施贵宝公司（NYSE：BMY）今天公布了Opdivo（nivolumab）的I期剂量范围研究CA209-003长期观察结果。评估Opdivo的五年总体生存（OS）数据的第一份报告先前治疗晚期非小细胞肺癌的患者（NSCLC; n = 129）。总体生存率是本研究的探索性终点。之前经过多线治疗的NSCLC患者5年预期达到16％。此次研究的Opdivo的安全性状况已有报道;在此分析中没有发现新的安全问题。这些数据在美国癌症研究协会（AACR）年会上公布（摘要CT077）。
耶鲁癌症中心的CA209-003研究者，医学副教授Scott N.Saveer评论指出：“从历史来看，晚期非小细胞肺癌患者的5年生存率低于5 ％。CA209-003 NSCLC研究结果给我们一个更新的数据，我们观察到Opdivo治疗患者的五年总体生存率估计为16％。而且这些患者在最后一次随访期间大多数没有出现进展。这个研究结果的公布为Opdivo在这类患者群体中的长期生存数据方面提供了重要的依据。“
施贵宝的肺癌研究主管Nick Botwood评论说：“Opdivo是二线NSCLC的标准治疗，已成为这些患者的重要治疗方案。 CA209-003是目前抗PD-1免疫治疗临床试验数据的最长时间的随访分析结果，令人鼓舞的是观察到这些多次治疗的患者中的部分达到了五年以上的长期生存。我们期待进一步评估我们的免疫肿瘤学治疗方案，包括基于Opdivo的组合，目标是改善肺癌患者的长期存活。
Five-Year Survival Observed With Opdivo (nivolumab) in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC), in Phase 1 Study CA209-003
Estimated five-year overall survival rate in previously treated advanced NSCLC patients who received Opdivo was 16%; survival was observed across PD-L1 expression levels and tumor histologies
Data represent the longest survival follow-up with an anti-PD-1 therapy in advanced NSCLC
MONDAY, APRIL 3, 2017 8:30 AM EDT
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced the first report of five-year overall survival (OS) data from the Phase 1 dose-ranging study CA209-003 evaluating Opdivo in patients with previously treated advanced non-small cell lung cancer (NSCLC; n=129). Overall survival was an exploratory endpoint in this study. The estimated OS rate at five years was 16% in heavily pre-treated NSCLC patients; survival was observed across PD-L1 expression levels and tumor histologies. The safety profile of Opdivo from this study was previously reported; no new safety signals were identified in this analysis. These data were featured today during the official press program at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C.
Scott N. Gettinger, M.D., a senior author of CA209-003 and associate professor of medicine, Yale Cancer Center, New Haven, Conn., commented, “Historically, five-year survival rates for patients with advanced NSCLC have been less than 5%. With new data emerging from the NSCLC cohort of CA209-003, we observe that the estimated five-year overall survival rate in Opdivo-treated patients in the study was 16%. In addition, based on investigator assessments, the majority of these patients showed no evidence that their lung cancer had progressed at the time of their last follow-up. These findings offer important new insights into the long-term clinical profile of Opdivo in this patient population.”
These results also will be presented today at AACR from 4:05 – 4:20 p.m. during the Update, Novel Indication, and New Immuno-Oncology Clinical Trials session (Late-Breaking Abstract CT077).
Nick Botwood, M.D., development lead, Lung, Bristol-Myers Squibb, commented, “Opdivo is a standard of care for second-line NSCLC and has been an important treatment option for these patients. CA209-003 represents the longest follow-up analysis of data from a clinical trial testing an anti-PD-1 immunotherapy, and it is encouraging to observe that a subset of these heavily pre-treated patients experienced, at minimum, five years of survival. We look forward to further evaluating our Immuno-Oncology agents, including Opdivo-based combinations, with the goal of improving long-term survival for lung cancer patients.”
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