AstraZeneca Says Second Clinical Trial Collaboration Initiated To Evaluate Datopotamab Deruxtecan In Combination With KETRUDA In Patients With Metastatic Non-Small Cell Lung Cancer
AstraZeneca Says Second Clinical Trial Collaboration Initiated To Evaluate Datopotamab Deruxtecan In Combination With KETRUDA In Patients With Metastatic Non-Small Cell Lung Cancer
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca (NASDAQ:AZN) today announced that a second clinical trial collaboration and supply agreement has been entered with a subsidiary of Merck & Co., Inc., Kenilworth, NJ., USA (known as MSD outside of the United States and Canada) to evaluate the combination of datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC), and Merck & Co., Inc., Kenilworth, NJ., USA's anti-PD-1 therapy KEYTRUDA® (pembrolizumab).
第一三共株式会社(以下简称Daiichi Sankyo)和阿斯利康(纳斯达克市场代码:AZN)今天宣布,已经与美国新泽西州凯尼尔沃斯的默克公司(Merck&Co.,Inc.)的一家子公司(在美国和加拿大以外称为MSD)签订了第二份临床试验合作和供应协议,以评估由TROP2指导的DXXan datopotamab deruxtecan(Dato-DXd)的组合
Under the terms of the agreement between Daiichi Sankyo and Merck & Co., Inc., Kenilworth, NJ., USA, Daiichi Sankyo will lead TROPION-Lung08, a global phase 3 trial that will evaluate datopotamab deruxtecan in combination with KEYTRUDA compared to KEYTRUDA alone in treatment-naïve patients with PD-L1 high advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations, on behalf of the Daiichi Sankyo and AstraZeneca collaboration. Additional details of the agreement were not disclosed.
根据Daiichi Sankyo和默克公司(位于美国新泽西州凯尼尔沃斯)之间的协议条款,Daiichi Sankyo将领导TROPION-LUNG08,这是一项全球性的3期试验,将评估datopotamab deruxtecan联合KEYTRUDA与KEYTRUDA单独治疗PD-L1高度晚期或转移性非小细胞肺癌(NSCLC)的幼稚患者的疗效。协议的更多细节没有披露。
Current standard of care in the first-line treatment of patients with metastatic NSCLC without actionable genomic alterations is PD-L1 immunotherapy with or without platinum-based chemotherapy.1 While these therapies can improve survival in this subtype of NSCLC, at least 40 to 60% of tumors do not respond to initial treatment and disease progression occurs, underscoring the need for new innovative treatment approaches.2,3,4,5
对于没有可操作的基因组改变的转移性非小细胞肺癌患者,目前一线治疗的标准是PD-L1免疫疗法加或不加以铂为基础的化疗。1虽然这些疗法可以提高这一亚型非小细胞肺癌的存活率,但至少40%到60%的肿瘤对初始治疗没有反应,疾病进展,这突显了新的创新治疗方法的必要性。2、3、4、5
"Entering into this second clinical trial collaboration is based on encouraging results in an ongoing phase 1b study and advances development of datopotamab deruxtecan into a phase 3 study in first-line metastatic non-small cell lung cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "In this specific trial, we will evaluate whether combining our TROP2 directed ADC with an anti-PD-1 therapy improves outcomes in patients with previously untreated advanced non-small cell lung cancer with no actionable genomic alterations."
“进入第二次临床试验合作是基于正在进行的1b期研究的令人鼓舞的结果,并推动datopotamab deruxtecan发展成为治疗一线转移性非小细胞肺癌的3期研究。”第一三共株式会社BPharm,PhD,FOPQ高级副总裁、肿瘤学研发全球负责人吉尔斯·加兰特(Gilles Gallant)说,“我们将把datopotamab deruxtecan发展成一线转移性非小细胞肺癌的3期研究。”在这项特定的试验中,我们将评估将我们的TROP2导向的ADC与抗PD-1疗法相结合是否能改善那些以前未经治疗、没有可操作的基因组改变的晚期非小细胞肺癌患者的预后。“
"While PD-L1 immunotherapy can improve outcomes in advanced or metastatic non-small cell lung cancer, the progression-free survival for the majority of patients is still less than one year," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "The TROPION-Lung08 trial will evaluate whether the combination of datopotamab deruxtecan and an immune checkpoint inhibitor that targets the PD-1 pathway will improve outcomes in this setting."
阿斯利康公司首席医疗官兼肿瘤学首席开发官克里斯蒂安·马萨塞西(Cristian Massacesi)说:“虽然PD-L1免疫疗法可以改善晚期或转移性非小细胞肺癌的预后,但大多数患者的无进展生存期仍不到一年。TROPION-LUNG08试验将评估datopotamab deruxtecan和一种针对PD-1途径的免疫检查点抑制剂的结合是否会改善这种情况下的结果。“
A previous clinical trial collaboration agreement was entered in May 2020 for the TROPION-Lung02 phase 1b trial evaluating the safety and efficacy of datopotamab deruxtecan and KEYTRUDA with or without platinum-based chemotherapy in previously treated or treatment-naïve patients with advanced or metastatic NSCLC without actionable genomic alterations.
TROPION-Lung02阶段1b试验先前的临床试验合作协议于2020年5月签署,评估datopotamab deruxtecan和KEYTRUDA在使用或不使用铂类化疗的情况下,对既往治疗或治疗单纯的晚期或转移性非小细胞肺癌(NSCLC)且没有可操作的基因组改变的患者的安全性和有效性。
About TROPION-Lung08
TROPION-Lung08 is a global, open-label, randomized phase 3 trial that will evaluate the efficacy and safety of the combination of datopotamab deruxtecan and KEYTRUDA versus KEYTRUDA alone in treatment-naïve patients with PD-L1 high advanced or metastatic NSCLC without actionable genomic alterations (e.g., EGFR, ALK, ROS1, NTRK, BRAF, RET, MET or other known actionable mutations). The primary endpoints of TROPION-Lung08 are progression-free survival (PFS), as assessed by blinded independent central review (BICR), and overall survival (OS). TROPION-Lung08 is expected to enroll approximately 740 patients at multiple sites in Asia, Europe, North America, and South America.
关于TROPION-LUNG08TROPION-LUNG08是一项全球性、开放标签、随机的3期试验,将评估datopotamab deruxtecan和KEYTRUDA联合治疗PD-L1高度晚期或转移性非小细胞肺癌(例如,EGFR、ALK、ROS1、NTRK、BRAF、RET、MET或其他已知的可操作突变)的幼稚患者的疗效和安全性。TROPION-LUNG08的主要终点是无进展生存期(PFS)和总体生存期(OS)。TROPION-LUNG08预计将在亚洲、欧洲、北美和南美的多个地点招募大约740名患者。
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, U.S.A.
Keytruda®是默克·夏普·多姆公司(Merck Sharp&Dohme Corp.)的注册商标,默克公司是默克公司(Merck&Co.,Inc.)的子公司,位于美国新泽西州凯尼尔沃斯。