Daiichi Sankyo and AstraZeneca Announce Positive Top-Line Results from TROPION-Breast01 Phase III Trial of TROP2 ADC Dato-DXd in HR-Positive, HER2-Low or Negative Metastatic Breast Cancer

Sep 22, 2023 16:49 CST Updated 16:49

Daiichi-Sankyo

Pharmaceutical R&D Developer

AstraZeneca

Biopharmaceutical Manufacturer

On September 22, Daiichi Sankyo and AstraZeneca jointly announced that their TROP2 ADC (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in patients with HR-positive, HER2-low or negative breast cancer in the TROPION-Breast01 Phase III trial.

The results showed that Dato-DXd significantly improved the primary endpoint of progression-free survival (PFS) with statistical and clinical significance in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who had previously received endocrine therapy and at least one systemic treatment.

With ChemotherapyIn comparison,Dato-DXdAnother major endpoint overall survivalOverall Survival (OS) Shows Improvement TrendTrend.In this interim analysis, the OS data are not yet mature, and the trial will continue as planned to assess OS.

Safety was consistent with previous breast cancer clinical trials, with no new safety signals identified.The incidence of interstitial lung disease was low at all grades.

In July, Daiichi Sankyo/AstraZeneca announced that the Phase III trial TROPION-Lung01 of Dato-DXd for the treatment of NSCLC had met its primary endpoint of PFS, while the other primary endpoint, OS, was still under evaluation.

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