本研究一项多中心、随机、双盲、平行对照的1期临床研究，旨在评估HLX17与KEYTRUDA(美国市售) 在多种已切除实体肿瘤(包括非小细胞肺癌、黑色素瘤或肾细胞癌)受试者中的药代动力学(PK)特徵、有 效性、安全性和免疫原性相似性。合格的受试者将按1:1的比例随机分配至A组和B组，A组受试者每3周 接受一次HLX17治疗;B组受试者前8个周期(24周)每3周接受一次KEYTRUDA治疗，随后转为接受 HLX17治疗，所有受试者持续接受治疗至随机化后12个月(约17个周期)或研究者评估的疾病复发、死 亡、开始新抗肿瘤治疗、出现不可耐受的药物毒性、撤回知情同意书或研究终止(以先发生者为準)。本 研究的主要研究终点为首次给药后从0到21天血清药物浓度-时间曲线下面积(AUC0-21d)以及第6次给药 后稳态下单个给药间隔内的血清药物浓度-时间曲线下面积(AUCss)。次要研究终点包括其他PK参数、 有效性、安全性和免疫原性。 复宏汉霖(02696)公布，近日，公司自主研发的帕博利珠单抗生物类似药HLX17(重组抗PD-1人源化克隆 抗体注射液)(HLX17)在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国 ...

Group 1 - The core finding of the study indicates that the innovative drug Tislelizumab (百泽安) shows significant overall survival benefits for non-small cell lung cancer (NSCLC) patients, with a 4-year overall survival rate exceeding 72.3% for perioperative treatment and a 5-year overall survival rate of 20.1% for second/third-line treatment of advanced NSCLC [1][2] - The study highlights that the overall survival benefit is considered the "gold standard" for evaluating the efficacy of anti-tumor drugs, filling a data gap for Tislelizumab in perioperative treatment of NSCLC [2] - The research demonstrates that the neoadjuvant chemotherapy combined with Tislelizumab significantly reduces the risk of death by 35% for resectable NSCLC patients, with a notable 72.3% of patients surviving beyond 4 years [1][2] Group 2 - The "Healthy China Action - Cancer Prevention and Control Action Implementation Plan (2023-2030)" aims to achieve an overall cancer 5-year survival rate of 46.6% by 2030, emphasizing the critical need for improved lung cancer outcomes, as the current 5-year relative survival rate for all patients is only 28.7% [1] - The transition of PD-1 immune therapy, represented by Tislelizumab, from late-stage treatment to perioperative treatment for operable patients is expected to provide more cure possibilities for a broader lung cancer patient population, enhancing overall survival and quality of life [2]