AstraZeneca withdraws EU application for experimental lung cancer drug

Feedback from the EU indicated that the trial results, which the application was based on, showed that the drug did not significantly improve overall survival for patients

AstraZeneca has voluntarily withdrawn its marketing authorisation application to the European Medicines Agency (EMA) for datopotamab deruxtecan (Dato-DXd), an experimental precision drug for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). In a press release on Tuesday, the pharma said that the decision follows feedback from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

 

The drug was jointly developed with Japan's Daiichi Sankyo.

 

Challenges in clinical data

EMA’s (CHMP) reviewed the data from the TROPION-Lung01 Phase III trial, which was used to support the application. While datopotamab deruxtecan belongs to a promising class of antibody drug conjugates (ADC), trial results revealed that the drug did not significantly improve overall survival for patients.

 

 

The TROPION-Lung01 data has impacted AstraZeneca’s shares, with investors expressing concerns over its efficacy.

 

AstraZeneca stated, "We remain committed to unlocking the potential of this medicine in lung cancer through our robust clinical development programme, which includes seven pivotal trials in various lung cancer settings."

 

In 2022, nearly 2.5 million lung cancer cases were diagnosed worldwide, highlighting the ongoing global health crisis posed by this deadly disease. Europe alone accounted for nearly half a million of these cases, marking lung cancer as a significant concern in the region.

 

FDA breakthrough therapy designation

Despite the setback in Europe, the United States Food and Drug Administration (FDA) recently granted datopotamab deruxtecan breakthrough therapy designation for the same type of lung cancer when other treatments have failed. This highlights the drug's potential in treating difficult cases.

 

Broader development efforts continue

AstraZeneca and Daiichi Sankyo’s application for datopotamab deruxtecan in the EU for hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, based on the TROPION-Breast01 Phase III trial, remains under review.

 

Datopotamab deruxtecan is a TROP2-directed DXd antibody drug conjugate designed to deliver chemotherapy directly to tumour cells while sparing healthy tissue.