On Tuesday, AstraZeneca Plc ( AZN ) said the survival results did not reach statistical significance in the overall trial population in the TROPION-Lung01 phase 3 trial.

Topline overall survival (OS) results from the TROPION-Lung01 phase 3 trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favored datopotamab deruxtecan (Dato-DXd) compared to docetaxel for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients treated with at least one prior line of therapy. 

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

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo ( DSKYF ) (OTC:DSKYF) (OTC:DSNKY) and being jointly developed by Daiichi Sankyo ( DSKYF ) and AstraZeneca ( AZN ).

The final analysis of OS builds on the PFS results presented at the European Society for Medical Oncology 2023 Congress, which showed that datopotamab deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC. 

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 the only investigational therapy to show a clinically meaningful survival improvement in patients with previously treated nonsquamous non-small cell lung cancer versus docetaxel, which has long been unsurpassed in this post-targeted treatment and post-immunotherapy setting,” said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca ( AZN ).

TROPION-Lung01 enrolled approximately 600 patients.

Price Action: AZN shares were down 2.40% at $76.66 at the last check on Tuesday.

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