Daiichi Sankyo/AstraZeneca Initiates New Phase III Clinical Trial of Dato-DXd in China for Neoadjuvant/Adjuvant Treatment of Previously Untreated TNBC or HR-Low/HER2-Negative Breast Cancer
Daiichi-Sankyo
Pharmaceutical R&D Developer
AstraZeneca
Biopharmaceutical Manufacturer
Recently, according to the CDE Clinical Trial Registration and Information Disclosure Platform, Daiichi-Sankyo/AstraZeneca Dato-DXd has launched a new Phase III clinical trial in China.Neoadjuvant/Adjuvant Treatment for Previously Untreated TNBC or HR Low-Expression/HER2-Negative Breast Cancer Patients(Registration No.: CTR20240839).
Source: CDE Official Website
TheA Study (TROPION-Breast04) was registered and initiated on ClinicalTrials.gov last November (Registration No.:NCT06112379), the enrollment of the world's first subject was completed in the same month.
Dato-DXd is a TROP2 ADC jointly developed by Daiichi Sankyo and AstraZeneca.Breast CancerIs one of the key layout areas of Dato-DXd.
For TNBC, Daiichi Sankyo and AstraZeneca are also conducting 3 global Phase III studies:First-line treatment for TNBCTROPION-Breast02, adjuvant treatment for TNBCTROPION-Breast03, andFirst-line treatment for PD-L1 positive TNBCTROPION-Breast05Research,And have all been launched synchronously in China.
However, the first Phase III breast cancer study conducted by Dato-DXd (TROPION-Breast01) is for HR+/HER2- breast cancer, and the results showed that the primary endpoint of PFS was achieved: as assessed by BICR, compared with investigator-selected chemotherapy, Dato-DXd reduced the risk of disease progression or death by 37%. The median PFS in the Dato-DXd group was 6.9 months, while in the chemotherapy group it was 4.9 months.
Based on this,Daiichi Sankyo has submitted the marketing application for Dato-DXd in China, which was accepted by the NMPA on March 16.
NSCLC This is the first cancer type that Daiichi-Sankyo/AstraZeneca's Dato-DXd aims to conquer.Last month, The two companies jointly announced,Dato-DXd BLA Application Accepted by FDAFor adult patients with locally advanced or metastatic non-squamous NSCLC who have previously received systemic therapy. The PDUFA date is December 20, 2024.Expected to become the world's first TROP ADC for the treatment of lung cancer.
In addition, it is also exploringEfficacy of Dato-DXd in Combination with Immune Checkpoint InhibitorsCurrently, Daiichi Sankyo/AstraZeneca and Merck are collaborating on three clinical trials—TROPION-Lung02, TROPION-Lung07, and TROPION-Lung08—to evaluate the combination therapy of Dato-DXd and Keytruda.
Among them, the jointly conducted Phase Ib clinical trialTROPION-Lung02 StudyIt is the first study to evaluate the combination of TROP2 ADC and immune checkpoint inhibitors for the treatment of patients with advanced NSCLC (with or without platinum-based chemotherapy).The latest results of the TROPION-Lung02 study presented at the 2023 ASCO Annual Meeting show that Dato-DXd in combination with K drug(With or without platinum-based chemotherapy) The ORR in previously untreated patients was 57% and 50%, respectively, with a disease control rate of 91% across cohorts.
As forGastric Cancer, Endometrial CancerOther cancer types also launched a Phase II global clinical trial in July 2022 (Registration Number: NCT05489211), with the first global subject enrolled in September of the same year. The primary endpoint is expected to be completed by March 2025.
