重磅！全球首个登上国际顶级期刊JAMA的小细胞肺癌免疫治疗临床研究，，，，，，，H药 汉斯状?团结化疗一线治疗普遍期小细胞肺癌阳性效果宣布
2022年9月27日，，，，，，，由程颖教授牵头的国际多中心研究——ASTRUM-005研究在全球四大顶级医学期刊之一的《美国医学会杂志》（JAMA，，，，，，，影响因子：157.3）在线揭晓，，，，，，，成为全球首个登上JAMA主刊的小细胞肺癌免疫治疗临床研究。。。。。。。ASTRUM-005研究是复宏汉霖自主研发的抗PD-1单抗H药 汉斯状?（斯鲁利单抗）团结化疗一线治疗普遍期小细胞肺癌（ES-SCLC）的Ⅲ期临床研究，，，，，，，2022年ASCO年会程颖教授首次报告效果后，，，，，，，引起了全球偕行的普遍关注，，，，，，，现在再度登上国际顶级学术舞台，，，，，，，体现了国际学术界的高度认可，，，，，，，彰显出中国研究者的智慧化和生物医药领域国际一流的自主立异实力和临床运营能力。。。。。。。
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程颖教授
通讯作者与第一作者、ASTRUM-005研究主要研究者、吉林省肿瘤医院程颖教授体现：
ASTRUM-005研究中斯鲁利单抗团结化疗获得了现在普遍期小细胞肺癌免疫一线治疗中最长的OS效果，，，，，，，与化疗相比可以延伸4.5个月的生涯，，，，，，，迄今为止最低的HR：0.63，，，，，，，并且近期疗效和远期疗效的效果一致，，，，，，，同时具有优异的清静性。。。。。。。这项研究首次证实了PD-1抑制剂团结化疗同样能够改善普遍期小细胞肺癌的生涯，，，，，，，这也是由我们中国研究者牵头的首个针对ES-SCLC顺应症免疫治疗的国际多中心临床Ⅲ期研究，，，，，，，充分彰显了中国研究者的实力。。。。。。。谢谢所有在该研究中做出孝顺的患者及眷属的配合，，，，，，，也谢谢其他研究者的支付，，，，，，，这项研究为普遍期小细胞肺癌一线免疫治疗睁开了新的一页，，，，，，，为宽大患者带去福音。。。。。。。
OS达15.4个月，，，，，，，刷新一线小细胞肺癌总生涯期纪录
小细胞肺癌（SCLC）约占肺癌总数的15%，，，，，，，是肺癌中侵袭性最强的亚型，，，，，，，分为局限期小细胞肺癌（LS-SCLC）和ES-SCLC。。。。。。。二者配合点是恶性水平高、转移早、疾病希望迅速，，，，，，，总体预后不良。。。。。。。近些年，，，，，，，免疫检查点抑制剂的泛起为ES-SCLC领域的治疗带来新希望，，，，，，，抗PD-L1单抗团结化疗已被海内外权威指南推荐为ES-SCLC一线治疗计划，，，，，，，相较化疗一定水平上改善了患者总生涯期，，，，，，，然而改善水平相对有限，，，，，，，仍需要更有用治疗计划。。。。。。。
ASTRUM-005是一项在既往未接受过治疗的ES-SCLC患者中较量H药团结化疗及慰藉剂团结化疗的临床有用性和清静性的随机、双盲、国际多中心、Ⅲ期临床研究，，，，，，，在中国、土耳其、欧盟波兰、格鲁吉亚等多个国家共开设128个试验中心，，，，，，，其中114个试验中心有受试者加入了筛选，，，，，，，共入组585例受试者，，，，，，，约31.5%为白人。。。。。。。阻止2021年10月22日，，，，，，，本研究共入组的斯鲁利单抗组（n=389）和慰藉剂组（n=196）中位随访时间为12.3个月。。。。。。。斯鲁利单抗组和慰藉剂组的中位OS划分为15.4个月（95% CI 13.3–NE）和10.9个月（95% CI 10.0–14.3），，，，，，，危害比（HR）为0.63（95% CI 0.49–0.82；；；；；； ；p<0.001）。。。。。。。两组的24个月总生涯率划分为43.1%和7.9%。。。。。。。斯鲁利单抗组及慰藉剂组经自力影像评估委员会（IRRC）依据RECIST v1.1评估的中位PFS划分为5.7和4.3个月（HR 0.48，，，，，，，95% CI 0.38–0.59）。。。。。。。清静性方面，，，，，，，斯鲁利单抗组的免疫相关不良事务（irAEs）爆发率与已获批的PD-1/PD-L1单抗相似。。。。。。。
有望惠及全球患者，，，，，，，填补未来五年临床空缺
ASTRUM-005研究的乐成是PD-1抑制剂治疗ES-SCLC的重大突破，，，，，，，基于该项研究，，，，，，，国家药品监视治理局（NMPA）已受理H药一线治疗ES-SCLC顺应症的上市申请；；；；；； ；《CSCO小细胞肺癌诊疗指南（2022版）》也新增斯鲁利单抗团结化疗EC计划作为ES-SCLC一线治疗推荐，，，，，，，为中国ES-SCLC一线治疗提供了更多的选择。。。。。。。不但云云，，，，，，，H药用于治疗SCLC于2022年4月获美国食物药品监视治理局（FDA）孤儿药资格认定。。。。。。。同时，，，，，，，基于FDA针对H药治疗ES-SCLC递交上市申请的正向反响及FDA C类咨询聚会的讨论效果，，，，，，，公司将在美国启动一项桥接临床试验，，，，，，，并拟于2024年Q1前在美国递交响应的上市申请。。。。。。。现在全球尚无一线治疗SCLC的抗PD-1单抗获批，，，，，，，H药有望成为全球首个一线治疗SCLC的抗PD-1单抗，，，，，，，填补未来五年PD-1抑制剂一线治疗小细胞肺癌的临床空缺。。。。。。。
未来，，，，，，，复宏汉霖将一连加码立异，，，，，，，以临床需求为先导，，，，，，，继续高效地为全球患者提供更多可肩负、疗效更好的治疗计划。。。。。。。
关于JAMA
JAMA是偕行评审的国际综合性医学期刊，，，，，，，以增进医学的科学与艺术以及改善公共卫生为主要目的。。。。。。。自1883年一连出书以来，，，，，，，JAMA已成为医学和科学领域最具影响力的期刊之一，，，，，，，现在影响因子为157.3。。。。。。。JAMA也是天下上刊行最普遍的综合性医学类期刊，，，，，，，印刷版订阅数凌驾29万，，，，，，，网络订阅数凌驾160万，，，，，，，期刊网站的年会见量凌驾3800万，，，，，，，具有强盛的社交媒体影响力和国际新闻媒体的曝光率。。。。。。。
关于H药 汉斯状?
H药 汉斯状?为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液），，，，，，，是复宏汉霖首个自主研发的立异型单抗，，，，，，，现在1项顺应症获批上市，，，，，，，3项顺应症上市申请获受理，，，，，，，11项临床试验同步在全球开展。。。。。。。
2022年3月，，，，，，，H药正式获批用于治疗微卫星高度不稳固（MSI-H）实体瘤。。。。。。。围绕H药，，，，，，，复宏汉霖起劲推进其与公司其他产品的协同以及与立异疗法的团结，，，，，，，相继获得中国、美国、欧盟等国家及地区的临床试验允许，，，，，，，在全球同步开展11项肿瘤免疫团结疗法临床试验，，，，，，，普遍笼罩肺癌、食管癌、头颈鳞癌和胃癌等顺应症，，，，，，，周全笼罩肺癌一线治疗。。。。。。。阻止现在，，，，，，，H药已于中国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超3100人，，，，，，，其中2项国际多中心临床试验入组白人的比例凌驾30%，，，，，，，是拥有国际临床数据较多的抗PD-1单抗之一。。。。。。。H药团结化疗一线治疗鳞状非小细胞肺癌（sqNSCLC）、普遍期小细胞肺癌（ES-SCLC）和食管鳞状细胞癌（ESCC）的NDA已获得NMPA受理，，，，，，，H药有望成为全球首个一线治疗SCLC的抗PD-1单抗。。。。。。。别的，，，，，，，该药入选《2022 CSCO小细胞肺癌诊疗指南》作为ES-SCLC治疗推荐，，，，，，，针对ES-SCLC的国际多中心临床研究ASTRUM-005成为全球首个登上JAMA的小细胞肺癌免疫治疗临床研究，，，，，，，其治疗小细胞肺癌（SCLC）也已获得美国FDA孤儿药资格认定。。。。。。。
关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化的立异生物制药公司，，，，，，，致力于为全球患者提供可肩负的高品质生物药，，，，，，，产品笼罩肿瘤、自身免疫疾病、眼科疾病等领域，，，，，，，已在中国上市5款产品，，，，，，，在国际上市1款产品，，，，，，，13项顺应症获批，，，，，，，5个上市注册申请获得中国药监局受理。。。。。。。自2010年建设以来，，，，，，，复宏汉霖已建成一体化生物制药平台，，，，，，，高效及立异的自主焦点能力贯串研发、生产及商业运营全工业链。。。。。。。公司已建设完善高效的全球立异中心，，，，，，，凭证国际药品生产质量治理规范（GMP）标准举行生产和质量管控，，，，，，，一直夯实一体化综合生产平台，，，，，，，其中，，，，，，，上海徐汇基地已获得中国和欧盟GMP认证，，，，，，，松江基地（一）也已获得中国GMP认证。。。。。。。
复宏汉霖前瞻性结构了一个多元化、高质量的产品管线，，，，，，，涵盖20多种立异单克隆抗体，，，，，，，并周全推进基于自有抗PD-1单抗H药汉斯状?的肿瘤免疫团结疗法。。。。。。。继海内首个生物类似药汉利康?（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优?（曲妥珠单抗，，，，，，，欧洲商品名：Zercepac?，，，，，，，澳大利亚商品名：Tuzucip?和Trastucip?）、汉达远?（阿达木单抗）和汉贝泰?（贝伐珠单抗）相继获批上市，，，，，，，立异产品汉斯状?（斯鲁利单抗）已获批用于治疗微卫星高度不稳固（MSI-H）实体瘤，，，，，，，其鳞状非小细胞肺癌、普遍期小细胞肺癌和食管鳞状细胞癌3项顺应症的上市注册申请也正在审评中。。。。。。。公司亦同步就13个产品、11个免疫团结治疗计划在全球规模内开展20多项临床试验，，，，，，，对外授权周全笼罩西欧主流生物药市场和众多新兴市场。。。。。。。
ASTRUM-005: The first immunotherapy clinical study of SCLC published in JAMA, one of the top medical journals in the world?
Shanghai, China, September 27th, 2022 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that ASTRUM-005, an international multi-centre study led by Professor Ying Cheng, has been published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world. ASTRUM-005 trial is a phase 3 study of HANSIZHUANG (serplulimab), an anti-PD-1 monoclonal antibody (mAb) developed by Henlius independently, plus chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). After Prof. Ying Cheng orally presented them at the 2022 ASCO annual meeting, the results of ASTRUM-005 attract wide attention among the global research community. And now, ASTRUM-005 makes its way to the international arena once again, demonstrating the high level of academic acclaim on a global scale, the intelligence of Chinese researchers, and the strength of Chinese pharmaceuticals in terms of independent innovation research and clinical development.
Prof. Ying Cheng, the corresponding author and first author, as well as the leading principal investigator of the study, from Jilin Cancer Hospital, said, “In the ASTRUM-005 trial, serplulimab combined with chemotherapy achieved by far the longest OS in first-line immunotherapy for ES-SCLC. Compared with chemotherapy, the treatment prolonged median OS by 4.5 months and had the lowest HR of 0.63. In addition, the study showed good safety and consistent efficacy over time. ASTRUM-005 is the first study to demonstrate that PD-1 inhibitors plus chemotherapy can improve survival for patients with ES-SCLC. It is also the first international multi-centre phase 3 clinical study led by Chinese researchers to employ immunotherapy for ES-SCLC treatment, showcasing the expertise and excellence of Chinese researchers. I would like to thank all patients and their families, as well as researchers who contributed to this study. It opens a new chapter in first-line ES-SCLC immunotherapy, which will benefit a large number of patients."
OS 15.4 months, a new record
SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases. Both limited stage SCLC (LS-SCLC) and ES-SCLC exhibit high malignancy, strong invasiveness, early metastasis, fast disease progression, and a poor prognosis. The advent of immune checkpoint inhibitors has brought new hope to patients with ES-SCLC. At present, anti-PD-L1 mAbs combined with chemotherapy have been recommended by clinical practice guidelines at home and abroad as the first-line treatment for ES-SCLC. Compared with chemotherapy, the overall survival (OS) of patients with SCLC has been prolonged to a certain extent, but the improvements were still modest, suggesting the need for more effective treatments in this patient population.
ASTRUM-005 is a randomised, double-blind, international, multi-centre, phase 3 clinical study that aims to compare the efficacy and safety of HANSIZHUANG with placebo when combined with chemotherapy in previously untreated patients with ES-SCLC. ASTRUM-005 has set up a total of 128 sites in various countries including China, Turkey, Poland, and Georgia, and enrolled 585 subjects who were screened from 114 sites, among whom 31.5% were White. As of data cutoff for this interim analysis (October 22, 2021), 585 eligible patients were randomised (serplulimab group, n=389; placebo group, n=196), with a median follow-up duration of 12.3 months. Median OS was significantly longer in the serplulimab group (15.4 months, 95% confidence interval [CI] 13.3-not evaluable) than in the placebo group (10.9 months, 95% CI 10.0-14.3) (hazard ratio [HR] 0.63, 95% CI 0.49-0.82; P <0.001). The 24-month OS rate in the two treatment groups were 43.1% and 7.9%, respectively. Median progression-free survival assessed by an independent radiology review committee per RECIST v1.1 was also longer in the serplulimab group compared to the placebo group (5.7 months vs. 4.3 months; HR 0.48, 95% CI 0.38-0.59). Incidence of immune-related adverse events (irAEs) was similar to the approved PD-1/PD-L1 antibodies.
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Providing more treatment options for patients worldwide
The success of ASTRUM-005 is a breakthrough in the treatment of ES-SCLC with PD-1 inhibitors. Based on the results of ASTRUM-005, the New Drug Application (NDA) of HANSIZHUANG in combination with chemotherapy for the first-line treatment of ES-SCLC has been accepted by the National Medical Products Administration (NMPA). Furthermore, HANSIZHUANG has been recommended for the first-line treatment of ES-SCLC by the 2022 CSCO Guidelines for Diagnosis and Treatment of SCLC.
In April 2022, the US Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG for the treatment of SCLC. Based on the positive feedback from FDA Biologics License Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion on the FDA's Type C consultation meeting, Henlius is planning to soon carry out a bridging study in the US and expected to submit BLA to FDA before Q1 of 2024. At present, there is no anti-PD-1 mAb approved for the first-line treatment of SCLC worldwide. HANSIZHUANG is expected to become the world's first anti-PD-1 mAb for the first-line treatment of SCLC and to fill the clinical gap in the next five years.
Looking forward, Henlius will actively improving efficiency through innovations, focusing on unmet medical needs to bring more high-quality and affordable therapies to patients worldwide.
About?JAMA
JAMA, published continuously since 1883, is an international peer-reviewed general medical journal aiming to promote the science and art of medicine and the betterment of the public health. JAMA (impact factor of 157.3, one of the highest in medicine and science) is the most widely circulated general medical journal in the world, with more than 290,000 recipients of the print journal, more than 1.6 million recipients of electronic tables of contents and alerts, and over 38 million annual visits to the journal's website. JAMA's reach includes a growing social media presence and vast international news media exposure.
About HANSIZHUANG
HANSIZHUANG (recombinant humanised anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 1 indication is approved for marketing in China, 3 NDAs have been accepted by the NMPA, and 11 clinical trials are ongoing across the world.
HANSIZHUANG was approved by the NMPA for the treatment of MSI-H solid tumours in March 2022 and its synergy with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 11 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,100 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) for the treatment of ES-SCLC, and the related clinical trial has also become the first study published in JAMA on SCLC immunotherapy. Serplulimab was also granted orphan drug designation by the FDA for treatment of SCLC.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 approved for marketing in overseas markets, 13 indications approved worldwide, and 5 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab; trade name in Europe: Zercepac?; trade names in Australia: Tuzucip? and Trastucip?), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) are under review. What's more, Henlius has conducted over 20 clinical studies for 13 products and 11 combination therapies, expanding its presence in major markets as well as emerging markets.
【参考文献】
Cheng Y, Han L, Wu L, et al. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer:?The ASTRUM-005 Randomized Clinical Trial.?JAMA.2022;328(12):1223–1232. doi:10.1001/jama.2022.16464
*图片素材泉源于JAMA官网
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