Datopotamab deruxtecan final overall survival results reported in patients with metastatic HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial

This analysis follows the positive PFS results presented at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS. An improvement in patient-reported outcomes was also seen. The PFS data and additional results for key secondary endpoints were published this month in the Journal of Clinical Oncology.

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 identified. All grade interstitial lung disease (ILD) rates remained low with no new Grade 3 or higher ILD events observed.

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

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The metastatic HR-positive breast cancer treatment landscape has advanced remarkably in the last several years to the benefit of patients. Based on the TROPION-Breast01 results, there is evidence of the clinical value of datopotamab deruxtecan in this setting. We will continue discussions with regulatory authorities and apply insights from these results to our clinical development programme for datopotamab deruxtecan in breast cancer.”

Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said: “Datopotamab deruxtecan has previously shown a statistically significant progression-free survival benefit in TROPION-Breast01, a result supported by multiple meaningful secondary measures including patient-reported outcomes. We are proud to have brought forth a new standard of care for patients with metastatic breast cancer with Enhertu and we remain committed to making datopotamab deruxtecan another potential option for patients who can benefit.”

Citation: Publication: Journal of Clinical Oncology. https://doi.org/10.1200/JCO-24-0154; Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non–Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. Authors: Myung-Ju Ahn, MD, PhD , Kentaro Tanaka, MD, PhD , Luis Paz-Ares, MD, PhD, Robin Cornelissen, MD, PhD , Nicolas Girard, MD, PhD , Elvire Pons-Tostivint, MD, PhD ,David Vicente Baz, MD, … for the TROPION-Lung01 Trial Investigators.