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STUDY OVERVIEW EFFICACYSTUDY OVERVIEW

DATROWAY was studied in a global, phase 3 trial for 2L+ HR+/HER2− mBC1,2

  • Study overview
  • Baseline characteristics

TROPION-Breast01 was a randomized, open-label trial

Dual primary endpoints*: PFS (BICR), OS

SELECT SECONDARY ENDPOINTS: ORR, DCR, DoR, safety

ELIGIBILITY CRITERIA
  • Unresectable or metastatic HR+/HER2− breast cancer† (IHC 0, IHC 1+ or IHC 2+/ISH−)
  • Previously treated with 1 or 2 lines of chemotherapy in unresectable/metastatic setting‡
  • Progressed on and not suitable for further ET
  • ECOG PS 0 or 1
STRATIFICATION FACTORS
  • 1 or 2 lines of chemotherapy in unresectable/metastatic setting 
  • Previous CDK4/6 inhibitor use
  • Geography
732 patients were randomized 1:1 to receive either DATROWAY® (datopotamab deruxtecan-dlnk) or physician’s choice of chemotherapy732 patients were randomized 1:1 to receive either DATROWAY® (datopotamab deruxtecan-dlnk) or physician’s choice of chemotherapy
DATROWAY, 6 mg/kg IV Q3W (n=365)
Investigator’s choice of chemotherapy§ (n=367)

[eribulin, capecitabine, vinorelbine, gemcitabine]

Trop-2 testing not required for DATROWAY.1

During the study, ADCs were approved for use in HR+/HER2− mBC. After treatment discontinuation, some patients in both arms received subsequent ADC therapy2-4

*The study was considered positive if either the PFS analysis results or the OS analysis results were statistically significant.1,5

†Per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.2

‡No prior ADC use was permitted.2

§Investigator's choice of chemotherapy (ICC) was administered as follows: eribulin 1.4 mg/m2 IV on Days 1 and 8, Q3W; capecitabine, 1000 or 1250 mg/m2 orally twice daily on Days 1 to 14, Q3W; vinorelbine, 25 mg/m2 IV on Days 1 and 8, Q3W; or gemcitabine, 1000 mg/m2 IV on Days 1 and 8, Q3W.2

TROPION-Breast01 was a global trial and included patients often seen in clinical practice1,2,6,7
Baseline characteristics DATROWAY
(n=365)		 Chemotherapy
(n=367)
Age, median (range), years 56 (29–86) 54 (28-86)
Sex, % Female 99 99
Race, % White 49 46
Asian 40 41
Black or African American 1 2
Ethnicity, % Hispanic/Latino 11 12
Not Hispanic or Latino 88 87
ECOG performance status, % 0 54 60
1 45 40
Sites of metastases at study entry, % Visceral disease# 96 98
Liver metastases 75 68
Stable brain metastases 10 6
Prior endocrine therapy, %||
Unresectable/metastatic setting 88 89
Prior lines of chemotherapy, %** 1 63 61
2 37 38
Prior taxanes or anthracyclines, % Taxanes 81 81
Anthracyclines 63 65
Prior CDK4/6 inhibitor, % Yes 83 82
No 17 18
Baseline characteristics DATROWAY
(n=365)		 Chemotherapy
(n=365)
Age, median (range), years 54 (28-86) 54 (26–86)
Sex, %
Female 99 99
Race, %
White 49 46
Asian 40 41
Black or African American 1 2
Ethnicity, %
Hispanic/Latino 11 12
Not Hispanic or Latino 88 87
ECOG performance status, %
0 54 60
1 45 40
Sites of metastases at study entry, %
Visceral disease# 96 98
Liver metastases 75 68
Stable brain metastases 10 6
Prior endocrine therapy, %||
Unresectable/metastatic setting 88 89
Prior lines of chemotherapy, %**
1 63 61
2 37 38
Prior taxanes or anthracyclines, %
Taxanes 81 81
Anthracyclines 63 65
Prior CDK4/6 inhibitor, %
Yes 83 82
No 17 18

Of patients treated with DATROWAY, 25% were ≥65 and 5% were ≥75 years of age.1

#Visceral metastases includes all sites except bone.6

||95% of patients in the DATROWAY arm and 96% in the chemotherapy arm had received any prior hormonal therapy, including the adjuvant setting.2

**One patient in the DATROWAY arm had received three previous lines of chemotherapy and one patient in the chemotherapy arm had received four previous lines of chemotherapy.2

ADC, antibody-drug conjugate; ALT, alanine aminotransferase; ARs, adverse reactions; AST, aspartate aminotransferase; BICR, blinded independent central review; CDK, cyclin-dependent kinase; CI, confidence interval; ET, endocrine therapy; HER2−, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; IV, intravenous; mBC, metastatic breast cancer; mPFS, median progression-free survival; OS, overall survival; PFS, progression-free survival; Q3W, once every three weeks; TRAEs, treatment-related adverse events; Trop-2, trophoblast cell-surface antigen 2.

2L+, second-line or later; ADC, antibody-drug conjugate; ASCO/CAP, American Society of Clinical Oncology/College of American Pathologists; BICR, blinded independent central review; CDK, cyclin-dependent kinase; DCR, disease control rate; DoR, duration of response; ECOG, Eastern Cooperative Oncology Group; ET, endocrine therapy; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; ICC, investigator's choice of chemotherapy; IHC, immunohistochemistry; ISH, in situ hybridization; IV, intravenous; mBC, metastatic breast cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PS, performance status; Q3W, once every three weeks; Trop-2, trophoblast cell-surface antigen 2.

BICR, blinded independent central review; CDK, cyclin-dependent kinase; Cl, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration of response; ECOG, Eastern Cooperative Oncology Group; ET, endocrine therapy; HER2−, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; mBC, metastatic breast cancer; mOS, median overall survival; mPFS, median progression-free survival; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumours; SD, stable disease.

ADC, antibody-drug conjugate; ALT, alanine aminotransferase; ARs, adverse reactions; AST, aspartate aminotransferase; CLcr, creatinine clearance; G-CSF, granulocyte-colony stimulating factor; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; ILD, interstitial lung disease; mBC, metastatic breast cancer; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q3W, once every three weeks; TRAEs, treatment-related adverse events; Trop-2, trophoblast cell-surface antigen 2.

ADC, antibody-drug conjugate; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; IHC, immunohistochemistry; ISH, in situ hybridization; IV, intravenous; Q3W, once every three weeks; Trop-2, trophoblast cell-surface antigen 2.

5-HT3, 5-hydroxytryptamine type 3; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; ILD, interstitial lung disease; Trop-2, trophoblast cell-surface antigen 2.

DNA, deoxyribonucleic acid; HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; mAb, monoclonal antibody; Trop-2, trophoblast cell-surface antigen 2.

HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive.

HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive.

HER2−, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive.

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Efficacy data

TROPION-Breast01 trial results in adults with 
previously treated HR+/HER2− mBC1


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