Phase 3 Trial Results Show Datopotamab Deruxtecan Has Positive Outcomes in Lung Cancer Patients

When compared to docetaxel, the TROPION-Lung01 Phase III trial indicated that datopotamab deruxtecan (Dato-DXd) provided numerically better overall survival (OS) outcomes in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had undergone at least one previous treatment. Although the trial achieved the dual primary endpoint of progression-free survival (PFS) earlier, the survival outcomes for the entire patient population did not demonstrate statistical significance.

Compared to docetaxel, the current standard-of-care treatment, datopotamab deruxtecan demonstrated a clinically relevant improvement in OS in the predefined subset of patients with nonsquamous NSCLC. Previously, at the European Society for Medical Oncology Congress held in 2023, positive PFS results for the drug were presented, and this recent OS analysis builds on that.

The results showed that datopotamab deruxtecan improved PFS in the overall trial population and patients with nonsquamous NSCLC in a clinically meaningful way. About 75% of patients in TROPION-Lung01 had nonsquamous NSCLC, which is comparable with real-world incidence and balanced patient enrollment across treatment arms.

In TROPION-Lung01, the safety profile of datopotamab deruxtecan was consistent with earlier research, showing no new safety concerns and fewer dose reductions or discontinuations due to adverse events compared to docetaxel.

These outcomes reinforce confidence in ongoing trials assessing datopotamab deruxtecan in first-line lung cancer treatment and support the possibility of this treatment replacing conventional chemotherapy in this late-line setting.

These findings will contribute to ongoing discussions with international regulatory bodies about the possibility of delivering datopotamab deruxtecan to patients as soon as feasible. They also represent an advancement in the development of new cancer patient care guidelines.

Developed by Daiichi Sankyo, datopotamab deruxtecan is a DXd antibody and TROP2-directed drug combination currently being developed in collaboration with AstraZeneca.

The findings of this study will be shared at medical conferences in the near future, and data collected through the trial will be used to supplement regulatory applications for the treatment in Europe and the U.S. Currently, the applications for the treatment being reviewed focus on the drug as a treatment for adult patients who have previously received systemic therapy and suffer from locally advanced or metastatic nonsquamous NSCLC.

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