AstraZeneca reveals mixed interim findings in lung cancer trial

AstraZeneca announced on Monday that datopotamab deruxtecan, or ‘Dato-DXd’, has shown promising results in a trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who had previously received at least one therapy.

The company said the TROPION-Lung01 phase three study's high-level findings revealed that Dato-DXd demonstrated a significant improvement in progression-free survival (PFS) compared to the current standard-of-care chemotherapy, docetaxel.

That outcome represented a positive development for patients, as it suggested that Dato-DXd could offer enhanced efficacy in treating NSCLC.

However, regarding the dual primary endpoint of overall survival (OS), the data was not yet mature at the time of the interim analysis.

Although an early trend was observed in favour of Dato-DXd compared to docetaxel, AstraZeneca said it did not meet the pre-specified threshold for statistical significance.

As a result, the trial would continue as planned to assess overall survival with more comprehensive data.

The pharmaceuticals giant also highlighted that the safety profile of Dato-DXd was consistent with previous clinical trials, with no new safety concerns identified.

Adverse events related to interstitial lung disease, observed across all grades, were generally in line with findings from earlier trials, primarily manifesting as low-grade incidents.

However, a few grade-five events - the most severe - were reportedly observed.

Datopotamab deruxtecan, jointly developed by AstraZeneca and Daiichi Sankyo, is a specially-engineered TROP2-directed DXd antibody drug conjugate (ADC).

“With TROPION-Lung01, we met the dual primary endpoint of progression-free survival, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy,” said Susan Galbraith, AstraZeneca’s executive vice-president of oncology research and development.

“These first phase three trial results from the datopotamab deruxtecan clinical programme provide compelling evidence for the potential role this TROP2-directed antibody drug conjugate can play in treating patients with lung cancer.”

Reporting by Josh White for Sharecast.com.