Kelun-Biotech's TROP2-ADC SKB264 (Sac-TMT) Second NDA Accepted by NPMA, Locally Advanced or Metastatic EGFR-mutant NSCLC
Kelun-Biotech's TROP2-ADC SKB264 (Sac-TMT) Second NDA Accepted by NPMA, Locally Advanced or Metastatic EGFR-mutant NSCLC
CHENGDU, China, Aug. 20, 2024 /PRNewswire/ -- On August 20, the new drug application (NDA) for the core product sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) based on the positive results from the pivotal OptiTROP-Lung03 study has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK)
中国成都,2024年8月20日 /PRNewswire/ — 8月20日,基于关键Optitrop-Lung03研究的积极结果,核心产品沙曲珠单抗替鲁莫替康(SAC-TMT,前身为SKB264/MK-2870)的新药申请(NDA)已获得国家药品监督管理局(NMPA)药物评估中心(CDE)的批准)中国四川科伦生物制药有限公司(“科伦生物科技”,6990.HK)
OptiTROP-Lung03 is a multi-center, randomized, pivotal clinical study that evaluates sac-TMT monotherapy 5mg/kg every other week (Q2W) as an intravenous injection versus docetaxel for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) who failed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy. At a pre-specified analysis, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) and progression-free survival (PFS) compared with docetaxel.
Optitrop-Lung03 是一项多中心、随机、关键的临床研究,评估每隔一周(Q2W)静脉注射的 SAC-TMT 单一疗法 5mg/kg,与多西他赛治疗局部晚期或转移性表皮生长因子受体 (EGFR) 突变型非小细胞肺癌 (NSCLC) 患者相比,在使用 EGFR-酪氨酸激酶治疗后失败的局部晚期或转移性表皮生长因子受体 (EGFR) 突变非小细胞肺癌 (NSCLC) 患者酶抑制剂(TKI)疗法和铂类化疗。在预先指定的分析中,与多西他赛相比,SAC-TMT单一疗法显示,客观反应率(ORR)和无进展存活率(PFS)具有统计学意义且具有临床意义的改善。
Lung cancer mainly includes non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which NSCLC is the most common pathological type, accounting for about 80%-85% of all lung cancers. The molecular typing of NSCLC patients in China is different from that of Western populations, and EGFR mutation is a common variant gene type, accounting for about 40%-50% of lung adenocarcinoma patients in China [1]. According to the 2024 CSCO guidelines, EGFR-TKIs are the preferred treatment for stage IV EGFR-mutant NSCLC [2]; platinum-containing chemotherapy is the main first-line chemotherapy regimen after resistance to EGFR-TKIs; and existing treatment regimens are ineffective in those who have failed EGFR-TKIs and platinum-containing chemotherapy. Single-agent chemotherapy is the current standard of care for this population, and docetaxel is the most commonly used single-agent chemotherapy, with an ORR of 3.2%-10.8%, a median PFS of only about 2 months, and a median OS of about 6-8 months [3,4,5,6,7]. For patients with locally advanced or metastatic EGFR-mutated NSCLC who have failed treatment with EGFR-TKIs and who have failed platinum-containing chemotherapy, the existing treatment regimens are less efficacious, there is a large unmet clinical need, and new drugs are urgently needed to improve patient survival.
肺癌主要包括非小细胞肺癌(NSCLC)和小细胞肺癌(SCLC),其中非小细胞肺癌是最常见的病理类型,约占所有肺癌的80%-85%。中国非小细胞肺癌患者的分子分型与西方人群不同,表皮生长因子突变是一种常见的变异基因类型,约占中国肺腺癌患者的40%-50% [1]。根据2024年CSCO指南,表皮生长因子-TKI是IV期表皮生长因子突变体非小细胞肺癌的首选治疗方法 [2];含铂化疗是继表皮生长因子-TKI耐药之后的主要一线化疗方案;现有治疗方案对表皮生长因子TKI和含铂化疗失败的患者无效。单药化疗是该人群目前的护理标准,而多西他赛是最常用的单药化疗,其ORR为3.2%-10.8%,中位PFS仅为约2个月,操作系统中位数约为6-8个月 [3,4,5,6,7]。对于局部晚期或转移性表皮生长因子突变的非小细胞肺癌患者,EGFR-TKI治疗失败且含铂化疗失败的患者,现有的治疗方案效果较差,临床需求大量未得到满足,急需新药来提高患者存活率。
Kelun-Biotech has filed the Application for sac-TMT for injection for the treatment of patients with locally advanced or metastatic EGFR-mutant NSCLC who failed after treatment with an EGFR-TKI and platinum-based chemotherapy.
Kelun-Biotech已申请注射SAC-TMT,用于治疗局部晚期或转移性表皮生长因子突变体非小细胞肺癌患者,这些患者在接受表皮生长因子-TKI和铂类化疗治疗后失败。
The Application is the second NDA for sac-TMT that has been accepted by the NMPA. On August 14, 2024, it was announced on the official website of the CDE that the Application was planned to be included in the priority review and approval process of the CDE. Previously, an NDA for sac-TMT in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) was accepted by the NMPA.
该申请是国家药监局接受的第二份SAC-TMT新药申请。2024年8月14日,CDE的官方网站上宣布,计划将该申请纳入CDE的优先审查和批准程序。此前,NMPA批准了针对局部晚期或转移性三阴性乳腺癌(TNBC)患者的SAC-TMT,此前至少接受过两种全身疗法(其中至少一种用于晚期或转移性治疗)的NDA已获得NMPA的认可。
Dr. Junyou Ge, CEO of Kelun-Biotech, said, "It is a great honor to have the second NDA of SKB264 accepted. Kelun-Biotech has always adhered to an innovation-driven development strategy, actively exploring cutting-edge technologies and new approaches to the treatment of major diseases. In response to unmet medical needs, we are committed to the original innovation of new drugs with differentiated advantages and international potential. By enhancing our end-to-end innovative drug development capabilities, we continuously improve the efficiency and success rate of drug research and development, and make every effort to move forward our clinical research progress. We are dedicated to continuously exploring and rapidly validating the clinical value of core projects. The company will always be guided by a caring heart, striving for excellence, and contributing to the great global oncology health cause."
科伦生物科技首席执行官葛俊友博士表示:“SKB264 的第二份保密协议获得接受,我感到非常荣幸。科伦生物科技一直坚持创新驱动的发展战略,积极探索治疗重大疾病的尖端技术和新方法。针对尚未满足的医疗需求,我们致力于具有差异化优势和国际潜力的新药的原创创新。通过增强我们的端到端创新药物开发能力,我们不断提高药物研发的效率和成功率,并尽一切努力推进我们的临床研究进展。我们致力于不断探索和快速验证核心项目的临床价值。公司将始终以一颗充满爱心的心为指导,追求卓越,为伟大的全球肿瘤健康事业做出贡献。”
About Kelun-Biotech
关于科伦生物科技
Kelun-Biotech(6990.HK)is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs.
科伦生物科技(6990.HK)是科伦制药(002422.SZ)的控股子公司,专注于创新生物药物和小分子药物的研发、制造、商业化和全球合作。该公司专注于实体瘤、自身免疫、炎症和代谢性疾病等主要疾病领域,并建立全球化的药物开发和产业化平台,以满足中国和世界其他地区未得到满足的医疗需求。该公司致力于成为创新药物领域的全球领先企业。
At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world's leading proprietary ADC platforms, OptiDC, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit .
目前,公司在实体瘤、自身免疫性、炎症和代谢性疾病等重大疾病领域有30多个正在进行的创新项目,其中包括10多个处于临床阶段的项目和4个处于保密协议阶段的项目,多项全球试验正在包括中国、欧洲和美国在内的多个国家同时进行。该公司已经建立了全球领先的专有ADC平台之一OptiDC,并有5个ADC项目处于临床阶段(其中2个处于保密阶段),多个项目处于临床前阶段。欲了解更多信息,请访问 。
References: |
[1] [Chinese Society of Clinical Oncology (CSCO)(2024)] Guidelines for the diagnosis and treatment of non-small cell lung cancer. |
[2] [Chinese Society of Clinical Oncology (CSCO)(2024)] Guidelines for the diagnosis and treatment of non-small cell lung cancer. |
[3] Hanna N,Shepherd FA, Fossella Fv, et al.(2004) |
[4] Randomized Phase lll Trial of Pemetrexed, versus Docetaxel in Patients with Non-Small-Cell Lung CancerPreviously Treated with Chemotherapy.Journa otClcaOncology,22:1589-1597. |
[5] Jyoti D. Patel, Mleng J, et al. (2023) Clinical charateristics, real-world treatment patterns, and clinicaloutcomes among patients with previously treated metastatic or unresectable EGFR-mutated non-small cellung cancer in the United States. Cancer Research.83:6754. |
[6] KawaguchiT, Ando M. Asami K, et a. 2014) Randomized phase ll trlal of erlotnib versus docetaxe assecond- or third-line therapy in patients with advanced non-small-cell lung cancer. Docetaxel and Erlotinibung Cancerlra (DEhA)Journa of cinica32(18):1902-1908. |
[7] Krzakowski M, Ramlau R, Jassem J, et al. (2010)] Phase III trial comparing vinflunine with docetaxel in second-line advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy. Journal of Clinical Oncology, 28(1. |
参考文献: |
[1] [中国临床肿瘤学会(CSCO)(2024)] 非小细胞肺癌的诊断和治疗指南。 |
[2] [中国临床肿瘤学会(CSCO)(2024)] 非小细胞肺癌的诊断和治疗指南。 |
[3] Hanna N、Shepherd FA、Fossella Fv 等 (2004) |
[4] 培美曲塞对比多西他赛的随机阶段lll试验,用于先前接受过化疗的非小细胞肺癌患者。Journa otclcaOncology,22:1589-1597。 |
[5] Jyoti D. Patel、Mleng J 等人(2023)美国先前接受过治疗的转移性或不可切除的表皮生长因子突变非小细胞癌患者的临床特征、现实世界的治疗模式和临床结果。癌症研究。83:6754。 |
[6] Kawaguchit、Ando m. Asami k 等人。2014)在晚期非小细胞肺癌患者中,erlotnib 与 docetaxe 作为二线或三线疗法的随机阶段 ll trlal 对比。Docetaxel 和 Erlotinibung Cancerlra(DeHA)Cinica32 (18): 1902-1908。 |
[7] Krzakowski m、Ramlau R、Jassem J 等人(2010)] 三期试验,比较了先前接受含铂化疗治疗的二线晚期非小细胞肺癌的长春氟宁和多西他赛。临床肿瘤学杂志,28(1. |
SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
来源:四川科伦生物制药有限公司