DESTINY-Breast04: Efficacy Results (January 11, 2022 DCO Date)
Progression-Free Survival1,2
PFS in HR+ Patients
PFS in All Patients (HR+ and HR-)
PFS in HR- Patients
Overall Survival1,2
OS in HR+ Patients
OS in All Patients (HR+ and HR-)
OS in HR- Patients
Confirmed Objective Response Rate and Best Overall Response1
| HR+25. | All Patients (HR+ and HR−) | HR-25. | ||||
T-DXd (n=333) | TPC (n=166) | T-DXd (n=373) | TPC (n=184) | T-DXd (n=40) | TPC (n=18) | |
| Confirmed ORR, n (%) [95% CI] | 175 (52.6) [47.0-58.0] | 27 (16.3) [11.0-22.8] |
195 (52.3) [47.1-57.4] |
30 (16.3) [11.3-22.5] |
20 (50.0) [33.8-66.2] |
3 (16.7) [3.6-41.4] |
| CR | 12 (3.6) | 1 (0.6) | 13 (3.5) | 2 (1.1) | 1 (2.5) | 1 (5.6) |
| PR | 164 (49.2) | 26 (15.7) | 183 (49.1) | 28 (15.2) | 19 (47.5) | 2 (11.1) |
| SD | 117 (35.1) | 83 (50.0) | 129 (34.6) | 91 (49.5) | 12 (30.0) | 8 (44.4) |
| PD | 26 (7.8) | 35 (21.1) | 31 (8.3) | 41 (22.3) | 5 (12.5) | 6 (33.3) |
| Not evaluable | 14 (4.2) | 21 (12.7) | 17 (4.6) | 22 (12.0) | 3 (7.5) | 1 (5.6) |
| DCR (CR + PR + SD), n (%) | 293 (88.0) | 110 (66.3) | 325 (87.1) | 121 (65.8) | 32 (80.0) | 11 (61.1) |
Clinical benefit rate25. , n (%) | 237 (71.2) | 57 (34.3) | 262 (70.2) | 62 (33.7) | 25 (62.5) | 5 (27.8) |
| Median DoR, months | 10.7 | 6.8 | 10.7 | 6.8 | 8.6 | 4.9 |
| Median time to response, months | 2.76 | 2.73 | 2.73 | 2.22 | 1.51 | 1.41 |
Best Change in Target Lesions (All Patients)2
Best change in Target Lesions (All Patients)2
Best change in Target Lesions (All Patients)2
Abbreviations
CR = complete response
;DCO = data cut-off
;DCR = disease control rate
;DoR = duration of response
;HR = hormone receptor
;IHC = immunohistochemistry
;ISH = in situ hybridization
;mo = months
;mOS = median overall survival
;mPFS = median progression-free survival
;NE = not evaluable
;ORR = objective response rate
;OS = overall survival
;PD = progressive disease
;PFS = progression-free survival
;PR = partial response
;SD = stable disease
;T-DXd = trastuzumab deruxtecan
;TPC = treatment of physician's choice
References
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