Positive topline results from the TROPION-Breast01 Phase 3 trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progressionfree survival (PFS) compared to investigator’s choice of chemotherapy in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
More than two million people worldwide are diagnosed with breast cancer each year. HR positive, HER2 low or negative breast cancer is the most common subtype, accounting for more than 65% of diagnosed cases. Standard initial treatment for these patients is endocrine therapy but most patients with advanced disease will develop resistance, underscoring the need for additional options. TROP2 is a protein broadly expressed in HR positive, HER2 low or negative breast cancer.
“The positive topline results from TROPION-Breast01 demonstrate the potential for datopotamab deruxtecan to become an important treatment option for patients with HR positive, HER2 low or negative breast cancer in the second-line metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, Inc. “We look forward to realizing the full potential of this TROP2 directed antibody drug conjugate across breast cancer subtypes through our ongoing phase 3 program, including two trials in patients with triple negative breast cancer.”
“Today’s TROPION-Breast01 news is a significant development for patients with HR positive, HER2 low or negative metastatic breast cancer whose tumors have become insensitive to endocrine therapy and who currently face poor outcomes,” said Susan Galbraith, MBBChir, PhD, EVP, Oncology R&D, AstraZeneca. “We are encouraged by these positive results.”
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. Data for the dual primary endpoint of overall survival (OS) were not mature at this interim analysis and the trial will continue as planned to assess OS. The safety profile of datopotamab deruxtecan was consistent with previous hashtag#clinicaltrials in breast cancer with no new safety signals identified. All grade interstitial lung disease rates were low.
