DESTINY-Breast03: Asia Subgroup Safety Results (May 21, 2021 DCO Date)
Overall Drug-Related Safety Summary1
Median treatment duration was 13.3 months (range, 0.7-29.8) for T-DXd and 5.5 months (range, 0.7-25.1) for T-DM11
| n (%) | T-DXd (n=147) | T-DM1 (n=159) |
| Any drug-related TEAE | 144 (98.0) | 140 (88.1) |
| Drug-related TEAE grade ≥3 | 69 (46.9) | 74 (46.5) |
| Serious drug-related TEAE | 15 (10.2) | 11 (6.9) |
| Drug-related TEAE associated with discontinuation | 20 (13.6) | 10 (6.3) |
| Drug-related TEAE associated with dose reduction | 35 (23.8) | 26 (16.4) |
| Drug-related TEAE associated with an outcome of death | 0 (0.0) | 0 (0.0) |
Drug-Related TEAEs in ≥30% of Patients in T-DXd Arm1
- The incidence of drug-related TEAEs in Asia was generally consistent with those overall1
- Most drug-related TEAEs were gastrointestinal or hematologic in nature1
- The most common T-DXd-related TEAEs were nausea, neutropenia, vomiting, and fatigue1
System Organ Class Preferred term, n (%) | T-DXd (n=147) | T-DM1 (n=159) | ||
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| Drug-related blood and lymphatic system disorders | ||||
| 70 (47.6) | 36 (24.5) | 23 (14.5) | 8 (5.0) |
| 47 (32.0) | 12 (8.2) | 22 (13.8) | 6 (3.8) |
| 56 (38.1) | 14 (9.5) | 14 (8.8) | 1 (0.6) |
| 49 (33.3) | 17 (11.6) | 103 (64.8) | 55 (34.6) |
| Drug-related gastrointestinal disorders | ||||
| 96 (65.3) | 6 (4.1) | 34 (21.4) | 1 (0.6) |
| 63 (42.9) | 2 (1.4) | 7 (4.4) | 1 (0.6) |
| Drug-related general disorders | ||||
| 63 (42.9) | 8 (5.4) | 38 (23.9) | 1 (0.6) |
| Drug-related skin and subcutaneous tissue disorders | ||||
| 56 (38.1) | 0 | 4 (2.5) | 0 |
Adverse events were managed according to the protocol
aThis category includes the preferred terms neutrophil count decreased and neutropenia; bThis category includes the preferred terms hemoglobin decreased, red blood cell count decreased, anemia, and hematocrit decreased; cThis category includes the preferred terms white blood cell count decreased and leukopenia; dThis category includes the preferred terms platelet count decreased and thrombocytopenia; eThis category includes the preferred terms fatigue, asthenia, and malaise.
ILD/Pneumonitis in Different Regions1-3
- There was no grade 4 or 5 adjudicated drug-related ILD with T-DXd
- ILD rates were similar between the overall population and the Asia subgroup, and between the Asia and non-Asia subgroup2
- Rates of drug-related ILD trended higher in patients from Japan, but no grade ≥3 events were observed in this population1
| n (%) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Any Grade | |
| Overall | T-DXd (n = 257) | 7 (2.7) | 18 (7.0) | 2 (0.8) | 0 | 0 | 27 (10.5) |
| T-DM1 (n = 261) | 4 (1.5) | 1 (0.4) | 0 | 0 | 0 | 5 (1.9) | |
| Asia subgroupa | T-DXd (n = 147) | 5 (3.4) | 10 (6.8) | 1 (0.7) | 0 | 0 | 16 (10.9) |
| T-DM1 (n = 159) | 3 (1.9) | 1 (0.6) | 0 | 0 | 0 | 4 (2.5) | |
| Japan subgroup | T-DXd (n = 36) | 4 (11.1) | 4 (11.1) | 0 | 0 | 0 | 8 (22.2) |
| T-DM1 (n = 31) | 2 (6.5) | 1 (3.2) | 0 | 0 | 0 | 3 (9.7) | |
| Non-Asia subgroup | T-DXd (n = 110) | 2 (1.8) | 8 (7.3) | 1 (0.9) | 0 | 0 | 11 (10.0) |
| T-DM1 (n = 102) | 1 (1.0) | 0 | 0 | 0 | 0 | 1 (1.0) | |
Note: Patients with prior history of ILD/pneumonitis requiring steroids were excluded
aAsia subgroup defined as patients enrolled in China, Hong Kong, Japan, Republic of Korea, and Taiwan.
Abbreviations
DCO = data cut-off
;ILD = interstitial lung disease
;T-DM1 = trastuzumab emtansine
;T-DXd = trastuzumab deruxtecan
;TEAE = treatment emergent adverse event
References
1. Im S-A, Xu B, Kim, S-B, et al. Trastuzumab deruxtecan vs T-DM1 in HER2+ mBC in Asian subgroup: Results of the randomized phase 3 study DESTINY-Breast03 [presentation]. Presented at: the Japanese Society of Medical Oncology Annual Meeting 2022; February 17-19, 2022. Presentation PS2-1.
2. Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer: subgroup analyses from the randomized phase 3 study DESTINY-Breast03 [presentation and abstract]. Presented at: San Antonio Breast Cancer Symposium (SABCS) 2021 Annual Meeting; December 7-10, 2021. Cancer Res. 2022;82(suppl 4). Abs GS3-01.
3. Cortés J, Kim S-B, Chung W-P, et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386:1143-1154.
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