Latest setback in AstraZeneca's Dato-DXd study: The drug cannot prolong the lives of previously treated breast cancer patients

Monday, AstraZeneca Plc (NASDAQ:AZN) announced high-level results from the Phase 3 TROPION-Breast01 study of datopotamab deruxtecan (Dato-DXd) compared to investigator-choice chemotherapy.

The study did not reach statistical significance in the final analysis of overall survival (OS) in patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer who were previously treated with endocrine therapy and at least one systemic therapy.

The study previously met the dual primary endpoint of progression-free survival.

Read also: Pascal Soriot, CEO of AstraZeneca, provides information on the Chinese compliance investigation and the results of the studies on lung cancer drugs.

In addition, there was an improvement in patient-reported outcomes.

The safety profile of datopotamab deruxtecan was consistent with that observed in the previous analysis and included a lower rate of grade 3 or higher treatment-emergent adverse events compared with chemotherapy. No new safety concerns were identified.

The incidence of interstitial lung disease (ILD) of all severities remained low and no new grade 3 or higher ILD events were observed.

During the study, several antibody drug conjugates (ADCs) were approved, including Enhertu (trastuzumab deruxtecan), it is likely that subsequent treatment after disease progression or discontinuation of treatment in patients may have affected survival outcomes.

Datopotamab deruxtecan is a specifically designed TROP2-targeted DXd ADC developed by Daiichi Sankyo Ltd (OTC:DSKYF) (OTC:DSNKY) and is being jointly developed by AstraZeneca and Daiichi Sankyo.

Earlier this month, AstraZeneca released detailed results from the Phase 3 TROPION-Lung01 study of datopotamab deruxtecan (Dato-DXd) versus docetaxel, the current standard of care chemotherapy for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy.

In the overall study population, OS results were numerically in favor of datopotamab deruxtecan compared with docetaxel (12.9 vs. 11.8 months), but did not reach statistical significance.

On Friday, the FDA approved AstraZeneca’s FluMist as the only self-administered flu vaccine.

FluMist, a needle-free nasal spray, has been approved for self-administration by adults up to 49 years of age or for administration by parents/caregivers to persons aged 2 to 17 years.

Once available, people ages 18 and older will be able to have FluMist delivered directly to their home via FluMist Home.

Price promotion: AZN shares fell 1.86% to $76.92 in premarket trading at last check on Monday.

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This article, “Latest setback in AstraZeneca's Dato-DXd trial: Drug fails to prolong life of previously treated breast cancer patients,” originally appeared on Benzinga.com

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