Patient Characteristics

DESTINY-Breast02: Patients Demographics and Baseline Characteristics (June 30, 2022 DCO Date)

Patient Disposition
Baseline Characteristics
Prior Therapies

Patient Disposition

Patient Disposition¹

Patient Disposition.¹

	T-DXd n=406	TPC n=202
Patients Randomized, n (%)	406	202
Randomized but not treated	2 (0.5)	7 (3.5)
Treatment status, n (%)
Ongoing treatment^a	94 (23.3)	5 (2.6)
Treatment discontinuation^a	310 (76.7)	190 (97.4)
Primary reason for discontinuation, n (%)
Progressive disease^b	174 (43.1)	141 (72.3)
Adverse event	74 (18.3)	14 (7.2)
Patient withdrawal	30 (7.4)	17 (8.7)
Clinical progression	23 (5.7)	15 (7.7)
Death	4 (1.0)	1 (0.5)
Physician decision	2 (0.5)	1 (0.5)
Lost to follow-up	1 (0.2)	0
Other	1 (0.2)	0
Protocol deviation	1 (0.2)	1 (0.5)

^aPercentage calculated using the number of treated patients as denominator; ^bPer RECIST v1.1.

Baseline Characteristics

Baseline Characteristics¹

Baseline Characteristics for Patients Enrolled in DESTINY-Breast02.¹

Baseline Characteristic	T‑DXd (n=406)	TPC (n=202)
Age, median, years (range)	54.2 (22.4-88.5)	54.7 (24.7-86.5)
Age, n (%)
<65 years	321 (79.1)	164 (81.2)
≥65 years	85 (20.9)	38 (18.8)
Female, n (%)	403 (99.3)	200 (99.0)
Region, n (%)
Asia	112 (27.6)	52 (25.7)
Europe	152 (37.4)	78 (38.6)
North America	41 (10.1)	23 (11.4)
Rest of world	101 (24.9)	49 (24.3)
HER2 status (IHC),^a n (%)
3+	326 (80.3)	159 (78.7)
2+ (ISH+)	79 (19.5)	41 (20.8)
2+ (ISH- or non-evaluable)	1 (0.2)	1 (0.5)
1+ (ISH+)	0	1 (0.5)
ECOG PS score, n (%)
0	228 (56.2)	121 (59.9)
1	177 (43.6)	81 (40.1)
2	1 (0.2)	0
HR,^b n (%)
Positive	238 (58.6)	118 (58.4)
Negative	165 (40.6)	83 (41.1)
BM at baseline,^c n (%)
Yes	74 (18.2)	36 (17.8)
No	332 (81.8)	166 (82.2)
Visceral disease, n (%)
Yes	316 (77.8)	160 (79.2)
No	90 (22.2)	42 (20.8)

^aHER2 status as evaluated by central laboratory testing; ^bThree (0.7%) patients in the T-DXd arm and 1 (0.5%) patient in the TPC arm had indeterminate hormone receptor status (neither estrogen receptors nor progesterone receptors positive and estrogen receptors indeterminate or progesterone receptors indeterminate) based on factors reported from EDC; ^cPatients with clinically inactive brain metastases and patients with treated brain metastases that were no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants could be included.

Prior Therapies

Prior Therapies¹

Prior Therapies for Patients Enrolled in DESTINY-Breast02.¹

Prior Treatment	T-DXd (n=406)	TPC (n=202)
Previous treatment for BC, n (%)	406 (100)	202 (100)
Prior lines of therapy in the metastatic setting,^a n (%)
0	2 (0.5)	0
1	18 (4.4)	12 (5.9)
2	192 (47.3)	92 (45.5)
3	123 (30.3)	63 (31.2)
4	42 (10.3)	13 (6.4)
≥5	29 (7.1)	22 (10.9)
Median number of prior lines of therapy,^a (range)	2 (0-10)	2 (1-8)
Prior systemic cancer therapy, n (%)
Trastuzumab	404 (99.5)	202 (100)
T-DM1	404 (99.5)	202 (100
Taxane	386 (95.1)	197 (97.5)
Pertuzumab	318 (78.3)	156 (77.2)
Other Systemic therapy	289 (71.2)	157 (77.7)
Hormone therapy	164 (40.4)	87 (43.1)
Anti-HER2 TKI	26 (6.4)	17 (8.4)
Other anti-HER2 therapy (except HER2 TKI)	11 (2.7)	6 (3.0)

^aIncludes regimens indicated for advanced/metastatic disease or rapid progression within 6 months of (neo)adjuvant (12 months for pertuzumab) therapy. Line of therapy does not include hormone therapy.

Abbreviations

BC = breast cancer

;

BM = brain metastases

;

DCO = data cut-off

;

ECOG = Eastern Cooperative Oncology Group

;

EDC = electronic data capture

;

HER2 = human epidermal growth factor receptor 2

;

HR = hormone receptor

;

IHC = immunohistochemistry

;

PS = performance status

;

RECIST = Response Evaluation Criteria in Solid Tumors

;

T-DM1 = trastuzumab emtansine

;

T-DXd = trastuzumab deruxtecan

;

TKI = tyrosine kinase inhibitor

;

TPC = treatment of physician's choice

References

1. Krop IE, Park YH, Kim S-B, et al. Trastuzumab deruxtecan vs physician’s choice treatment in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: results from the randomized, phase 3 DESTINY Breast02 trial. Presentation presented at: San Antonio Breast Cancer Symposium 2022; December 6-10, 2022; San Antonio, TX. Presentation GS2-01.

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