TROPION-Lung01 Phase III trial had a local progressive or metastatic non-small cell lung cancer with at least one treatment history in the past ( Datopotamab delxtecan (Dato-DXd) and docetaxel were compared for patients with NSCLC. In this trial, two main endpoints were achieved, progression-free survival (PFS), but the results of the overall survival rate (OS) obtained this time showed that the survival time was longer. Although no statistically significant difference in survival was confirmed in all cases of the trial participants, in a predefined subgroup of non-squamous Upherial NSCLC patients, Datopotamab derxtecan is the current standard chemotherapy. Compared to docetaxel, it showed a clinically significant improvement in overall survival (OS).

The final analysis of the OS further supported the positive results of progression-free survival (PFS) extension announced at the European Society of Clinical Oncology (ESMO) in 2023. In all trial participants, datopotamab delxtecan showed statistically significant improvement in PFS and clinically significant improvement of PFS in patients with non-squamous ethelial non-small cell lung cancer. In the TROPION-Lung01 trial, the entire treatment group was well-balanced and registered based on the patient's tumor tissue, which was consistent with the actual incidence. Specifically, about 75% of patients were NSCLC. ^1,2

The safety profile of Datopotamab Delxtecan in the TROPION-Lung01 trial is consistent with the previous analysis, and there is less ground loss or discontinuation of dosing due to adverse events compared to docetaxel, and new safety concerns The term was not accepted. Also, no cases of drug-related interstitial lung disease were found in any grade.

Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said: " As a result of the TROPION-Lung01 trial, Datopotamab delxtecane clinically significantly improved the survival rate in patients with non-small cell lung cancer (NSCLC) who received secondary treatment compared to the conventional treatment, docetaxel. It became clear that it was the only investigational drug. These results indicate that Datopotamab Delxtecan may replace conventional chemotherapy as an option for late-line lung cancer treatment, and our self- It also supports the faith."

Medical Dr. Kenichi Takeshita, who is the head of global research and development at Daiichi Sankyo, said: " Compared with conventional docetaxel, Datopotamab delxtecan has been reported for improved overall survival, clinically significant extension of progression-free survival, more than double the response rate, and extended response period. From these results, Datopotamab delxtecan, a TROP2 targeted antibody drug complex, suggests that it may be an important new treatment for non-squamous patients with progressive non-small cell lung cancer. This data supports discussions with regulators around the world and aims to deliver Datopotamab Delxtecan to patients as soon as possible. This is a further step towards creating a new standard for cancer treatment."

Datopotamab Derktecan is a TROP2 target DXd antibody drug complex developed by Daiichi Sankyo and jointly developed with AstraZeneca.

The data will be presented at the upcoming Medical Association, and will support regulatory applications that are currently under review around the world. The application targets include treatment for adult patients with locally advanced or metastatic NSCLC (non-squamous cell carcinoma) who have received secondary treatment in the United States and the EU.