Datopotamab deruxtecan shows promise in Phase III trial for NSCLC

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AstraZeneca and Daiichi Sankyo have announced promising results from the TROPION-Lung01 Phase III trial, highlighting datopotamab deruxtecan’s potential as a treatment for advanced nonsquamous non-small cell lung cancer (NSCLC). This trial marks a significant milestone as datopotamab deruxtecan, a TROP2-directed antibody drug conjugate (ADC), showed a clinically meaningful improvement in overall survival (OS) compared to the standard chemotherapy, docetaxel.

High-level OS results from the TROPION-Lung01 trial

The high-level OS results from the TROPION-Lung01 trial, which already met its dual primary endpoint of progression-free survival (PFS), favored datopotamab deruxtecan over docetaxel, particularly in patients with previously treated nonsquamous NSCLC. While the survival results did not reach statistical significance in the overall trial population, the prespecified subgroup of patients with nonsquamous NSCLC experienced a significant improvement in OS.

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Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, commented on the trial’s outcomes: “Datopotamab deruxtecan is the only investigational therapy to show a clinically meaningful survival improvement in patients with previously treated nonsquamous non-small cell lung cancer versus docetaxel. These results reinforce the potential for datopotamab deruxtecan to replace conventional chemotherapy in this late-line setting and underscore our confidence in ongoing trials evaluating this therapy in first-line lung cancer.”

Enhanced Efficacy and Safety Profile

The final analysis of OS builds on the positive PFS results presented at the 2023 European Society for Medical Oncology Congress. The safety profile of datopotamab deruxtecan was consistent with previous analyses, exhibiting fewer dose reductions or discontinuations due to adverse events compared to docetaxel. Notably, no new interstitial lung disease events of any grade were adjudicated as drug-related.

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Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, also shared his insights: “The improvement in overall survival seen with datopotamab deruxtecan, coupled with the previously reported clinically meaningful progression-free survival, suggest that this TROP2-directed antibody drug conjugate could potentially become an important new treatment for patients with nonsquamous non-small cell lung cancer in this advanced setting.”

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Expanding Global Impact

Datopotamab deruxtecan, developed using Daiichi Sankyo’s proprietary DXd ADC Technology, is part of a comprehensive global clinical development program. This program includes more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancer types, including NSCLC, triple-negative breast cancer, and HR-positive, HER2-negative breast cancer.

The data from the TROPION-Lung01 trial will support regulatory applications currently under review globally, including in the US and EU, for the treatment of adult patients with locally advanced or metastatic nonsquamous NSCLC who have received prior systemic therapy.

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