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STUDY OVERVIEW STUDY OVERVIEW
  • Study design
  • Baseline characteristics

TROPION-Breast02 was a global study in 1L mTNBC of adults who were not candidates for PD-1/PD-L1 inhibitors1,2

A phase 3, open-label, randomized, multicenter study1,3,4

ELIGIBILITY CRITERIA*
Previously untreated, unresectable, or metastatic TNBC
Not a candidate for PD-1/PD-L1 inhibitor therapy, defined as:
PD-L1–negative, or
PD-L1–positive and have:
relapsed after prior PD-1/PD-L1 inhibitor therapy for early stage breast cancer, or
comorbidities precluding PD-1/PD-L1 inhibitor therapy, or
no regulatory access to PD-1/PD-L1 inhibitor therapy
ECOG PS 0 or 1
No minimum DFI†
N=644
1:1
DATROWAY
6 mg/kg IV Q3W
(n=323)
Investigator's choice of chemotherapy‡
Paclitaxel, nab-paclitaxel, capecitabine, eribulin, carboplatin
(n=321)

DUAL PRIMARY ENDPOINTS:

OS, PFS (BICR)

SELECT SECONDARY ENDPOINTS:

PFS (investigator), ORR, DoR, Safety
After progression, patients could receive best standard of care (approved ADCs or chemotherapy) at the investigator's discretion.§
Of the patients who received subsequent therapy in any line, 41% in the chemotherapy arm and 21% in the DATROWAY arm received a subsequent ADC

STRATIFICATION FACTORS

Geographic location (USA/Canada/Europe or other geographic regions)
DFI history (de novo or ≤12 months or >12 months)||
PD-L1 status (positive or negative)

SELECT EXCLUSION CRITERIA

History of ILD/pneumonitis requiring treatment with steroids
Ongoing ILD/pneumonitis
Clinically significant corneal disease at screening
ECOG PS >1

TROPION-Breast02 was the first pivotal study for DATROWAY in mTNBC5

*Additional eligibility criteria: no prior CTx or targeted systemic therapy for locally recurrent inoperable or mBC.3

†DFI defined as time between date of completion of treatment with curative intent and date of first documented local or distant disease recurrence.4

‡If no prior taxane, or prior taxane in the (neo)adjuvant setting and DFI >12 months: paclitaxel or nab-paclitaxel; if prior taxane and DFI ≤12 months: capecitabine, carboplatin, or eribulin.4

§In the DATROWAY vs ICC arm, 65% vs 72% of patients received any subsequent therapy in any treatment line.4

||The number of patients with DFI ≤12 months was capped at 20% of randomized patients.4

1L, first-line; ADC, antibody-drug conjugate; BICR, Blinded Independent Central Review; CPS, combined positive score; CTx, chemotherapy; DFI, disease-free interval; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ICC, investigator’s choice of chemotherapy; ILD, interstitial lung disease; IV, intravenous; mBC, metastatic breast cancer; mTNBC, metastatic triple-negative breast cancer; ORR, objective response rate; OS, overall survival; PD-1, programmed cell death protein 1; PD-L1, programmed cell death-ligand 1; PFS, progression-free survival; Q3W, once every 3 weeks; TNBC, triple-negative breast cancer.

TROPION-Breast02 evaluated a broad patient
population, including those with aggressive disease4*

Baseline characteristics1,4 DATROWAY
(n=323)		 Chemotherapy
(n=321)
Age, median (range), years 56 (27-85) 57 (23-83)
Female, % 100 99
Ethnicity, % Black or African American 4 4
Asian 47 41
White 41 48
Other† 9 7
Ethnicity, % Hispanic or Latino 14 16
Not Hispanic or Latino 84 83
Missing 2 1
Geographic region, % US, Canada, Europe 37 37
Other geographic regions 63 63
ECOG PS, % 0 60 57
1 40 43
DFI history, % de novo 34 34
Prior DFI 0-12 months§ 21 21
Prior DFI 0-6 months
 15 16
Prior DFI >12 months§ 46 45
PD-L1 status,‡ % Low (CPS <10) 89 91
High (CPS ≥10) 11 9
Metastases, %
Visceral
 78 73
Liver 29 31
Stable brain||
 11 9
Number of metastatic sites, % <3 64 67
≥3 36 33
Preselected choice of chemotherapy, % Nab-paclitaxel 56 54
Paclitaxel 25 29
Eribulin mesylate/eribulin 13 12
Carboplatin 3 4
Capecitabine 2 2
Baseline characteristics1,4 DATROWAY
(n=323)		 Chemotherapy
(n=321)
Age, years
Median (range), years 56 (27-85) 57 (23-83)
Sex, %
Female, % 100 99
Ethnicity, %
Black or African American 4 4
Asian 47 41
White 41 48
Other† 9 7
Ethnicity, %
Hispanic or Latino 14 16
Not Hispanic or Latino 84 83
Missing 2 1
Geographic region, %
US, Canada, Europe 37 37
Other geographic regions 63 63
ECOG PS, %
0 60 57
1 40 43
DFI history, %
de novo 34 34
Prior DFI 0-12 months§ 21 21
Prior DFI 0-6 months
 15 16
Prior DFI >12 months§ 46 45
PD-L1 status,‡ %
Low (CPS <10) 89 91
High (CPS ≥10) 11 9
Metastases, %
Visceral 78 73
Liver 29 31
Stable brain|| 11 9
Number of metastatic sites, %
<3 64 67
≥3 36 33
Preselected choice of chemotherapy, %
Nab-paclitaxel 56 54
Paclitaxel 25 29
Eribulin mesylate/eribulin 13 12
Carboplatin 3 4
Capecitabine 2 2

TROPION-Breast02 included patients with DFI <6 months, who are often excluded from 1L mTNBC pivotal trials4,6,7

*Aggressive disease was defined as prior DFI of <6 months, visceral metastases, or stable brain metastases.8-10

†Including not reported.4

‡PD-L1 testing was performed prior to randomization by a sponsor-designated central laboratory using the PD-L1 immunohistochemistry 22C3 pharmDx assay (Dako North America, Inc., Carpinteria, CA) to determine PD-L1 combined positive score.2,4

§Prior cancer therapy was received by 67% of patients, including taxanes (58%), nitrogen mustards (57%), anthracyclines (56%), pyrimidine analogues (27%), platinum compounds (16%), and PD-(L)1 inhibitors (5%).4

||Patients with asymptomatic, stable brain metastases were permitted in the study.1,3

1L, first-line; ADC, antibody-drug conjugate; BICR, Blinded Independent Central Review; CPS, combined positive score; CTx, chemotherapy; DFI, disease-free interval; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ICC, investigator’s choice of chemotherapy; ILD, interstitial lung disease; IV, intravenous; mBC, metastatic breast cancer; mTNBC, metastatic triple-negative breast cancer; ORR, objective response rate; OS, overall survival; PD-1, programmed cell death protein 1; PD-L1, programmed cell death-ligand 1; PFS, progression-free survival; Q3W, once every 3 weeks; TNBC, triple-negative breast cancer.

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Efficacy data

Efficacy of DATROWAY was evaluated in the TROPION-Breast02 study1

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