近日，复宏汉霖自主开发的创新型产品H药 汉斯状®（斯鲁利单抗，抗PD-1单抗）、抗EGFR单抗HLX07、达雷妥尤单抗生物类似药HLX15的多项最新临床研究数据于2024年欧洲肿瘤学会亚洲分会（ESMO Asia）年会发布。
此次发布数据的研究包括由江苏省肿瘤医院、江苏省肿瘤研究所、南京医科大学附属肿瘤医院沈波教授牵头开展的H药用于治疗鳞状非小细胞肺癌的真实世界研究ASTRUM-004R，上海交通大学医学院附属仁济医院黄吉炜教授发起的呋喹替尼联合斯鲁利单抗用于一线治疗晚期非透明细胞肾细胞癌的II期临床试验，中山大学肿瘤防治中心张力教授牵头开展的HLX07-NPC201，南方医科大学南方医院李常兴教授牵头开展的HLX07-CSCC201，及南京医科大学附属逸夫医院苏钰文教授牵头开展的HLX15-001。其中，呋喹替尼联合斯鲁利单抗用于治疗晚期非透明细胞肾细胞癌的II期研究被选为口头报告；HLX07-NPC201研究数据被接收为LBA（Late-breaking Abstract），由张力教授进行口头报告；HLX07-CSCC201研究结果首次发布于2023 ESMO Asia大会并获评“最佳壁报”奖，此次发布为该研究更新数据。
H药 汉斯状®（斯鲁利单抗）
H药为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，目前已在中国和多个东南亚国家获批上市，也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。以临床需求为导向，公司围绕H药进行了差异化、多维度的适应症布局，覆盖肺癌、消化道肿瘤等高发大癌种。目前，H药已在中国获批5项适应症，惠及患者约9万人。此外，探索H药在多项差异化适应症中疗效的创新联合疗法正在进行中，如H药联合贝伐珠单抗及化疗一线治疗转移性结直肠癌（mCRC），联合化疗用于胃癌的新辅助/辅助治疗，联合化疗同步放疗治疗局限期小细胞肺癌等。
ASTRUM-004R研究
论文题目
ASTRUM-004R研究：斯鲁利单抗一线治疗局部晚期或转移性鳞状非小细胞肺癌的多中心、单臂、真实世界研究
试验设计
ASTRUM-004R是一项由江苏省肿瘤医院和其他14家医院共同参与的真实世界研究，本研究患者的基线特征和化疗选择更贴近临床实际，主要研究终点为客观缓解率（ORR）和真实世界无进展生存期（rwPFS）。
结果
研究纳入2022年11月至2024年6月期间的100例患者进行分析，70 例患者选择紫杉醇（n=34）或白蛋白结合型紫杉醇（n=36）联合铂类和斯鲁利单抗的治疗方案。患者中位年龄68岁，主要为男性（93.0%）和吸烟患者（70%），伴有合并症的患者占37%，此外，42.0%患者接受超过4个周期的诱导治疗，11.0%患者接受放疗。
研究结果显示，ORR为64% (95% CI: 53.8~73.4)，DCR为96% (95% CI: 90.1~98.9)。亚组分析显示，斯鲁利单抗联合白蛋白紫杉醇组与斯鲁利单抗联合紫杉醇组的ORR（75.0% vs 55.9%）和DCR（97.2% vs 100%）结果没有统计学差异。中位PFS和OS尚未达到，1年rwPFS率为51.6%（95%CI: 33.9~78.5），整体安全性可控。
结论
该研究首次证实斯鲁利单抗在晚期肺鳞癌临床实践中良好的疗效和可控的安全性，此外，证明斯鲁利单抗联合紫杉醇或白蛋白紫杉醇的疗效相当，拓展了斯鲁利单抗联合治疗模式，该真实世界的研究数据与ASTRUM-004研究结果保持一致，为斯鲁利单抗联合化疗一线治疗肺鳞癌补充有力证据。
一项针对晚期非透明细胞肾细胞癌的II期研究
论文题目
晚期非透明细胞肾细胞癌（nccRCC）一线治疗中，呋喹替尼联合斯鲁利单抗的疗效和安全性：单臂、多中心临床试验
试验设计
这是一项单臂、多中心、前瞻性II期临床研究，旨在比较斯鲁利单抗联合呋喹替尼一线治疗非透明肾细胞癌（nccRCC）的有效性与安全性的。试验主要分为安全性导入阶段与队列扩展阶段，合计纳入39名患者。安全性导入阶段计划入组6例患者，评估其安全性；队列拓展阶段计划入组33例nccRCC患者，均接受斯鲁利单抗（4.5mg/kg, 静脉输注, 每三周一次）联合呋喹替尼（5mg, 每天一次,口服，2w on/1w off），直至疾病进展，或不可耐受毒性。主要终点是无进展生存期（PFS）；次要终点包括ORR，DCR和安全性。
结果
截止2024年9月30日，纳入16名患者，中位随访时间为8.6个月。中位PFS未达到。6个月PFS率为 77.1%。有8名患者达到PR，ORR为50.0%，DCR为87.5%。没有观察到剂量限制性毒性。
结论
在晚期nccRCC患者中，斯鲁利单抗联合呋喹替尼具有显著的疗效和耐受性。
创新型抗EGFR单抗HLX07
HLX07是复宏汉霖自主研发的针对EGFR靶点的创新型生物药。基于公司成熟的抗体工程改造平台，复宏汉霖在西妥昔单抗的基础上，将HLX07的Fab区人源化，同时使该产品聚糖含量降至最低，以具备更低的免疫原性和良好的靶点亲和力。目前，公司围绕食管鳞癌、皮肤鳞癌、鼻咽癌等多个实体瘤适应症，正在积极开展HLX07单药或联合H药的II期临床探索。
HLX07-NPC201
论文题目
HLX07对比安慰剂联合斯鲁利单抗和化疗一线治疗鼻咽癌：一项随机、双盲、多中心II期研究
试验设计
这是一项随机、双盲、多中心II期研究。此前未接受过系统治疗，且病理组织学确认的不可切除、复发或转移性鼻咽癌患者，或不适合局部或根治性治疗的患者，以2:1比例随机分配接受每3周（Q3W）一次的HLX07（1000 mg）或安慰剂静脉输注。斯鲁利单抗（300 mg）和化疗（吉西他滨和顺铂）亦为Q3W给药，持续时间分别为不超过2年和6个周期。主要终点是独立影像委员会（independent radiology review committee, IRRC）根据RECIST v1.1评估的客观缓解率（objective response rate, ORR）。次要终点包括其他有效性终点、安全性、药代动力学和生物标志物探索。
结果
截至数据截止日期2024年9月6日，75名患者被随机分配接受HLX07（n=50）或安慰剂（n=25）联合斯鲁利单抗和化疗。中位随访时间为10.8个月。相比安慰剂组，HLX07组展现出无进展生存期（progression-free survival, PFS）获益趋势（IRRC评估的中位PFS：未达到[not reached, NR] vs. NR；分层风险比[hazard ratio, HR] 0.74，95% CI 0.33-1.66）。12个月PFS率分别为63.0%和52.8%。IRRC评估的经确认的ORR两组均为72.0%。此外，在中位持续缓解时间方面，HLX07组也展现出获益趋势（中位数：NR vs. NR；分层HR 0.56，95% CI 0.22-1.43）。HLX07组和安慰剂组中分别有14例（28.0%）和8例（32.0%）患者发生治疗相关严重不良事件。
结论
HLX07联合斯鲁利单抗和化疗显示出初步疗效，安全性可控。作为复发或转移性鼻咽癌患者的潜在一线治疗选择，该联合疗法值得进一步研究。
HLX07-CSCC201
论文题目
HLX07单药治疗晚期皮肤鳞状细胞癌的有效性和安全性：一项开放标签、多中心II期研究
试验设计
本研究由两部分组成。第一部分为初步疗效探索，其结果在此报道；第二部分在更大的队列中评估HLX07（在一个基于第一部分结果的固定剂量下）的有效性和安全性。在第一部分中，研究入组有淋巴结或远处转移的晚期皮肤鳞状细胞癌患者，或不适合手术/根治性放疗的局部晚期患者。受试者每3周接受一次1500 mg（A组）或1000 mg（B组）HLX07静脉输注。主要终点是独立影像委员会（independent radiology review committee, IRRC）根据RECIST 1.1评估的客观缓解率（objective response rate, ORR）。次要终点包括其他有效性终点、安全性、药代动力学、免疫原性和生活质量评估。
结果
截至数据截止日期2024年4月30日，中位随访时间分别为19.1个月（A组；n=21）和12.7个月（B组；n=10）。IRRC评估的经确认的ORR在A组为19.0%（95%置信区间[confidence interval, CI] 5.5-41.9），在B组为60.0%（95% CI 26.2-87.8）。IRRC评估的中位无进展生存期在A组为4.9个月（95% CI 1.4-6.5），在B组为7.9个月（95% CI 2.2-11.1）。中位总生存期（overall survival, OS）在A组为11.8个月（95% CI 5.9-不可评估），在B组为未达到。12个月OS率分别为45.7%和56.0%。两组分别有8（38.1%）和3（30.0%）名患者发生了≥3级治疗相关不良事件（treatment-related adverse events, TRAEs）。未报告导致永久停药或死亡的TRAE。
结论
较本研究的上次数据披露，随访时间增加了8.9个月，1000 mg HLX07单药治疗继续在中国晚期皮肤鳞状细胞癌患者中展现出令人鼓舞的抗肿瘤疗效和可控的安全性。
达雷妥尤单抗生物类似药HLX15
HLX15是复宏汉霖自主开发的一款全人源抗CD38 IgG1κ单克隆抗体，有望用于治疗多发性骨髓瘤（Multiple myeloma，MM）。参照中国、欧盟和美国的生物类似药技术指导原则的要求，复宏汉霖采用逐步递进、比对及相似性评价原则，对HLX15与原研达雷妥尤单抗进行了头对头的药学分析和体内外药理学比对研究。2024年6月，HLX15的I期临床研究已成功完成，达到了所有预设的研究终点。
HLX15-001
论文题目
一项在健康男性受试者中比较HLX15和原研达雷妥尤单抗的药代动力学，安全性，耐受性和免疫原性的随机、双盲、I期研究
试验设计
本I期研究由两部分组成。第一部分为单中心、开放标签、随机前导研究。第二部分为评估HLX15与原研达雷妥尤单抗的多中心、随机、双盲的关键研究，其结果在此报道。第二部分招募18-60岁的健康中国男性受试者，按1:1:1:1比例随机分配接受单次8 mg/kg HLX15（A组）或中国（B组）、美国（C组）或欧盟来源的达雷妥尤单抗（D组）静脉输注。主要终点是AUC0-inf。次要终点包括其他药代动力学（pharmacokinetic, PK）参数、安全性和免疫原性。
结果
第二部分入组172例受试者（每组43例），其中165例（A组，n=41；B组，n=41；C组，n=42；D组，n=41）纳入PK分析。任意两组的主要终点AUC0-inf的几何均值比值及其90%置信区间均落在预定义的0.80-1.25等效范围以内，表明HLX15与原研药物具备PK相似性。此外，其他PK参数也呈现可比性。治疗期不良事件、治疗相关的不良事件和特别关注的不良事件多为轻度（1至2级）且在各组间相似。各组的抗药抗体总体阳性率也具有可比性，且未检测到中和抗体。
结论
HLX15与中/美/欧来源的原研达雷妥尤单抗具备相似的PK、安全性和免疫原性特征。作为一款潜在的达雷妥尤单抗生物类似药，HLX15值得进一步研究。
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 5 Clinical Trials Released at ESMO Asia 2024
Recently, results from five clinical trials of Henlius' self-developed products, including novel anti-PD-1 mAb HANSIZHUANG (serplulimab), anti-EGFR mAb HLX07 and daratumumab biosimilar candidate HLX15, were released at European Society for Medical Oncology Asia (ESMO Asia) Congress 2024. The above studies involve ASTRUM-004R led by Professor Bo Shen from Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital, Nanjing Medical University, a phase 2 study exploring fruquintinib combined with serplulimab as 1st line treatment in advanced non-clear cell renal cell carcinoma (nccRCC) initiated and led by Professor Jiwei Huang from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, HLX07-NPC201 led by Professor Li Zhang from Sun Yat-sen University Cancer Center, HLX07-CSCC201 led by Professor Changxing Li from Nanfang Hospital of Southern Medical University, and HLX15-001 led by Professor Yu-wen Su from Sir Run Run Hospital, Nanjing Medical University.
Among them, the study results of Phase 2 Clinical Trial in nccRCC was selected as Mini Oral. And the study results of HLX07-NPC201 were accepted as a Late-breaking Abstract and were presented by Professor Li Zhang. Moreover, the results of HLX07-CSCC201 were first presented at ESMO Asia 2023, where its poster won the best poster award, and were presented with updated results at ESMO Asia 2024.
HANSIZHUANG (Serplulimab)
HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, and the world's first anti-PD-1 mAb approved for the first-line treatment of SCLC. It has been approved in China and multiple countries in Southeastern Asia. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications. Up to date, HANSIZHUANG has been approved by the National Medical Products Administration (NMPA) for the treatment of 5 indications, benefiting around 90,000 patients. Moreover, a wide variety of clinical trials on immuno-oncology combination therapies in differentiated indications has been initiated by the company to further explore the efficacy of the product, such as HANSIZHUANG plus bevacizumab and chemotherapy as first-line treatment for patients with metastatic colorectal cancer (mCRC), HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer (GC), and HANSIZHUANG plus chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC), etc.
ASTRUM-004R
Title
First-Line Serplulimab for Advanced Squamous Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Real-World ASTRUM-004R Study
Study design
ASTRUM-004R is a real-world study conducted by Jiangsu Cancer Hospital and 13 other sites in China. Unlike the strict eligibility criteria of the ASTRUM-004 trial, this study accepts more flexible baseline characteristics and chemotherapy choices. The primary endpoints are objective response rate (ORR) and real-world progression-free survival (rwPFS).
Results
A total of 100 patients were eligible for analysis. Among these, 70 patients elected to receive either paclitaxel (n=34) or nab-paclitaxel (n=36) plus platinum and serplulimab as the immunochemotherapy regimen. The median age was 68.0 years, predominantly males (93.0%) and smokers (70.0%). The majority had an ECOG performance status of 0 or 1 (80.0%), and 37% presented with comorbidities. Additionally, 42.0% of patients received induction therapy for >4 cycles, and 11.0% had undergone radiotherapy. The ORR was 64.0% (95% CI 53.8-73.4), and the DCR was 96.0% (95% CI 90.1-98.9). Although numerically higher ORR was observed in patients treated with nab-paclitaxel (75.0%) compared to paclitaxel (55.9%), this difference was not statistically significant. Moreover, both treatments showed comparable DCRs (100% for paclitaxel vs. 97.2% for nab-paclitaxel). At the time of data cutoff (July 2024), median rwPFS and OS had not been reached, with the 1-year rwPFS rate estimated by the Kaplan-Meier method being 51.6% (95% CI 33.9-78.5). Adverse events of special interest (AESI) were reported in 17.0% of patients.
Conclusion
The results confirmed the efficacy and well-tolerance of serplulimab in squamous NSCLC. In addition, the choice of chemotherapy agents, whether paclitaxel plus platinum, nab-paclitaxel plus platinum, or other combinations, has shown consistent efficacy. These findings support the broader application of serplulimab-based chemotherapy as a first-line treatment.
A Phase 2 Clinical Trial in nccRCC
Title
Efficacy and safety of fruquintinib combined with serplulimab as 1st line treatment in advanced non-clear cell renal cell carcinoma (nccRCC): A single-arm, multicentre clinical trial
Study design
This is a single-arm, multi-center, prospective Phase 2 clinical study, aiming to compare the efficacy and safety of the first-line treatment of non-clear cell renal cell carcinoma (nccRCC) with serplulimab combined with fruquintinib. The trial is mainly divided into safety run-in phase and dose expansion phase, with a total of 39 patients enrolled. In the safety safety run-in phase, 6 patients are planned to be enrolled; in the dose expansion phase, 33 patients are planned to be enrolled. All of enrolled patients will receive serplulimab (4.5 mg/kg, IV, Q3W) combined with fruquintinib (5 mg, QD, PO, 2 weeks on/1 week off) until disease progression or intolerable toxicity. The primary endpoint is PFS; the secondary endpoints include ORR， DCR, and safety.
Results
As of September 30, 2024, 16 patients have been enrolled, with a median follow-up time of 8.6 months. The median PFS has not been reached. The 6-month PFS rate is 77.1%. 8 patients have achieved partial response (PR), with an ORR of 50.0%, and the DCR is 87.5%. No dose-limiting toxicity was observed.
Conclusion
In patients with advanced nccRCC, the combination of serplulimab and fruquintinib has significant efficacy and tolerability.
HLX07
HLX07 is an innovative drug targeting EGFR independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanising its Fab regions and minimizing its glycan contents to generate HLX07 to reduce immunogenicity and maintain a high binding affinity of the product. Currently, Henlius is conducting phase 2 clinical trials to explore HLX07 as monotherapy or in combination with HANSIZHUANG (serplulimab) for the treatment of solid tumours including esophageal squamous cell carcinoma (ESCC), cutaneous squamous cell carcinoma (CSCC), and nasopharyngeal carcinoma (NPC).
HLX07-NPC201
Title
First-line HLX07 vs. Placebo Combined with Serplulimab and Chemotherapy for Nasopharyngeal Cancer: a Randomised, Double-blind, Multicentre Phase 2 study
Study design
This is a randomised, double-blind, multicentre phase 2 study. Patients with pathohistologically confirmed, unresectable, recurrent or metastatic NPC that is not amenable to local or radical treatment and had no prior systemic therapy are randomized 2:1 to receive intravenous HLX07 (1000 mg) or placebo once every 3 weeks (Q3W). Serplulimab (300 mg), and chemotherapy (gemcitabine and cisplatin) were also given Q3W for up to 2 years, and 6 cycles, respectively. The primary endpoint is independent radiological review committee (IRRC)-assessed objective response rate (ORR) per the RECIST version 1.1. Secondary endpoints include other efficacy endpoints, safety, pharmacokinetics and biomarker explorations.
Results
By the data cutoff date of September 06, 2024, 75 patients were randomised to receive HLX07 (n=50) or placebo (n=25), combined with serplulimab and chemotherapy. Median follow-up duration was 10.8 months. A trend of a progression-free survival (PFS) benefit was observed for the HLX07 group compared to the placebo group (IRRC-assessed median PFS: not reached [NR] vs. NR; stratified HR 0.74, 95% CI 0.33-1.66). The 12-month PFS rate was 63.0% and 52.8% for the respective groups. IRRC-assessed confirmed ORR was 72.0% for the two groups. A trend of an improved median duration of response was also observed for the HLX07 group (median: NR vs. NR; stratified HR 0.56, 95% CI 0.22-1.43). Serious treatment-related adverse events occurred in 14 (28.0%) patients in the HLX07 group, and 8 (32.0%) in the placebo group.
Conclusion
The addition of HLX07 to serplulimab and chemotherapy showed preliminary efficacy along with a manageable safety profile. This treatment regimen warrants further investigation as a potential first-line option for R/M-NPC patients.
HLX07-CSCC201
Title
Efficacy and Safety of HLX07 Monotherapy in Advanced Cutaneous Squamous Cell Carcinoma: an Open-label, Multicentre Phase 2 Study
Study design
This study consisted of 2 parts. Part 1 explored the preliminary efficacy and was presented below; part 2 evaluated the efficacy and safety of HLX07 (at a fixed dose based on part 1) in a larger cohort, Patients with advanced CSCC harbouring lymph node or distant metastasis, or locally advanced CSCC that was not amenable to surgery/radical radiation therapy received intravenous HLX07 at 1500 mg (group A) or 1000 mg (group B) once every 3 weeks in part 1. The primary endpoint was independent radiological review committee (IRRC)-assessed ORR per RECIST 1.1. Secondary endpoints included other efficacy measures, safety, pharmacokinetics, immunogenicity, and quality of life assessments.
Results
By the data cutoff date of April 30, 2024, the median follow-up duration was 19.1 months and 12.7 months in group A (n=21), and B (n= 10), respectively. IRRC-assessed confirmed ORR was 19.0% (95% CI 5.5-41.9) in group A and 60.0% (95% CI 26.2-87.8) in group B. IRRC -assessed median progression-free survival was 4.9 months (95% CI 1.4-6.5) in group A and 7.9 months (95% CI 2.2-11.1) in group B. Median OS was 11.8 months (95% CI 5.9-NE) in group A and not reached in group B, with a 12-month OS rate of 45.7% and 56.0% for the respective groups. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 8 (38.1%), and 3 (30.0%) patients in group A and B, respectively. No TRAE leading to treatment discontinuation or death was reported.
Conclusion
With an additional 8.9 months of follow-up, HLX07 monotherapy at 1000 mg continued to demonstrate encouraging antitumour efficacy alone with manageable safety in Chinese patients with advanced CSCC.
HLX15
HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius. The indication to be developed for HLX15 is multiple myeloma (MM). In accordance with the biosimilar guidelines of NMPA, EMA, and FDA, HLX15 has been developed strictly following the principles of stepwise development, comparability and similarity assessment and has been compared head-to-head with reference daratumumab via analytical studies and preclinical studies. In June 2024, the phase 1 clinical trial of HLX15 met its primary endpoint.
HLX15-001
Title
A Randomised, Double-blind, Phase 1 Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of HLX15 and Daratumumab in Healthy Male Participants
Study design
This phase 1 study consisted of 2 parts. Part I was a single-centre, open-label, randomised, pilot study. Part II was a multicentre, randomised, double-blind, pivotal study to compare HLX15 with daratumumab and is presented below. Healthy Chinese male participants aged 18–60 years were enrolled and randomised 1:1:1:1 to receive a single intravenous infusion of HLX15 (group A), China-sourced daratumumab (group B), US-sourced daratumumab (group C), or European Union-sourced daratumumab (group D) at 8 mg/kg. Primary endpoint was the area under the serum concentration-time curve from time 0 to infinity (AUC0-inf). Secondary endpoints included other pharmacokinetic (PK) parameters, safety, and immunogenicity.
Results
Of the 172 participants enrolled in part II (43 per group), 165 (group A, n=41; group B, n=41; group C, n=42; group D, n=41) were included in the PK analysis. The geometric mean ratio and its 90% confidence intervals for primary endpoint AUC0-inf between any two groups were within the predefined equivalence margin of 80.00–125.00%, indicating PK similarity between HLX15 and the reference daratumumab. Other PK parameters were also comparable. Treatment-emergent adverse events (AEs), treatment-related AEs and AEs of special interest were mostly mild (grade 1 to 2) and similar across all groups. The overall positive rate of anti-drug antibody was also comparable across the groups with no neutralizing antibody being detected.
Conclusion
PK similarity between HLX15 and daratumumab from different regions was demonstrated, along with comparable safety and immunogenicity profiles. HLX15 is a promising biosimilar of daratumumab that warrants further investigation.
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
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