攻击。
Nivolumab是一种实验性、全人源化IgG4、抗程序性死亡受体1（PD-1）单克隆抗体，能够抑制PD-1与程序性死亡配体1（PD-L1/B7-H1）和程序性死亡配体2（PD-L2/B7-DC）的结合。阻断PD-1与其配体的相互作用，可能使T细胞恢复抗肿瘤免疫应答。目前，百时美施贵宝正调查nivolumab用于恶性黑色素瘤、肾癌、非小细胞肺癌及其他癌症的治疗。
nivolumab开发项目研究总数超过25个：调查作为单药疗法或与其他药物联合用药，用于多个肿瘤类型的治疗，包括：非小细胞肺癌、小细胞肺癌、黑色素瘤、肾细胞癌、肝癌、血液癌症、三阴性乳腺癌、胃癌、胰腺癌。
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Yervoy是一种重组人单克隆抗体，阻断细胞毒性T淋巴细胞相关抗原4（CTLA-4）。CTLA-4是一种T细胞活化的负调控因子，Yervoy与CTLA-4结合后，能阻断CTLA-4与其配体CD80/CD86的相互作用。阻断CTLA-4已被证明能够增强T细胞的活化和增殖。Yervoy在黑色素瘤患者中的疗效作用机制，是间接通过T细胞介导的抗肿瘤免疫反应。FDA于2011年3月批准Yervoy 3mg/kg单药疗法用于不能手术切除或转移性黑色素瘤患者的治疗，目前该药已获全球40多个国家批准。
(Reuters) - Bristol-Myers Squibb Co on Tuesday said it plans this year to begin a late-stage trial testing whether a combination of two of its high-profile immunotherapies can effectively treat lung cancer, easing concerns about the company's intentions.
Company executives spooked investors in January by saying they were not yet planning a late-stage trial that would combine its experimental medicine, nivolumab, and an approved melanoma treatment called Yervoy as a treatment for lung cancer.
The company's cautious timetable suggested to some investors a possible lack of "synergy" between the two drugs when targeting lung cancer. The medicines both enhance the immune system's ability to fight cancer.
But spirits lifted on Tuesday when Brian Daniels, senior vice president of global development for Bristol-Myers, told investors at the Cowen and Co healthcare conference in Boston that the Phase III trial was indeed on track to begin by the end of 2014.
Alex Arfaei, an analyst with BMO Capital Markets, said insights from an ongoing mid-stage trial of the drug combination, presumably durable effectiveness and improved patient survival, had given company officials confidence to move ahead with the costlier larger trial.
Nivolumab is a member of an emerging new class of drugs that block a protein called PD-1, thereby allowing the immune system to recognize cancer cells and go after them. Merck & Co and Roche Holding AG are developing similar drugs and all are believed capable of generating annual sales in the billions of dollars, if approved.
Researchers believe combining the PD-1 inhibitors with other therapies that harness the immune system or target cancer in other ways could be the future of cancer care, in part because the effectiveness of the new drugs does not quickly fall off as is the case with many standard therapies.
"We remain firmly of the view that Bristol-Myers will retain its position as the leader in immuno-oncology (IO) as IO combinations advance in melanoma, kidney, and lung cancer, and as new IO targeted tumors emerge over the next 12-18 months," Leerink Partners analyst Seamus Fernandez said in a research note.
Shares of Bristol-Myers rose 5.5 percent to $56.42 on the New York Stock Exchange on Tuesday.
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