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尊龙凯时人生就是搏

科学与治疗领?/p>

君实生物特瑞普利单抗用于广泛期小细胞肺癌一线治疗的新适应症上市申请获受理

2023??9? 下载文章

北京时间2023??9日，君实生物?877.HK?88180.SH）宣布，国家药品监督管理局（NMPA）已受理公司自主研发的抗PD-1单抗药物特瑞普利单抗联合依托泊苷和铂类用于广泛期小细胞肺癌一线治疗的新适应症上市申请。这是特瑞普利单抗在中国递交的第十项上市申请?/p>

肺癌是目前我国发病率和死亡率均排名首位的恶性肿?sup>1。小细胞肺癌（SCLC）是肺癌中侵袭性最强的亚型2，约占所有肺癌病例的15%-20%3，具有进展迅速、早期转移、预后差等特?sup>4。SCLC分为局限期（LS-SCLC）和广泛期（ES-SCLC）。对于LS-SCLC患者，通过标准化疗和放疗，目前已可达到?0%的客观缓解率和约25%?年生存率5,6。然而，大部分患者在就诊时，已被诊断为ES-SCLC，中位生存期不足1?sup>7?年生存率不到10%8，仍是临床未解决的一大难题?/p>

本次新适应症的上市申请主要基于EXTENTORCH研究（NCT04012606），是一项随机、双盲、安慰剂对照、多中心的III期临床研究，由吉林省肿瘤医院程颖教授担任主要研究者，在全?1家临床中心联合开展。该研究旨在比较特瑞普利单抗或安慰剂联合依托泊苷及铂类在一线治疗ES-SCLC的有效性和安全性?/p>

2023?月，EXTENTORCH研究的主要终点达到方案预设的优效边界，特瑞普利单抗由此成为全球首个在ES-SCLC一线治疗III期研究中达成总生存期（OS）和无进展生存期（PFS）双重主要终点的PD-1抑制剂?/p>

结果显示，相比单纯化疗，特瑞普利单抗联合化疗一线治疗ES-SCLC可显著延长患者的PFS和OS。特瑞普利单抗安全性数据与既往研究相似，未发现新的安全性信号。EXTENTORCH研究的详细数据将在近期的国际学术大会上公布?/p>

吉林省肿瘤医院程颖教?/strong>表示：“SCLC早期症状不明显，且肿瘤增殖速度快、恶性程度高，因此大部分患者初诊时已发展为晚期甚至是全身转移，若确诊为ES-SCLC，患者的生存时间?年左右。EXTENTORCH成功证实了在化疗基础上联用特瑞普利单抗一线治疗ES-SCLC可显著改善患者的PFS和OS，可能为ES-SCLC患者提供更丰富、更有效的治疗选择。?strong>

君实生物全球研发总裁邹建军博?/strong>表示：“很高兴在今天见证了特瑞普利单抗?0项适应症的成功申报。自2015年底获准进入临床以来，特瑞普利单抗瞄准中国乃至全球肿瘤患者的未尽之需，已陆续开展了超过40项注册临床试验，并在不同瘤种中表现出稳定、强大的抗肿瘤活性。其中仅肺癌领域，特瑞普利单抗已?项大型III期临床研究取得成功，覆盖了不同亚型和病程阶段。我们将努力推进相关适应症的上市申请工作，让更多肿瘤患者能够受益于我们的创新疗法！?/p>

【参考文献?/h5>
1.    Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 Feb 4.
2.     张爽?小细胞肺癌个体化治疗进展[J].中国肿瘤临床,2017,44(12):571-576.
3.     Gaspar LE, et al. Small-cell lung cancer: prognostic factors and changing treatment over 15 years. Clin Lung Cancer. 2012 Mar;13(2):115-22.
4.     Pesch B, et al. Cigarette smoking and lung cancer–relative risk estimates for the major histological types from a pooled analysis of case-control studies. Int J Cancer. 2012 Sep 1;131(5):1210-9.
5.     Kalemkerian GP. Small Cell Lung Cancer. Semin Respir Crit Care Med. 2016 Oct;37(5):783-796.
6.     Stinchcombe TE, et al. Limited-stage small cell lung cancer: current chemoradiotherapy treatment paradigms. Oncologist. 2010;15(2):187-95.
7.     Lally BE, et al. Small cell lung cancer: have we made any progress over the last 25 years? Oncologist. 2007 Sep;12(9):1096-104.
8.     Socinski MA, et al. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92.

1. 本材料旨在传递前沿信息，无意向您做任何产品的推广，不作为临床用药指导?/em>
2. 若您想了解具体疾病诊疗信息，请遵从医疗卫生专业人士的意见与指导?/em>

关于EXTENTORCH研究

EXTENTORCH是一项随机、双盲、安慰剂对照、多中心的III期研究，旨在比较特瑞普利单抗或安慰剂联合依托泊苷及铂类在一线治疗广泛期小细胞肺癌中的有效性和安全性。由中国临床肿瘤学会（CSCO）副理事长、吉林省肿瘤医院程颖教授担任主要研究者?/p>

该研究在全国启动?1家中心，患者按1:1比例随机分配，接受特瑞普利单抗或安慰剂联合依托泊苷及铂类治疗4-6个周期后，继续特瑞普利单抗或安慰剂维持治疗直到出现疾病进展、不可耐受的毒性或方案规定的其他需要终止治疗的情况?/p>

关于特瑞普利单抗注射液（拓益®?/strong>

特瑞普利单抗注射液（拓益®）作为我国批准上市的首个国产以PD-1为靶点的单抗药物，获得国家科技重大专项项目支持，并荣膺国家专利领域最高奖项“中国专利金奖”?/p>

特瑞普利单抗至今已在全球（包括中国、美国、东南亚及欧洲等地）开展了覆盖超过15个适应症的40多项由公司发起的临床研究。正在进行或已完成的关键注册临床研究在多个瘤种范围内评估特瑞普利单抗的安全性及疗效，包括肺癌、鼻咽癌、食管癌、胃癌、膀胱癌、乳腺癌、肝癌、肾癌及皮肤癌等?/p>

截至目前，特瑞普利单抗已在中国获?项适应症：用于既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗?018?2月）；用于既往接受过二线及以上系统治疗失败的复?转移性鼻咽癌患者的治疗?021?月）；用于含铂化疗失败包括新辅助或辅助化?2个月内进展的局部晚期或转移性尿路上皮癌的治疗（2021?月）；联合顺铂和吉西他滨用于局部复发或转移性鼻咽癌患者的一线治疗（2021?1月）；联合紫杉醇和顺铂用于不可切除局部晚?复发或远处转移性食管鳞癌患者的一线治疗（2022?月）；联合培美曲塞和铂类用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性、不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌的一线治疗（2022?月）?020?2月，特瑞普利单抗首次通过国家医保谈判，目前已?项适应症纳入?022年药品目录》，是国家医保目录中唯一用于治疗黑色素瘤的抗PD-1单抗药物?/p>

在国际化布局方面，特瑞普利单抗已在黏膜黑色素瘤、鼻咽癌、软组织肉瘤、食管癌、小细胞肺癌领域获得美国食品药品监督管理局（FDA）授?项突破性疗法认定?项快速通道认定?项优先审评认定和5项孤儿药资格认定?/p>

目前，特瑞普利单抗联合吉西他?顺铂作为晚期复发或转移性鼻咽癌患者的一线治疗和单药用于复发或转移性鼻咽癌含铂治疗后的二线及以上治疗的生物制品许可申请（BLA）正在接受FDA审评?022?2月和2023?月，欧洲药品管理局（EMA）和英国药品和保健品管理局（MHRA）分别受理了特瑞普利单抗联合顺铂和吉西他滨用于局部复发或转移性鼻咽癌患者的一线治疗以及联合紫杉醇和顺铂用于不可切除局部晚?复发或转移性食管鳞癌患者的一线治疗的上市许可申请（MAA）?strong>