![]() ![]() Serious TEAEs were reported in nine patients (20.5%). The most common grade 3 or higher treatment-emergent adverse events (TEAEs) were stomatitis (11%), decreased lymphocyte count (7%), fatigue (7%), vomiting (5%), anemia (2%), decreased neutrophil count (2%) and nausea (2%). The safety profile of datopotamab deruxtecan was consistent with previously reported data with no new safety signals identified. The disease control rate (DCR) was consistent across the overall cohort and previously untreated subgroup at 80% and 81%, respectively. In the subgroup of patients who had not been previously treated with a topoisomerase I inhibitor, median PFS and OS were 7.3 months (95% CI: 3.0-18.0) and 14.3 months (95% CI: 10.5-NE), respectively. In the overall cohort, datopotamab deruxtecan demonstrated median progression-free survival (PFS) of 4.4 months (95% CI: 3.0-7.3) and median overall survival (OS) of 13.5 months (95% CI: 10.1-16.3). “The durable tumor response and disease control seen with datopotamab deruxtecan in patients with pretreated triple negative breast cancer are encouraging, particularly in those patients who had not received previous treatment with topoisomerase I inhibitor-based antibody drug conjugate.” “Triple negative breast cancer is the most aggressive subtype of breast cancer with the average survival rate of less than 18 months for patients with pretreated metastatic disease,” said Aditya Bardia, MD, MPH, Director of Breast Cancer Research Program, Mass General Cancer Center and Associate Professor of Medicine at Harvard Medical School. The median duration of response (DoR) was 16.8 months (95% confidence interval : 5.6-NE) across patient groups. ![]() In a subgroup of 27 patients who had not been previously treated with topoisomerase I inhibitor-based ADCs, the ORR was 44% including one CR, 11 PRs and 10 cases of SD. In the TNBC cohort of TROPION-PanTumor01 (n=44) where patients previously received a median of three lines of treatment for metastatic disease, datopotamab deruxtecan demonstrated an objective response rate (ORR) of 32%, including one complete response (CR), 13 partial responses (PRs) and 18 cases of stable disease (SD) as assessed by blinded independent central review (BICR). 1,2 It is estimated that only 12% of patients with metastatic TNBC survive five years after diagnosis and median overall survival is between 12 to 18 months. Results were presented today as a poster presentation (Abstract #P6-10-03) at the 2022 San Antonio Breast Cancer Symposium (#SABCS22).ĭatopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).Īpproximately 15% of breast cancers are considered triple negative and are associated with higher disease recurrence and worse prognosis compared to other breast cancer subtypes. Tokyo, Munich and Basking Ridge, NJ – (December 9, 2022) – Updated results from the TROPION-PanTumor01 phase 1 trial showed datopotamab deruxtecan (Dato-DXd) continued to demonstrate encouraging responses in patients with heavily pretreated metastatic triple negative breast cancer (TNBC) and disease progression following standard treatment. Datopotamab deruxtecan plus durvalumab demonstrated promising updated results with an objective response rate of 73.6% in first-line treatment of patients with metastatic TNBC in BEGONIA phase 1b/2 trial.Daiichi Sankyo and AstraZeneca’s TROP2 directed ADC showed an encouraging objective response rate of 32% and a manageable safety profile in patients with metastatic TNBC in TROPION-PanTumor01 phase 1 trial.External Sponsored Research (ESR) Investigator Initiated Studies (IIS) and Collaborative Research (CR)ĭatopotamab Deruxtecan Showed Promising Responses as Monotherapy and in Combination with Durvalumab in Patients with Metastatic Triple Negative Breast Cancer in Two Early Trials. ![]() Expanded Access to Investigational Products.Rights & Protections Against Surprise Medical Bills.Daiichi Sankyo Patient Support Programs.Vermont Pharmaceutical Marketer Price Disclosure.CME and Charitable Contributions Disclosure.Daiichi Sankyo Group Global Business Partner Code of Conduct. ![]() Daiichi Sankyo Group Global Anti-Bribery and Anti-Corruption Policy.Standards of Business Conduct & Ethics for Third Parties.Company Governance and Global Structure.Global Business Strategy and Midterm Plan. ![]()
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