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Daiichi Sankyo, AstraZeneca Begin Phase III Trial of Datopotamab Deruxtecan for TNBC

NEW YORK – Daiichi Sankyo said on Monday that it has dosed its first patient in a Phase III clinical trial evaluating its antibody drug conjugate datopotamab deruxtecan for certain patients with triple-negative breast cancer.

The Phase III trial, dubbed TROPION-Breast02, pits datopotamab deruxtecan, or Dato-DXd, against investigator's choice of chemotherapy for roughly 600 previously untreated, locally recurrent, inoperable, or metastatic TNBC patients who are not eligible to receive PD-1/PD-L1 immune checkpoint inhibitors.

The antibody drug conjugate, which Daiichi Sankyo is jointly developing with AstraZeneca, is designed to target the TROP2 antigen on the surface of cancer cells. The TROPION-Breast02 trial comes in the wake of encouraging preliminary data from Dato-DXd-treated TNBC patients in the TROPION-PanTumor01 trial, which the firms presented late last year.

The primary aims of the TROPION-Breast02 trial are to evaluate overall survival as well as progression-free survival, as determined by blinded independent central review, among patients treated with Dato-DXd versus the chemo comparator. Secondary aims include progression-free survival according to investigator assessments as well as objective response rate, duration of response, disease control rate, pharmacokinetics, and safety. The global trial will take place at sites in Asia, Africa, Europe, and North America.

"Initial results of datopotamab deruxtecan in patients with pretreated metastatic triple-negative breast cancer, a group with a significant unmet need, have been encouraging," Cristian Massacesi, AstraZeneca's chief medical officer and oncology chief development officer, said in a statement. "We are building on these early results by moving forward with the TROPION-Breast02 trial, the second pivotal trial of datopotamab deruxtecan in breast cancer, to determine if this antibody drug conjugate may potentially be used earlier in the treatment of metastatic triple-negative breast cancer."