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

Overall Summary of Efficacy Results

Overall Summary of Efficacy Results1

Efficacy Summary.1
Intent-to-treat analysis

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)

Median duration of follow up (range), months11.1 (0.7-19.9)20.5 (0.7-31.4)26.5 (0.7-39.1)
Patients remaining on treatment, n (%)79 (42.9)37 (20.1)28 (15.2)

Confirmed ORRa by ICR, n (%)

95% CI

112 (60.9)

53.4-68.0

113b (61.4)

54.0-68.5

114 (62.0)

54.5-69.0

  • CR
11 (6.0)12 (6.5)13 (7.1)
  • PR
101 (54.9)101 (54.9)101 (54.9)
  • SD
67 (36.4)66 (35.9)65 (35.3)
  • PD
3 (1.6)3 (1.6)3 (1.6)
NE2 (1.1)2 (1.1)2 (1.1)
Median DOR (95% CI), months14.8 (13.8-16.920.8b (15.0-NE)18.2 (15.0-NE)
Median time to response (95% CI), months1.6 (1.4-2.7)1.6 (1.4-2.7)1.6 (1.4-2.7)
Median PFS (95% CI), months16.4 (12.7-NE)19.4 (14.1-NE)19.4 (14.1-25.0)
Median OS (95% CI), monthsNE (NE-NE)24.6 (23.1-NE)29.1 (24.6-36.1)
aORR = CR + PR; bOne patient had a PR prior to the June 8, 2020 cutoff date that was confirmed after the cutoff date. The patient had a confirmed best overall response of PR on the first PR date in the central data but was not included in the analysis of duration of response..

Antitumor Response

Best Percent Change From Baseline in Target Lesions1

Best Percent Change From Baseline in Target Lesions.1

Best Percent Change From Baseline in Target Lesions.1

By independent central review. A total of 169 patients from the enrolled analysis set (N=184) had both baseline and postbaseline target lesion assessments by independent central review and are included in this analysis.

Kaplan-Meier Analyses

Kaplan-Meier Analyses1

Abbreviations

CR = complete response

;

DCO = data cut-off

;

DOR = duration of response

;

ICR = independent central review

;

NE = not evaluable

;

ORR = objective response rate

;

OS = overall survival 

;

PD = progressive disease

;

PFS = progression-free survival 

;

PR = partial response 

;

SD = stable disease

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.

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