Daiichi Sankyo/AstraZeneca's TROP2 ADC Datopotamab Deruxtecan Receives CDE's Implied Approval for New Combination Therapy in First-Line NSCLC

Intelligent Finance APP learned on December 6 that, according to the CDE official website, Daiichi Sankyo's TROP2 ADC Dato-DXd (DS-1062a) has received tacit approval for another clinical trial application (acceptance number: JXSL2200156). It will be used in combination with pembrolizumab, with or without platinum-based chemotherapy, for the treatment of untreated advanced or metastatic PD-L1 low-expression (tumor proportion score TPS<50%) non-squamous non-small cell lung cancer patients without driver gene alterations. Previously, Dato-DXd (DS-1062a/Dato-DXd) had already initiated three clinical studies targeting non-small cell lung cancer in China.

Dato-DXd is one of the three leading ADC projects that Daiichi Sankyo is prioritizing. It is currently being developed with a primary focus on NSCLC. According to the Insight database, eight clinical trials targeting NSCLC have been initiated, with the highest progress reaching Phase III clinical trials.

Among them, the combination therapy with K drug can be traced back to the previously announced Phase 1b TROPION-Lung02 clinical trial. Based on the data from this study, at the end of October 2021, Daiichi Sankyo (Daiichi Sankyo Company Limited) and Merck (MRK.US) reached another Phase III clinical collaboration, initiating the Phase III Tropion-Lung08 study. In April this year, the Chinese part of this study was launched in China.

In addition, also based on the results of the TROPION-Lung02 study data, according to Daiichi Sankyo's Q2 financial report for the 2022 fiscal year, Daiichi Sankyo/AstraZeneca will initiate the Phase III TROPION-Lung07 study in the second half of the 2022 fiscal year. This study will evaluate the first-line combination therapy with Keytruda for PD-L1 low-expressing non-squamous NSCLC patients, with primary endpoints being PFS and OS.

This study has been registered on ClinicalTrial.gov in September this year (Registration Number: NCT05555732), with an estimated enrollment of 975 participants, and recruitment has not yet begun. In China, the clinical trial application received tacit approval today.

In addition to targeting non-driver gene mutation lung cancer, Daiichi Sankyo previously initiated the Phase III clinical trial TROPION-Lung01 (Registration Number: NCT04656652) for second- and third-line treatment of driver gene mutation NSCLC patients, with corresponding data expected to be released in the second half of this year.

Currently, Dato-DXd is conducting four clinical trials targeting HR-positive, HER2-negative breast cancer as well as triple-negative breast cancer, all of which have progressed to Phase III clinical stages.