First patient dosed in TROPION-Breast02 phase III trial of Dato-DXd for metastatic triple negative breast cancer.
Daiichi Sankyo announced that the first patient was dosed in the global TROPION-Breast02 phase III trial evaluating the efficacy and safety of Dato-DXd (datopotamab deruxtecan) versus investigator’s choice of chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) not eligible to receive PD-1/PD-L1 inhibitor therapy.
TROPION-Breast02 is a global, randomized, open-label, two-arm, multicenter study assessing the efficacy and safety of datopotamab deruxtecan (6 mg/kg) compared with investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC.
TNBC is defined as HR negative, meaning tumors test negative for estrogen and progesterone hormone receptors, and HER2 negative, determined by an IHC test and/or an ISH test. HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-. Patients must not be candidates for PD-1/PD-L1 inhibitor therapy and must be eligible for one of the investigator’s choice of chemotherapy options.
The dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) assessed by blinded independent central review and overall survival. Secondary endpoints include PFS assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety. TROPION-Breast02 will randomize approximately 600 patients with TNBC at sites in Asia, Africa, Europe and North America.
A comprehensive development program called TROPION is underway globally with trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple solid tumors, including TNBC, HR positive/HER2 negative breast cancer, non-small cell lung cancer, small cell lung cancer, urothelial, gastric and esophageal cancer. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.
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