"Initial results of datopotamab deruxtecan in patients with pretreated metastatic triple negative breast cancer, a group with a significant unmet need, have been encouraging," said Cristian Massacesi, MD, chief medical officer and Oncology chief development officer, AstraZeneca, in a statement. Requirements also included showing measurable disease per RECIST v1.1, an ECOG performance score of 0 or 1, adequate organ and bone marrow function, and adequate organ and bone marrow function, and minimum life expectancy of 12 months. Women must be at least 1 year post-menopausal before enrolling. Patients must have not received prior chemotherapy, be ineligible for PD-1/PD-L1 therapy, and not be pregnant. To be eligible for inclusion in the study, patients are required to be at least 18 years of age at the time of screening with histologically- or cytologically-documented locally recurrent inoperable or mTNBC. In addition to PFS and OS, the study will evaluate objective response, duration of response, investigator-assessed PFS, time to deterioration, time to first subsequent therapy, PFS2, pharmacokinetics, the immunogenicity of Dato-DXd, and safety as secondary end points. The goal of the study is to assess the safety and efficacy of datopotamab deruxtecan with the coprimary end point of progression-free survival (PFS) and overall survival (OS). TROPION-Breast02 is a phase 3, open-label, randomized study of Dato-DXd versus investigator's choice of chemotherapy in patients who are not candidates for PD-1/PD-L1 inhibitor therapy in first-line locally recurrent inoperable or mTNBC. "Patients with metastatic triple negative breast cancer who are not able to receive PD-1/PD-L1 inhibitor treatment often experience recurrence following chemotherapy, so additional options in the first-line treatment setting are needed," said Gilles Gallant, BPharm, PhD, FOPQ, senior vice president, global head, Oncology Development, Oncology R&D, Daiichi Sankyo, in a press release. There was 1 treatment discontinuation as a result AEs, but no AE-related fatalities. There were dose reductions due to AEs in 18% of patients, and 14% of patients experienced treatment interruption due to AE. The most frequent treatment-emergent adverse events (TEAEs) observed with Dato-DXd in TROPION-PanTumor01 were nausea, stomatitis, vomiting, and fatigue. The median duration of response was not reached (range, 2.7-7.4+ months) in the analysis. A CR/PR was also pending confirmation in the subset at the time of data cutoff. Four percent of patients in the subset were not evaluable for response, and 15% of patients had PD. Confirmed CRs and PRS were observed in 48%, and SD was observed in 33%. 2Ī subset of patients (n = 27) did not receive prior treatment with an antibody drug conjugate, and among these patients, the ORR was 53% with Dato-DXd. There was 1 CR/PR pending confirmation at the time of data cutoff. The disease control rate (DCR) overall was 77%. Notably, 5% were not evaluable for response, and 8 patients had progressive disease (PD). In the mTNBC cohort of 44 patients in TROPION-PanTumor01, the objective response rate by blinded independent central review (BICR) was 34% which included complete responses (CRs) or partial responses (PRs) in 32% of patients, and stable disease (SD) in 39%. TROPION-Breast02 will build on phase 1 data from TROPION-PanTumor01 trial (NCT03401385), in which Dato-DXd demonstrating promising responses in patients with mTNBC. Sponsors: AstraZeneca and Daiichi Sankyo, Inc.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |