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Efficacy by Number of Lines of Prior Cancer Systemic Therapy

Efficacy by Number of Lines of Prior Cancer Systemic Therapy1

Efficacy by Number of Lines of Prior Cancer Systemic Therapy.1

Lines of Prior Cancer Systemic Therapya

2

(n=30)

3

(n=24)

4

(n=26)

5

(n=28)

≥ 6

(n=76)

Confirmed ORR (CR + PR) by ICR, n (%)b

23 (76.7)

95% CI, 57.7-90.1

15 (62.5)

95% CI, 40.6-81.2

14 (53.8)

95% CI, 33.4-73.4

18 (64.3)

95% CI, 44.1-81.4

42 (55.3)

95% CI, 43.4-66.7

    CR5 (16.7)03 (11.5)3 (10.7)0
    PR18 (60.0)15 (62.5)11 (42.3)15 (53.6)42 (55.3)
    SD6 (20.0)7 (29.2)12 (46.2)10 (35.7)32 (42.1)
    NE1 (3.3)0001 (1.3)
    PD02 (8.3)001 (1.3)

Post hoc analysis


aSystemic therapies in the advanced or metastatic setting, including hormone therapy; bData are for all randomized patients who received ≥ 1 dose of T-DXd 5.4 mg/kg and had measurable tumors based on ICR at baseline (N = 184).

ORR Across Subgroups

ORR Across Subgroups2

Consistent ORR Observed Across Subgroups2

Consistent ORR Observed Across Subgroups2

aPatients who received T-DXd 5.4 mg/kg.

Multivariate Analyses of Clinical Variables

Multivariate Analyses of Clinical Variables1

  • Clinical variables associated with better ORR, DOR, or median PFS in multivariate analyses included HER2 IHC 3+ status, pertuzumab given in the first or second line, fewer prior treatment regimens (continuous variable), and renal and hepatic function1
  • All other variables tested did not significantly impact efficacy outcomes compared to the overall population1
Multivariate Analyses of Clinical Variables.1


Patients who received
T-DXd 5.4 mg/kg (N=184)
Dependent VariableClinical VariableHazard Ratio (95% CI)p Value
DOR by ICRHER2 IHC status (IHC 3+, other)0.341 (0.133-0.874)0.0250
Hepatic impairment at baseline (normal, mild to moderate)0.508 (0.227-1.138)0.0998
Confirmed ORR by ICRPrior pertuzumab in first or second line in advanced/metastatic BC (yes, no)0.442 (0.210-0.933)0.0321


PFS by ICR

No. of prior regimens1.103 (1.029-1.182)0.0055
Renal impairment at baseline (normal, mild to moderate)2.100 (1.162-3.793)0.0139
Hepatic impairment at baseline (normal, mild to moderate)0.484 (0.270-0.867)0.0147

The α for entry was 0.3 and the α for stay was 0.1


Abbreviations

BC = breast cancer

;

CR = complete response

;

DCO = data cut-off

;

DOR = duration of response

;

ECOG = Eastern Cooperative Oncology Group 

;

HER2 = human epidermal growth factor receptor 2

;

ICR = independent central review

;

IHC = immunohistochemistry

;

NE = not evaluable

;

ORR = objective response rate

;

PD = progressive disease

;

PFS = progression-free survival 

;

PR = partial response 

;

SD = stable disease

;

T-DXd = trastuzumab deruxtecan

References

1. Modi S, Andre F, Krop IE, et al. Trastuzumab deruxtecan for HER2-positive metastatic breast cancer: DESTINY-Breast01 subgroup analysis [poster and abstract]. Poster presented at: 2020 Americam Society of Clinical Oncology (ASCO) Virtual Scientific Program. J Clin Oncol. 2020; 38(suppl 15): Abs 1036.
2. Modi S, Saura C, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med 2020;382:610-621.

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