Latest Trial Setback For AstraZeneca's Dato-DXd, The Drug Fails To Extend Lives Of Pretreated Breast Cancer Patients

Monday, AstraZeneca Plc AZN released high-level results from the TROPION-Breast01 Phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to the investigator’s choice of chemotherapy.

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

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

Also Read: AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results.

An improvement in patient-reported outcomes was also seen.

The safety profile of datopotamab deruxtecan was consistent with that observed in the previous analysis, including lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy, and no new safety concerns were identified.

All-grade interstitial lung disease (ILD) rates remained low, and no new Grade 3 or higher ILD events were observed.

With multiple antibody-drug conjugates (ADCs) approved during the trial, including Enhertu (trastuzumab deruxtecan), subsequent treatment following patients’ disease progression or treatment discontinuation is likely to have affected survival results.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd ADC discovered by Daiichi Sankyo Ltd DSKYF DSNKY and being jointly developed by AstraZeneca and Daiichi Sankyo.

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

In the overall trial population, OS results numerically favored datopotamab deruxtecan compared to docetaxel (12.9 vs. 11.8 months) but did not reach statistical significance.

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

FluMist, a needle-free nasal spray, was approved for self-administration by adults up to 49 years of age or for parent/caregiver administration to individuals 2-17 years of age.

Once available, individuals 18 and older can have FluMist delivered directly to their homes via FluMist Home.

Price Action: AZN stock is down 1.86% at $76.92 during the premarket session at last check Monday.

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