Daiichi Sankyo and AstraZeneca Launch Three Global Phase III Trials of TROP2 ADC Datopotamab Deruxtecan in Non-Small Cell Lung Cancer

On November 1, Daiichi Sankyo announced that Datopotamab deruxtecan (Dato-DXd), a TROP2 ADC jointly developed with AstraZeneca, hadAdvanced Non-Squamous Non-Small Cell Lung CancerFieldLaunch Three Phase III Clinical Trials。

Screenshot source:Daiichi Sankyo Official WeChat

Dato-DXd is an investigational ADC targeting TROP2, designed using Daiichi Sankyo's proprietary DXd-ADC technology. The drug has been submitted for marketing approval in the United States (NSCLC, HR+/HER2- breast cancer), the European Union (NSCLC, HR+/HER2- breast cancer), Japan (HR+/HER2- breast cancer), and China (HR+/HER2- breast cancer).

Clinical studies have shown that ADC combined with targeted therapy or bispecific immunotherapy may produce stronger and more durable anti-cancer effects in patients with various cancers, including lung cancer.The three clinical studies launched this time aim to explore Dato-DXd in combination with the third-generation EGFR-TKI, osimertinib (Developed by AstraZeneca) and PD-1/TIGIT bispecific antibody Rilvegostomig (Developed by AstraZeneca) The Effect of Combination Therapy, to understand the potential of Dato-DXd in different treatment lines and in treating different types of lung cancer patients.

TROPION-Lung10Is a global, multicenter, open-label, 3-arm Phase III study designed toUntreated PD-L1 high expression (tumor cells [TC]≥50%) and driver gene-negative locally advanced or metastatic nsq-NSCLC patientsIn China, compare the efficacy and safety of Dato-DXd combined with Rilvegostomig treatment or Rilvegostomig monotherapy versus Pembrolizumab.The dual primary endpoints of the study are Progression-Free Survival (PFS) and Overall Survival (OS) assessed by BICR.The trial will enroll approximately 675 patients in Asia, Europe, North America, Oceania, and South America.

TROPION-Lung14Is a global, randomized, multi-center, open-label Phase III study designed toPatients with untreated locally advanced or metastatic EGFRm nsq-NSCLCIn China, the efficacy and safety of Dato-DXd combined with osimertinib versus osimertinib monotherapy are being compared.The primary endpoint of the study was PFS assessed by BICR.The trial will enroll approximately 580 patients in Asia, Europe, North America, Oceania, and South America.

TROPION-Lung15 Is a global, multicenter, open-label, 3-arm Phase III study designed toPatients with locally advanced or metastatic EGFRm nsq-NSCLC who have experienced disease progression after treatment with OsimertinibIn China, compare the efficacy and safety of Dato-DXd with or without osimertinib versus platinum-based doublet chemotherapy.The dual primary endpoints of the study include PFS assessed by BICR in both groups.：Dato-DXd monotherapy versus chemotherapy, Dato-DXd in combination with osimertinib versus chemotherapy. The trial will enroll approximately 630 patients across Asia, Europe, North America, Oceania, and South America.

Daiichi Sankyo and AstraZeneca are developing Dato-DXd globally. As of now,More than 20 studies have evaluated the efficacy and safety of Dato-DXd in various cancers., including NSCLC, triple-negative breast cancer, and HR+/HER2- breast cancer, covering 7 Phase III lung cancer studies and 5 Phase III breast cancer studies.

 Dato-DXd Research Progress
Screenshot source: Insight database