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DESTINY-Breast01: BM Subgroup Safety Results (August 1, 2019 DCO Date)

Safety Summary1

  • Median treatment duration1
    • All patients: 10.0 months (range, 0.7-20.5)
    • BM subgroup: 11.0 months (range, 0.7-20.2)
    • Non-BM subgroup: 9.9 months (range, 0.7-20.5)
  • The TEAEs in the BM subgroup were generally consistent with the overall patient population and were predominantly gastrointestinal or hematologic in nature1
  • Drug related TEAEs associated with discontinuation occurred in 2 patients (8.3%) with a history of BMs and in 25 (15.6%) patients without1
    • Pneumonitis (n=11) and ILD (n=5) were the predominant causes for discontinuation among patients in then non-BM subgroup
Safety Summary.1
Type of Adverse Event, n (%)aBM
Subgroup
(n=24)		Non-BM Subgroup
(n=160)		 All
Patients
(N=184)
Any TEAE
    Drug related

24 (100)

24 (100)

159 (99.4)
159 (99.4)		183 (99.5)
183 (99.5)

TEAE grade ≥3

    Drug related

13 (54.2)

10 (41.7)

92 (57.5)

79 (49.4)

105 (57.1)
89 (48.4)

Serious TEAE

    Drug related

3 (12.5)

1 (4.2)

39 (24.4)

22 (13.8)

42 (22.8)

23 (12.5)

TEAE associated with discontinuation

    Drug related

2 (8.3)

2 (8.3)

26 (16.3)

25 (15.6)

28 (15.2)

27 (14.7)

TEAE associated with dose reduction

    Drug related

5 (20.8)

4 (16.7)

38 (23.4)

36 (22.5)

43 (23.4)

40 (21.7)

TEAE associated with dose interruption

    Drug related

9 (37.5)

8 (33.3)

56 (35.0)

45 (28.1)

65 (35.3)

53 (28.8)

TEAE associated with deathb

    Drug related

2 (8.3)

1 (4.2)

7 (4.4)

1 (0.6)

9 (4.9)

2 (1.1)

aRelationship to study drug was determined by the treating investigator; bEach of the following TEAEs was associated with a fatal outcome: in the BM subgroup, respiratory failure and disease progression (each, n = 1); in the non-BM subgroup, acute respiratory failure, general physical health deterioration, lymphangitis, pneumonia, pneumonitis, and shock hemorrhagic (each n = 1) and 1 patient had 2 TEAEs associated with death (acute kidney injury and acute hepatic failure).

Abbreviations

BM = brain metastases

;

TEAE = treatment emergent adverse event

;

DCO = data cut-off

;

ILD = interstitial lung disease

References

1. Jerusalem G, Park Y, Yamashita S, et al. Trastuzumab deruxtecan in HER2-positive metastatic breast cancer patients with brain metastases: A DESTINY-Breast01 subgroup analysis [article and supplementary appendix]. Cancer Discov. 2022;12(12):2754-2762

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