Datopotamab deruxtecan is intended for use in adults with locally advanced or metastatic nonsquamous NSCLC. Credit: New Africa/Shutterstock.

AstraZeneca and Daiichi Sankyo have withdrawn their marketing authorisation application in the European Union (EU) voluntarily, intended for datopotamab deruxtecan (Dato-DXd), to treat advanced nonsquamous non-small cell lung cancer (NSCLC).

Dato-DXd is intended for use in adults with locally advanced or metastatic nonsquamous NSCLC.

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The withdrawal follows feedback from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The application for Dato-DXd, a TROP2-directed DXd antibody drug conjugate (ADC), was supported by results from the Phase III TROPION-Lung01 clinical trial.

This global, multicentre trial assessed the efficacy and safety of the asset against docetaxel in adults with advanced or metastatic NSCLC.

It included patients with and without actionable genomic alterations, who had already received prior systemic therapy.

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Nearly 600 patients were enrolled for this trial in Europe, Asia, North America, Oceania and South America.

Primary results from the TROPION-Lung01 trial indicated that Dato-DXd significantly improved progression-free survival (PFS) over docetaxel.

Despite the promising data, the companies have chosen to withdraw the application based on regulatory feedback.

A separate application for Dato-DXd, for the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer, remains under review by the EMA and is based on the TROPION-Breast01 Phase III trial.

Datopotamab deruxtecan was discovered by Daiichi Sankyo and is being developed in collaboration with AstraZeneca.

The partnership began in July 2020, following a previous agreement in March 2019 to jointly develop and commercialise another ADC, Enhertu (trastuzumab deruxtecan).

Daiichi Sankyo holds exclusive rights for both ADCs in Japan and is responsible for their manufacturing and supply.