DESTINY-Breast07: Efficacy (Results from Part 2/Module 7 [T-DXd in patients with active BMs] as of December 22, 2023 DCO)
Best Target Lesion Response per RECIST v1.1 by Investigator1
Overall and best target lesion response per RECIST v1.1 by Investigator
- Confirmed ORR (complete or partial response) was reported in a total of 28 patients (80.0%); complete response was reported in 4 patients (11.4%) and partial response in 24 patients (68.6%)
- Stable disease was reported in 7 patients (20.0%); no patients had disease progression
- Median duration of response was 18.1 months
*Patients had 0% change from baseline
†Disease status at original diagnosis
PFS per RECIST v1.1 by Investigator1
- Median PFS was 19.5 months (80% CI 19.4, 24.3)
- By DCO, there were a total of 15 PFS events (42.9%)
Best IC Lesion Response per RANO-BM by BICR1
Overall and best IC lesion response per RANO-BM by BICR
- Confirmed IC ORR (complete or partial response) was reported in a total of 21 patients (60.0%); complete response was reported in 12 patients (34.3%) and partial response was reported in 9 patients (25.7%)
- Stable disease was reported in 11 patients (31.4%), no patients had disease progression, the response of 1 patient (2.9%) was not evaluable, and there was no evidence of disease in 2 patients (5.7%)
- Median IC duration of response was 14.2 months
Two patients had no evidence of intracranial disease and 11 patients had non-target intracranial lesions only
†Disease status at original diagnosis
IC PFS per RANO-BM1
- Median IC PFS was 15.4 months (80% CI 13.6, NC)
- By DCO, there were a total of 13 IC PFS events (37.1%)
Abbreviations
BICR = blinded independent central review
;BM = brain metastases
;CI = confidence interval
;DCO = data cutoff
;IC = intracranial
;NC = not calculable
;ORR = overall response rate
;PFS = progression free survival
;RANO-BM = Response Assessment Criteria for Neuro-Oncology Brain Metastases
;RECIST v1.1 = Response Evaluation Criteria in Solid Tumors version 1.1
;T-DXd = trastuzumab deruxtecan
References
1. Anders CP, Loi S, Hamilton E, et al. Safety, tolerability, and antitumor activity of T-DXd in patients with HER2-positive mBC and active brain metastases in DESTINY-Breast07. Poster 185P. Presented at European Society for Medical Oncology-Breast Cancer (ESMO-BC) Annual Meeting; May 15-17, 2024; Berlin, Germany.
Please note that this content may contain some data and/or patient populations which are considered off-label in your country. Providing this information does not constitute any recommendation for use. AstraZeneca is providing this material as an information service and professional courtesy.
To help us improve our content for health care professionals, please take this short survey.
Document ID: 325e86bc-2a1f-401a-b8d6-fa304896a85b
Last updated: 14-February-2023
©2023 AstraZeneca. All rights reserved.