AZN:Datopotamab Deruxtecan Shows Favorable Survival Results, Falls Short Of Statistical Significance

(RTTNews) - Overall survival results from the TROPION-Lung01 phase 3 trial numerically favored Daiichi Sankyo and AstraZeneca's datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of adult patients with locally advanced or metastatic non-small cell lung cancer or NSCLC treated with at least one prior line of therapy. But survival results did not reach statistical significance in the overall trial population, AstraZeneca said in a statement.

The TROPION-Lung01 phase 3 trial previously met the dual primary endpoint of progression-free survival (PFS).

In the pre-specified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in Overall survival compared to docetaxel, the current standard of care chemotherapy.

The safety profile of datopotamab deruxtecan in TROPION-Lung01 was consistent with the previous analysis, including fewer dose reductions or discontinuations due to adverse events compared to docetaxel and with no new safety concerns identified. No new interstitial lung disease events of any grade were adjudicated as drug-related.

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.

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