TROPION-Breast02 will randomize approximately 600 patients with TNBC at sites in Asia, Africa, Europe and North America. Secondary endpoints include PFS assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety. The dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) assessed by blinded independent central review and overall survival. 5 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. 3,5 HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH. 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. 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. “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.” “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. “The TROPION-Breast02 trial will build on the preliminary efficacy and safety profile seen in the relapsed or refractory triple negative breast cancer arm of the TROPION-PanTumor01 trial to evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients in the first line setting.” “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. 3,4 TNBC is defined by tumors that test negative for estrogen and progesterone hormone receptors (HRs) as well as human epidermal growth factor 2 receptor (HER2), as 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. 1,2,3 Compared to patients with other breast cancer subtypes, the prognosis for patients with metastatic TNBC is generally worse, with five-year survival rates estimated at 12% and median overall survival generally less than two years. Tokyo and Basking Ridge, NJ – (June 13, 2022) – Daiichi Sankyo (TSE: 4568) today announced that the first patient was dosed in the global TROPION-Breast02 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd) 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.ĭatopotamab deruxtecan is a specifically designed TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).Īpproximately 10 to 15% of breast cancers are considered triple negative, the most aggressive subtype of breast cancer. TROPION-Breast02 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Previously Untreated Metastatic Triple Negative Breast Cancer External Sponsored Research (ESR) Investigator Initiated Studies (IIS) and Collaborative Research (CR).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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