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Progression-Free Survival

Progression-Free Survival

Overall Survival

Overall Survival1

Overall Survival.1

Overall Survival.1

aThe boundary for statistical significance is 0.0040.

Secondary and Exploratory Efficacy Endpoints

Secondary and Exploratory Efficacy Endpoints1

Summary of Secondary and Exploratory Efficacy Endpoints in DESTINY-Breast02.1
 

T-DXd

n=406

TPC

n=202

Confirmed ORR by BICR,a n (%)
[95% CI]

283 (69.7)

[65.0-74.1]

59 (29.2)

[23.0-36.0]

 p<0.0001b
Confirmed Best Overall Response, n (%)  
     CR57 (14.0)10 (5.0)
     PR226 (55.7)49 (24.3)
     SD95 (23.4)94 (46.5)
     PD19 (4.7)26 (12.9)
     Not evaluable9 (2.2)23 (11.4)
Median DoR by BICR,months (95% CI)c19.6 (15.9-NE)8.3 (5.8-9.5)
CBR by BICR,d % (95% CI)82.3 (78.2-85.9)46.0 (39.0-53.2)
Median PFS by investigator,e months (95% CI)16.7 (14.3-19.6)5.5 (4.4-7.0)
Median PFS2,e months (95% CI)35.8 (28.4-NE)15.8 (13.5-21.0)
aProportion of patients with confirmed CR or PR assessed by BICR per mRECIST v1.1. ORR 95% CI was calculated using the Clopper-Pearson method; bTwo-sided; cBICR assessed per mRECIST v1.1; dSum of CR rate, PR rate, and >6 months SD rate; eMedian is from Kaplan-Meier analysis. CI for median is computed using the Brookmeyer-Crowley method.

Best Percentage Change in Tumor Size

Best Percentage Change in Tumor Size1

Best Percentage Change in Tumor Size by BICR in the T-DXd and TPC arms.1

Best Percentage Change in Tumor Size by BICR in the T-DXd and TPC arms.1

Note: The line at 20% indicates PD, and the line at −30% indicates a PR.

Abbreviations

BICR = blinded independent central review

;

CBR = clinical benefit rate

;

CR = complete response

;

DCO = data cut-off

;

DoR = duration of response

;

ECOG = Eastern Cooperative Oncology Group 

;

HR = hazard ratio

;

mo = months

;

NE = not evaluable

;

ORR = objective response rate

;

PD = progressive disease

;

PFS = progression-free survival 

;

PFS2 = progression-free survival after subsequent anticancer therapy

;

PR = partial response 

;

PS = performance status

;

SD = stable disease

;

T-DXd = trastuzumab deruxtecan

;

TPC = treatment of physician's choice

References

1. Krop IE, Park YH, Kim S-B, et al. Trastuzumab deruxtecan vs physician’s choice treatment in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: results from the randomized, phase 3 DESTINY Breast02 trial. Presentation presented at: San Antonio Breast Cancer Symposium 2022; December 6-10, 2022; San Antonio, TX. Presentation GS2-01.

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