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).
第一三共株式會社(以下簡稱Daiichi Sankyo)和阿斯利康(納斯達克市場代碼:AZN)今天宣佈,已經與美國新澤西州凱尼爾沃斯的默克公司(Merck&Co.,Inc.)的一家子公司(在美國和加拿大以外稱為MSD)簽訂了第二份臨牀試驗合作和供應協議,以評估由TROP2指導的DXXan datopotamab deruxtecan(Dato-DXd)的組合
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.
根據Daiichi Sankyo和默克公司(位於美國新澤西州凱尼爾沃斯)之間的協議條款,Daiichi Sankyo將領導TROPION-LUNG08,這是一項全球性的3期試驗,將評估datopotamab deruxtecan聯合KEYTRUDA與KEYTRUDA單獨治療PD-L1高度晚期或轉移性非小細胞肺癌(NSCLC)的幼稚患者的療效。協議的更多細節沒有披露。
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
對於沒有可操作的基因組改變的轉移性非小細胞肺癌患者,目前一線治療的標準是PD-L1免疫療法加或不加以鉑為基礎的化療。1雖然這些療法可以提高這一亞型非小細胞肺癌的存活率,但至少40%到60%的腫瘤對初始治療沒有反應,疾病進展,這突顯了新的創新治療方法的必要性。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."
“進入第二次臨牀試驗合作是基於正在進行的1b期研究的令人鼓舞的結果,並推動datopotamab deruxtecan發展成為治療一線轉移性非小細胞肺癌的3期研究。”第一三共株式會社BPharm,PhD,FOPQ高級副總裁、腫瘤學研發全球負責人吉爾斯·加蘭特(Gilles Gallant)説,“我們將把datopotamab deruxtecan發展成一線轉移性非小細胞肺癌的3期研究。”在這項特定的試驗中,我們將評估將我們的TROP2導向的ADC與抗PD-1療法相結合是否能改善那些以前未經治療、沒有可操作的基因組改變的晚期非小細胞肺癌患者的預後。“
"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."
阿斯利康公司首席醫療官兼腫瘤學首席開發官克里斯蒂安·馬薩塞西(Cristian Massacesi)説:“雖然PD-L1免疫療法可以改善晚期或轉移性非小細胞肺癌的預後,但大多數患者的無進展生存期仍不到一年。TROPION-LUNG08試驗將評估datopotamab deruxtecan和一種針對PD-1途徑的免疫檢查點抑制劑的結合是否會改善這種情況下的結果。“
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階段1b試驗先前的臨牀試驗合作協議於2020年5月簽署,評估datopotamab deruxtecan和KEYTRUDA在使用或不使用鉑類化療的情況下,對既往治療或治療單純的晚期或轉移性非小細胞肺癌(NSCLC)且沒有可操作的基因組改變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.
關於TROPION-LUNG08TROPION-LUNG08是一項全球性、開放標籤、隨機的3期試驗,將評估datopotamab deruxtecan和KEYTRUDA聯合治療PD-L1高度晚期或轉移性非小細胞肺癌(例如,EGFR、ALK、ROS1、NTRK、BRAF、RET、MET或其他已知的可操作突變)的幼稚患者的療效和安全性。TROPION-LUNG08的主要終點是無進展生存期(PFS)和總體生存期(OS)。TROPION-LUNG08預計將在亞洲、歐洲、北美和南美的多個地點招募大約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.)的註冊商標,默克公司是默克公司(Merck&Co.,Inc.)的子公司,位於美國新澤西州凱尼爾沃斯。