The median duration of response (DoR) was 16.8 months across patient groups. In a subgroup of 27 patients who had not been 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), 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 at the 2022 San Antonio Breast Cancer Symposium (SABCS) (abstract #P6-10-03).ĭatopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.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.
Dato dxd trial#
Updated results from the TROPION-PanTumor01 Phase I 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.
Partnerships, alliances and recognition.No documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionableĭriver oncogenes with approved therapies (actionable genomic alterations). Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has Prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV Stage IV metastatic NSCLC disease at the time of randomisation, who have not received
Or IIIC disease not amenable for surgical resection or definitive chemoradiation or Participants with histologically or cytologically documented NSCLC that is Stage IIIB
Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE Version 5.0). Safety of Dato-DXd in combination with durvalumab and carboplatin.PFS2 is defined as the time from randomisation to the earliest of the progression events (following the initial progression), subsequent to first subsequent therapy, or death. Time to Second Progression or Death (PFS2) in the TROP2 biomarker positive and ITT populations.The immunogenicity of Dato-DXd when combined with durvalumab and carboplatin. Anti-Drug Antibody (ADA) for Dato-DXd.Ĭoncentration of Dato-DXd, total anti-TROP2 antibody, and MAAA-1181a in plasma and pharmacokinetic (PK) parameters (such as peak and trough concentrations, as data allow sparse sampling). Pharmacokinetics of Dato-DXd when combined with durvalumab and carboplatin.PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator assessment, or death due to any cause. PFS in the TROP2 biomarker positive and ITT populations.
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