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2024 ESMO IO | 复宏汉霖H药汉斯状®新辅助治疗食管鳞癌研究数据发布

复宏汉霖

2024/12/16

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卡铂上海复宏汉霖生物技术股份有限公司斯鲁利单抗食管鳞状细胞癌 European Medicines Agency

2024年欧洲肿瘤内科学会免疫肿瘤大会（ESMO IO）于当地时间12月11日至13日在瑞士日内瓦及线上同步举行。会上，由复宏汉霖自主研发的创新型单抗H药汉斯状^®（斯鲁利单抗）联合化疗新辅助治疗可切除局晚期食管鳞癌的单臂II期试验数据以壁报形式发布。该研究由浙江大学医学院附属第二医院吴明、沈虹教授团队开展。

H药汉斯状^®（通用名：斯鲁利单抗注射液）为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国和多个东南亚国家获批，惠及患者约9万人。截至目前，H药已在中国获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC）等5项适应症，此外，H药一线治疗ES-SCLC的上市申请也已获得欧盟EMA受理，有望于2025年获批上市。聚焦肺癌和消化道肿瘤等瘤种，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，在全球同步开展10余项肿瘤免疫联合疗法临床试验，于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超4600人。其中，H药联合化疗治疗不可切除局部晚期/复发或转移性食管鳞癌(ESCC)的一线治疗方案已于2023年9月获得中国国家药监局（NMPA）批准上市，为我国食管鳞癌患者带来了免疫治疗新选择。

以下为此次发布的详细信息：

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论文题目：斯鲁利单抗联合化疗新辅助治疗可切除局晚期食管鳞癌的一项单臂II期试验

报告时间：2024年12月12日（日内瓦时间）

研究设计：

关键入组标准：

-病理学和影像学确诊的可手术切除的食管鳞癌初治受试者；

-分期为II-IVA 期（AJCC 第八版食管鳞癌临床分期）；

-治疗前评估可R0手术切除的患者；

-ECOG评分0~1。

治疗方案：

新辅助治疗：斯鲁利单抗4.5mg/kg，i.v，d1+白蛋白紫杉醇260 mg/m2，d1+卡铂AUC=5，i.v，d1，每21天重复一次，治疗三周期。末次给药后4~6周行食管癌根治切除手术。

主要研究终点：

病理完全缓解率(Pathological complete response，pCR率)。

结果：

45例患者最终接受手术，并全部（100%）达到了R0切除，其中3例完全缓解，30例部分缓解，ORR（Objective Response Rate，客观缓解率）达到68.8%，DCR（Disease control rates，疾病控制率）为100%。在病理学上，有14例患者达到原发肿瘤和淋巴结的完全缓解，pCR为31.1%。只有2例患者出现了≥3级AE。

结论：

这项单臂的II期研究证实了斯鲁利单抗联合化疗新辅助治疗局部进展期食管鳞癌显示出值得期待的疗效和可耐受的安全性。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，25项适应症获批，4个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌和非鳞状非小细胞肺癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

Latest Results of Serplulimab in The Neoadjuvant Treatment of ESCC Released In 2024 ESMO IO

From 11 to 13 December 2024, the 2024 European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress took place in Geneva, Switzerland, and online. At this congress, the results of a phase 2 clinical trial of serplulimab in combination with chemotherapy in the neoadjuvant treatment of oesophagexal squamous cell carcinoma have been published in poster presentation. This study was led by Professor Ming Wu and and Professor Hong Shen from the Second Affiliated Hospital Zhejiang University School of Medicine.

HANSIZHUANG (serplulimab), Henlius’ first self-developed innovative Anti-PD-1 mAb, is the world’s first anti-PD-1 mAb for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Up to date, it has been approved in China and several Southeast Asian countries, benefiting about 90,000 patients. In China, it has been approved by the NMPA for the treatment of 5 indications including squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Furthermore，the marketing applications of the first-line treatment for ES-SCLC is under review by the European Medicines Agency (EMA), which is expected to be approved in 2025. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,600 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. From which, HANSIZHUANG in combination with chemotherapy for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC has been approved by the China National Medical Products Administration (NMPA) in September 2023, providing a new treatment option for patients with ESCC.

The detailed results of the study released at 2024 ESMO-IO are as follows:

Title: Serplulimab Combined with Chemotherapy in The Neoadjuvant Treatment of Resectable Oesophagexal Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial

Time: December 12, 2024(CET)

Study Design:

Key Inclusion Criteria:

-Histologically or cytologically diagnosed with ESCC;

-Clinical stage II-IVA, based on the American Joint Committee on Cancer (AJCC) 8th edition;

-Pre-treatment evaluation indicates potential for R0 resection;

-Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

Treatment:

Three cycles of neoadjuvant therapy (21 days per cycle):Serplulimab (4.5mg/kg intravenously on day 1), Carboplatin (AUC=5 intravenously on day 1),Albumin paclitaxel (260 mg/m2 intravenously on day 1).Surgery (4-6 weeks after the last neoadjuvant treatment cycle).

Primary Outcome:

Pathological complete response (PCR).

Results:

Three patients opted out of surgical treatment and withdrew from the study. A total of 45 patients underwent minimally invasive oesophagectomy following serplulimab-based neoadjuvant therapy, and all achieved R0 resection. Complete pCR in both primary tumor and lymph nodes was achieved in 14 patients (31.1%). Only two patients experienced grade 3 AEs.

Conclusion:

In this single-arm phase 2 study, serplulimab in combination with chemotherapy in the neoadjuvant setting for locally advanced ESCC has shown promising antitumor activity and an acceptable safety profile.

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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 25 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (nsNSCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

联系方式

媒体：PR@Henlius.com

投资者：IR@Henlius.com