研究進展：免疫治療非小細胞肺癌患者5年生存結果

在經治的非小細胞肺癌（NSCLC）中使用Opdivo（nivolumab）的1期研究（CA209-003）的長期觀察結果顯示：接受Opdivo治療的晚期NSCLC患者的五年總體生存率可達16％，結果並不受PD-L1表達情況和腫瘤組織情況影響。該數據為晚期NSCLC中抗PD-1治療的最長生存率隨訪

施貴寶公司（NYSE：BMY）今天公布了Opdivo（nivolumab）的I期劑量範圍研究CA209-003長期觀察結果。評估Opdivo的五年總體生存（OS）數據的第一份報告先前治療晚期非小細胞肺癌的患者（NSCLC;n =129）。總體生存率是本研究的探索性終點。之前經過多線治療的NSCLC患者5年預期達到16％，結果並不受PD-L1表達情況和腫瘤組織情況影響。此次研究的Opdivo的安全性狀況已有報道;在此分析中沒有發現新的安全問題。這些數據在美國癌症研究協會（AACR）年會上公布（摘要CT077）。

耶魯癌症中心的CA209-003研究者，醫學副教授ScottN.Saveer評論指出：「從歷史來看，晚期非小細胞肺癌患者的5年生存率低於5 ％。CA209-003NSCLC研究結果給我們一個更新的數據，我們觀察到Opdivo治療患者的五年總體生存率估計為16％。而且這些患者在最後一次隨訪期間大多數沒有出現進展。這個研究結果的公布為Opdivo在這類患者群體中的長期生存數據方面提供了重要的依據。「

施貴寶的肺癌研究主管Nick Botwood評論說：「Opdivo是二線NSCLC的標準治療，已成為這些患者的重要治療方案。CA209-003是目前抗PD-1免疫治療臨床試驗數據的最長時間的隨訪分析結果，令人鼓舞的是觀察到這些多次治療的患者中的部分達到了五年以上的長期生存。我們期待進一步評估我們的免疫腫瘤學治療方案，包括基於Opdivo的組合，目標是改善肺癌患者的長期存活。

以下是英文通告，獻給英文八級的讀者：

Five-Year Survival Observed With Opdivo (nivolumab) in PatientsWith Previously Treated Advanced Non-Small Cell Lung Cancer(NSCLC), in Phase 1 Study CA209-003

Estimated five-year overall survival rate in previously treatedadvanced NSCLC patients who received Opdivo was 16%; survival wasobserved across PD-L1 expression levels and tumor histologies

Data represent the longest survival follow-up with an anti-PD-1therapy 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 overallsurvival (OS) data from the Phase 1 dose-ranging study CA209-003evaluating Opdivo in patients with previously treated advancednon-small cell lung cancer (NSCLC; n=129). Overall survival was anexploratory endpoint in this study. The estimated OS rate at fiveyears was 16% in heavily pre-treated NSCLC patients; survival wasobserved across PD-L1 expression levels and tumor histologies. Thesafety profile of Opdivo from this study was previously reported;no new safety signals were identified in this analysis. These datawere featured today during the official press program at theAmerican Association for Cancer Research (AACR) Annual Meeting 2017in Washington, D.C.

Scott N. Gettinger, M.D., a senior author of CA209-003 andassociate professor of medicine, Yale Cancer Center, New Haven,Conn., commented, 「Historically, five-year survival rates forpatients with advanced NSCLC have been less than 5%. With new dataemerging from the NSCLC cohort of CA209-003, we observe that theestimated five-year overall survival rate in Opdivo-treatedpatients in the study was 16%. In addition, based on investigatorassessments, the majority of these patients showed no evidence thattheir lung cancer had progressed at the time of their lastfollow-up. These findings offer important new insights into thelong-term clinical profile of Opdivo in this patientpopulation.」

These results also will be presented today at AACR from 4:05 –4:20 p.m. during the Update, Novel Indication, and NewImmuno-Oncology Clinical Trials session (Late-Breaking AbstractCT077).

Nick Botwood, M.D., development lead, Lung, Bristol-MyersSquibb, commented, 「Opdivo is a standard of care for second-lineNSCLC and has been an important treatment option for thesepatients. CA209-003 represents the longest follow-up analysis ofdata from a clinical trial testing an anti-PD-1 immunotherapy, andit is encouraging to observe that a subset of these heavilypre-treated patients experienced, at minimum, five years ofsurvival. We look forward to further evaluating our Immuno-Oncologyagents, including Opdivo-based combinations, with the goal ofimproving long-term survival for lung cancer patients.」