dslogo
azlogo

DESTINY-Breast01: Safety Results (March 26, 2021 DCO Date)

Overall Safety Summary

Overall Safety Summary

  • The overall safety profile of T-DXd is consistent with what has been previously reported1
  • T-DXd continues to demonstrate a generally tolerable safety profile1
    • Median duration of follow-up, 26.5 months (range, 0.7-39.1 months)
Overall Safety Summary.1-3 
Type of Adverse Event, n (%)a

August 2019 DCO
T-DXd 5.4 mg/kg

(N=184)

June 2020 DCO
T-DXd 5.4 mg/kg

(N=184)

March 2021 DCO
T-DXd 5.4 mg/kg

(N=184)

Any TEAE
    Drug-related		183 (99.5)
183 (99.5)		183 (99.5)
183 (99.5)

183 (99.5)

183 (99.5)

TEAE grade ≥3

    Drug-related

105 (57.1)
89 (48.4)		113 (61.4)
97 (52.7)

116 (63.0)

99 (53.8)

Dose adjustments

 

TEAE associated with discontinuation

    Drug-related

28 (15.2)

27 (14.7)

34 (18.5)

33 (17.9)

35 (19.0)

33 (17.9)

TEAE associated with dose reduction

    Drug-related

43 (23.4)

40 (21.7)

44 (23.9)

     39 (21.2)b

46 (25.0)

43 (23.4)

TEAE associated with dose interruption

    Drug-related

65 (35.3)

53 (28.8)

75 (40.8)

60 (32.6)

77 (41.8)

60 (32.6)

Death

 

TEAE associated with deathc

    Drug-related

9 (4.9)

2 (1.1)

10 (5.4)

3 (1.6)

10 (5.4)

3 (1.6)

aRelationship to study drug was determined by the treating investigator; bBased on updated investigator assessment; cEach of the following TEAEs was associated with a fatal outcome: respiratory failure, acute respiratory failure, disease progression, general physical health deterioration, lymphangitis, pneumonia, pneumonitis, shock hemorrhagic; 1 patient had 2 TEAEs associated with death: acute kidney injury and acute hepatic failure. .

Adverse Events of Special Interest: ILD/Pneumonitis

Adverse Events of Special Interest: ILD/Pneumonitis1

Adverse Events of Special Interest: ILD/Pneumonitis.1
ILD, n (%)a

August 2019 DCO
T-DXd 5.4 mg/kg

(N=184)

June 2020 DCO
T-DXd 5.4 mg/kg

(N=184)

March 2021 DCO
T-DXd 5.4 mg/kg

(N=184)

Grade 15 (2.7)6 (3.3)7 (3.8)
Grade 215 (8.2)16 (8.7)16 (8.7)
Grade 31 (0.5)1 (0.5)1 (0.5)
Grade 4000
Grade 54 (2.2)5 (2.7)5 (2.7)
Any grade/total25 (13.6)28 (15.2)29 (15.8)
aAs determined by an independent interstitial lung disease adjudication committee. At data cutoff, 1 grade 1 event and 1 grade 3 event were pending adjudication.
  • Since the June 2020 DCO, 1 new case of grade 1 T-DXd–related ILD/pneumonitis as determined by an independent adjudication committee was reported1 
  • With ongoing follow-up, there were no additional reported cases of grade ≥3 ILD/pneumonitis events1 

Abbreviations

DCO = data cut-off

;

ILD = interstitial lung disease

;

T-DXd = trastuzumab deruxtecan

;

TEAE = treatment-emergent adverse event

References

1. Saura C, Modi S, Krop I, et al. Trastuzumab Deruxtecan (T-DXd) in patients with HER2-positive metastatic breast cancer: updated survival results from a phase 2 trial (DESTINY-Breast01) [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) 2021 Annual Meeting; September 16-21, 2021. Ann Oncol. 2021;32(suppl 5). Abstract 279P.
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.
3. Modi S, Saura C, Yamashita T, et al. Updated results from DESTINY-Breast01, a phase 2 trial of trastuzumab deruxtecan (T-DXd) in HER2-positive metastatic breast cancer [poster and abstract]. Poster presented at: San Antonio Breast Cancer Symposium; December 8-11, 2020. Cancer Res. 2021;81(suppl 4). Abstract PD3-06.

Please note that this content may contain some data and/or patient populations which are considered off-label in your country. Providing this information does not constitute any recommendation for use. AstraZeneca is providing this material as an information service and professional courtesy. 

To help us improve our content for health care professionals, please take this short survey.

Feedback Survey

©2023 AstraZeneca. All rights reserved.