DESTINY-Breast07: Safety (Results from Part 2/Modules 0 [T-DXd monotherapy] and 2 [T-DXd + pertuzumab] as of December 22, 2023 DCO)
Safety Overview1
| n (%) | Module 0 T-DXd monotherapy (n=75) | Module 2 T-DXd + pertuzumab (n=50) |
Medium actual treatment duration, months (range)a T-DXd Pertuzumab | 16.3 (0.7-0.9) N/A | 17.8 (0.9-30.7) 17.6 (0.9-30.7) |
| Any AE, n (%) | 75 (100) | 50 (100) |
| Any AEs Grade >3, n (%) | 39 (52.0) | 31 (62.0) |
| AEs associated with drug interruptions of T-DXd, n (%) | 44 (58.7) | 32 (64.0) |
| AEs associated with dose reduction of T-DXd, n (%) | 12 (16.0) | 8 (16.0) |
| AEs associated with discontinuation of T-DXd, n (%)b | 8 (10.7) | 8 (16.0) |
| Any SAEs, n (%) | 13 (17.3) | 13 (26.0) |
| AEs leading to death, n (%) | 1 (1.3)c | 0 |
AESIs, n (%) Pneumonitis (adjudicated as ILD related to T-DXD) Grade 1 Grade 2 Grade 3 LV dysfunction (possibly related to T-DXd) | 7 (9.3) 2 (2.7) 5 (6.7) 0 5 (6.7) | 7 (14.0) 0 6 (12.0) 1 (2.0) 2 (4.0) |
§Grouped term including neutropenia, decreased neutrophil count, and febrile neutropenia events
Abbreviations
AE = adverse event
;AESI = adverse event of special interest
;AST = aspartate aminotransferase
;DCO = data cut-off
;ILD = interstitial lung disease
;N/A = not applicable
;LV = left ventricular
;SAE = serious adverse event
;T-DXd = trastuzumab deruxtecan
References
1. André F, Hamilton EP, Loi S, et al. DESTINY-Breast07: dose-expansion and analysis of T-DXd monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ mBC. Abstract 1009. Presented at American Society of Clinical Oncology (ASCO) Congress; May 31-June 4, 2024; Chicago, Illinois
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Document ID: 325e86bc-2a1f-401a-b8d6-fa304896a85b
Last updated: 14-February-2023
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