Patient Characteristics

DESTINY-Breast03: Patients Demographics and Baseline Characteristics (November 20, 2023 DCO Date)

Patients Treated by Region
Patient Disposition
Baseline Characteristics
Prior Therapies

Patients Treated by Region

Patients Treated by Region^1,2

Patient Disposition

Patient Disposition³

Efficacy analysis was conducted in the full analysis set (all patients who were randomly assigned to a treatment group), and safety analysis was conducted in the safety analysis set (all patients who were randomly assigned and received at least one dose of T-DXd or T-DM1).

Median duration of follow-up

T-DXd group: 43.0 months (range, 0.0-62.9 months)
T-DM1 group: 35.4 months (range, 0.0-60.9 months)

Baseline Characteristics

Baseline Characteristics^3,4

Demographics and Baseline Characteristics

Characteristic	T‑DXd 5.4 mg/kg IV Q3W n=261	T-DM1 3.6 mg/kg IV Q3W n=263
Age, median (range), years	54.3 (27.9-83.1)	54.2 (20.2-83.0)
Sex, n (%)
Female	260 (99.6)	262 (99.6)
Male	1 (0.4)	1 (0.4)
Region, n (%)
Asia	149 (57.1)	160 (60.8)
Europe	54 (20.7)	50 (19.0)
North America	17 (6.5)	17 (6.5)
Australia and South America	41 (15.7)	36 (13.7)
Race, n (%)
White	71 (27.2)	72 (27.4)
Black or African American	10 (3.8)	9 (3.4)
Asian	152 (58.2)	162 (61.6)
Other^a	28 (10.7)	20 (7.6)
Ethnicity, n (%)
Hispanic/Latino	29 (11.1)	29 (11.0)
Non-Hispanic/Non-Latino	203 (77.8)	209 (79.5)
Unknown	5 (1.9)	6 (2.3)
Data not collected	24 (9.2)	19 (7.2)
HER2 IHC status, n (%)
IHC 3+	234 (89.7)	232 (88.2)
IHC 2+	25 (9.6)	30 (11.4)
IHC 1+	1 (0.4)	0
Not evaluable	1 (0.4)	1 (0.4)
HER2 amplification status, n (%)
ISH+	24 (9.2)	29 (11.0)
ISH-	2 (0.8)	2 (0.8)
Missing	235 (90.0)	232 (88.2)
ECOG PS score, n (%)
0	154 (59.0)	175 (66.5)
1	106 (40.6)	87 (33.1)
Missing	1 (0.4)	1 (0.4)
Positive HR status,^b n (%)	131 (50.2)	134 (51.0)
History of CNS metastases, n (%)	62 (23.8)
CNS metastases at baseline, n (%)	43 (16.5)	52 (19.8)
History of visceral disease, n (%)	184 (70.5)	39 (14.8)
Liver metastases at baseline, n (%)	91 (34.9)	185 (70.3)
Lung metastases at baseline, n (%)	113 (43.3)	76 (28.9)
Renal impairment at baseline,^c n (%)
Within normal range	135 (51.7)	130 (50.2)
Mild impairment	97 (37.2)	105 (39.9)
Moderate impairment	28 (10.7)	25 (9.5)
Missing	1 (0.4)	1 (0.4)

^aIncludes patients who reported multiple races; ^bPatients’ tumors were considered hormone receptor positive if they were estrogen receptor positive and/or progesterone receptor positive; ^cWithin normal range (creatinine clearance ≥90 mL/min), mild impairment (creatinine clearance ≥60 and <90 mL/min), and moderate impairment (creatinine clearance ≥30 and <60 mL/min), as calculated using the Cockcroft-Gault equation ([{140 – age in years} × {actual weight in kg}] divided by [{72 × serum creatinine in mg/dL} multiply by 0.85 if female]).

Prior Therapies

Prior Therapies^3,4

Prior Therapies

Characteristic	T‑DXd n = 261	T‑DM1 n = 263
Any previous systemic cancer therapy,^a n (%)	260 (99.6)	262 (99.6)
Trastuzumab	260 (99.6)	262 (99.6)
T-DM1	1 (0.4)	0
Pertuzumab	162 (62.1)	158 (60.1)
Taxane and trastuzumab	260 (99.6)	262 (99.6)
Other anti-HER2 therapy	42 (16.1)	38 (14.4)
HER2 TKI	42 (16.1)	36 (13.7)
Other anti-HER2 antibody or ADC	2 (0.8)	3 (1.1)
Hormone therapy	109 (41.8)	112 (42.6)
Other systemic therapy not hormone or HER2-directed	183 (70.1)	177 (67.3)
Number of prior lines of therapy in the metastatic setting, median (range)	2 (0-16)	2 (0-15)
Previous treatment for metastatic breast cancer, n (%)	240 (92.0)	234 (89.0)
Prior lines of therapy in the metastatic setting,^{^b} n (%)
0	1 (0.4)	1 (0.4)
1	108 (41.4)	102 (38.8)
2	60 (23.0)	64 (24.3)
3	44 (16.9)	45 (17.1)
4	15 (5.7)	23 (8.7)
≥5	33 (12.6)	28 (10.6)

^aTwo patients (one in each treatment group) were randomized in error and the previous cancer systemic therapy case report form was not completed. One patient who had previously received treatment with T-DM1 was enrolled in error in the T‐DXd group; ^bIncludes regimens indicated for advanced/metastatic or early progression within 6 months of regimen for (neo)adjuvant (12 months for pertuzumab).

Abbreviations

ADC = antibody-drug conjugate

;

CNS = central nervous system

;

DCO = data cut-off

;

ECOG PS = Eastern Cooperative Oncology Group Performance Status

;

HER2 = human epidermal growth factor receptor 2

;

HR = hormone receptor

;

IHC = immunohistochemistry

;

ISH = in situ hybridization

;

IV = intravenous

;

Q3W = every 3 weeks

;

RoW = rest of world

;

T-DM1 = trastuzumab emtansine

;

T-DXd = trastuzumab deruxtecan

;

TKI = tyrosine kinase inhibitor

References

1. Hurvitz SA, Hegg R, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial [article]. The Lancet. 2022;401(10371):105-117.

2. Hurvitz SA, Hegg R, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated results of the randomized, phase 3 study DESTINY-Breast03 [presentation and supplementary material]. Presented at: San Antonio Breast Cancer Symposium (SABCS) 2022 Annual Meeting; December 6-10, 2022.

3. Cortés J, Hurvitz SA, Im S-A, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from the randomized, phase 3 DESTINY-Breast03 trial. Nat Med. 2024.

4. Hamilton E, Hurvitz SA, Im S-A, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated survival results from the randomized, phase 3, DESTINY-Breast03 trial. Presented at: American Society for Clinical Oncology; May 31- June 4, 2024. Poster 1025. [Supplement].

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Document ID: 8db67364-6c52-4ea0-b987-9d4900884ec2
Last updated: 27-June-2024

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