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百时美施贵宝Opdivo必将成为登陆中国的PD-(L)1抗体

https://www.cphi.cn   2018-04-16 11:14 来源:CPhI制药在线 作者:Dopine

目前,百时美施贵宝的Nivolumab,默沙东帕博利珠单抗和君实生物特瑞普利单抗处于中国PD-(L)1抗体上市第一梯队,百时美施贵宝Opdivo很大概率成为首个登陆中国的PD-(L)1抗体。

       4月13日,百时美施贵宝公布Opdivo(Nivolumab)在中国肺癌患者中开展的CheckMate-078(NCT02613507,CTR20150767)最新临床试验数据,相比多西他赛,Opdivo能够使中国经治非小细胞肺癌患者总生存期显著获益(HR 0.68,p=0.0006),结果也会在4月16日于AACR2018年会上口头报告。目前,百时美施贵宝的Nivolumab,默沙东帕博利珠单抗和君实生物特瑞普利单抗处于中国PD-(L)1抗体上市第一梯队,百时美施贵宝Opdivo很大概率成为首个登陆中国的PD-(L)1抗体。

       一.3款PD-(L)1抗体审评进度更新

3款PD-(L)1抗体审评进度更新

       2017年11月1日,百时美施贵宝率先提交nivolumab中国上市申请,正式启动中国上市进程,预计在2018年下半年正式获批。

       目前,根据CDE官方信息,Nivolumab注射液2017年11月1日进入CDE,已完成药理毒理和临床数据审评,药学处于待审评状态。默沙东帕博利珠单抗和君实生物特瑞普利单抗先后进入CDE,处于"排队待审评"状态。

       二.经治NSCLC:CheckMate-078临床试验全部数据公布

       2017年11月30日,百时美施贵宝便公布了独立数据监测委员会关于CheckMate-078的分析结果,临床试验达到总生存期主要终点,提前完成试验。

       CheckMate-078是一项主要在中国人群开展的临床3期、随机、多中心的临床试验,评估Nivolumab对比多西他赛治疗既往接受过治疗的晚期或转移性非小细胞安全性和有效性。对应的临床受理号为JXSL1300032。

Nivolumab

       CheckMate-078表明,相比多西他赛,Opdivo能够使中国经治非小细胞肺癌患者总生存期显著获益(HR 0.68,p=0.0006),并能够降低疾病进展风险,获得具有统计学意义的临床收益,这与CheckMate-017和CheckMate-057总生存期数据保持一致。

       另外,在各个基于组织学分型和PD-L1水平的不同亚组分析中,Opdivo能够延长各个亚组患者的总生存期,具体数据见下表:

Opdivo

       附加资料:

       1. 部分CheckMate系列试验信息汇总:

       CheckMate相关试验总计约80项,下表中列出了几个比较重要的CheckMate临床试验信息:

部分CheckMate系列试验信息汇总

部分CheckMate系列试验信息汇总2

       2. AACR2018-checkmate-078 口头报告信息一览

       ##Session CTMS02 - Updates in Immuno-oncology Trials

       CT114 - Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer (NSCLC): results of the phase 3 CheckMate 078 study

AACR2018-checkmate-078 口头报告信息一览

       Webcast Status

       Webcast Available May 9

       Presenter/Authors

       Y-L. Wu1, S. Lu2, Y. Cheng3, C. Zhou4, J. Wang5, T. Mok6, L. Zhang7, H. Tu1, L. Wu8, J. Feng9, Y. Zhang10, A. V. Luft11, J. Zhou12, Z. Ma13, Y. Lu14, C. Hu15, Y. Shi16, C. Baudelet17, Z. Li17, J. Chang18; 1Guandong Gen. Hosp., Guangzhou, China, 2Shanghai Lung Cancer Ctr., Shanghai Chest Hosp., Shanghai JiaoTong Univ., Shanghai, China, 3Jilin Cancer Hosp., Changchun, China, 4Shanghai Pulmonary Hosp., Shanghai, China, 5Chinese Academy of Med. Sci., Beijing, China, 6Chinese Univ. of Hong Kong, Shatin, Hong Kong, 7Sun Yat-Sen Univ., Guangzhou, China, 8Hunan Cancer Hosp., Changsha, China, 9Jiangsu Cancer Hosp., Beijing, China, 10Zhejiang Cancer Hosp., Hangzhou, China, 11Leningrad Regional Clinical Hosp., Leningrad, Russian Federation, 12First Affiliated Hosp., Coll. of Med., Zhejiang Univ., Hangzhou, China, 13Henan Cancer Hosp., Zhengzhou, China, 14West China Hosp., Chengdu, China, 15Xiangya Hosp., Central South Univ., Changsha, China, 16Natl. Cancer Ctr./Cancer Hosp., Chinese Academy of Med. Sci. and Peking Union Med. Coll., Beijing, China, 17Bristol-Myers Squibb, Princeton, NJ, 18Fudan Univ. Shanghai Cancer Ctr., Shanghai, China

       Disclosures

       Y. Wu: ; AstraZeneca. ; Roche. ; Eli Lilly. ; Pfizer. ; Sanofi. S. Lu: None. Y. Cheng: None. C. Zhou: None. J. Wang: ; Non-financial support; AstraZeneca. T. Mok: ; AstraZeneca, Roche/Genentech, Bristol-Myers Squibb, Boehringer Ingelheim, Novartis, MSD, Pfizer. ; Eli Lilly, Takeda. ; Merck Serono, Vertex, ACEA Biosciences, Oncogenex, Celgene, Ignyta Inc, Fishawack Facilitate Ltd, Janssen, ChiMed. ; Clovis Oncology, SFJ Pharmaceuticals. ; Uncompensated; geneDecode. ; Eisai. ; Taiho. L. Zhang: None. H. Tu:None. L. Wu: None. J. Feng: None. Y. Zhang: None. A.V. Luft: None. J. Zhou: None. Z. Ma: None. Y. Lu: None. C. Hu: None. Y. Shi: None. C. Baudelet: ; Bristol-Myers Squibb. Z. Li: ; Bristol-Myers Squibb. J. Chang: None.

       Abstract

       Introduction: Lung cancer incidence in China has increased and it remains the leading cause of cancer death, highlighting a need for new treatments. We report results from CheckMate 078, the first phase 3 study of an anti-programmed death (ligand) 1 (PD-[L]1) agent in predominantly Chinese patients with NSCLC and disease progression after platinum (Pt)-based chemotherapy.

       Methods: Patients who had disease progression during or after Pt-based doublet chemotherapy were randomized 2:1 to receive nivolumab (3 mg/kg Q2W) or docetaxel (75 mg/m2 Q3W). Patients were included regardless of tumor histology or PD-L1 expression, and randomization was stratified according to both of these factors (≥1% vs <1%/unevaluable tumor PD-L1; squamous vs non-squamous histology). Patients with epidermal growth factor receptor mutation-positive tumors were excluded. The primary endpoint was overall survival (OS); other endpoints included progression-free survival (PFS) and objective response rate (ORR).

       Results: 639 patients were enrolled from December 2015 to December 2016; 504 were randomized. Of all randomized patients, ~90% were from China, 60% had non-squamous tumor histology; tumor PD-L1 expression was <1% in 41% of patients and ≥1% in 50% of patients (9% unevaluable). Minimum follow-up was 8.8 months. OS was significantly improved with nivolumab (n=338) vs docetaxel (n=166); median OS was 12.0 vs 9.6 months, respectively (hazard ratio [HR; 97.7% CI]: 0.68 [0.52, 0.90]; P<0.001). The HR (95% CI) for OS was 0.61 (0.42, 0.89) in patients with squamous NSCLC and 0.76 (0.56, 1.04) in patients with non-squamous NSCLC. In patients with tumor PD-L1 expression <1% and ≥1%, the HR (95% CI) was 0.75 (0.52, 1.09) and 0.62 (0.45, 0.87), respectively. Median PFS was 2.8 months in both treatment arms; PFS curves began to separate at 3 months, resulting in a PFS advantage with nivolumab (HR [95% CI]: 0.77 [0.62, 0.95]; P=0.0147). ORR was 17% with nivolumab vs 4% with docetaxel; median duration of response was not reached with nivolumab (95% CI: 11.1 months, not available [NA]) and 5.3 (95% CI: 3.58, NA) months with docetaxel. Rates of grade ≥3 treatment-related adverse events were lower among patients treated with nivolumab (10%) vs docetaxel (48%).

       Conclusions: In this population of patients with advanced NSCLC previously treated with Pt-based chemotherapy, nivolumab demonstrated superior OS, PFS, and ORR compared with docetaxel. Efficacy and safety of nivolumab in this first randomized controlled trial of nivolumab in NSCLC in a predominantly Chinese patient population were consistent with the results of the pivotal global CheckMate 017/057 studies.

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