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DESTINY-Breast02: Safety Results (June 30, 2022 DCO Date) 

Overall Safety Summary

Overall Safety Summary1

  • The safety analysis set included all randomized patients who received at least 1 dose of study treatment (T‑DXd arm [n=404]; TPC arm [n=195]). At June 30, 2022 DCO, the median treatment duration was 11.3 months with T‑DXd and approximately 4.5 months with TPC.1
  • Most patients experienced a TEAE (99.8% with T‑DXd and 94.9% with TPC).1 
  • The most common drug-related TEAEs associated with drug discontinuation for T‑DXd were pneumonitis (6.2%) and ILD (3.2%).1 
  • The most common drug-related TEAE associated with treatment discontinuation with TPC was palmar-plantar erythrodysesthesia (1.5%).1  
Overall Safety Summary.1
Type of Adverse Event, n (%)

T-DXd

n=404a

TPC

n=195a

Any-grade TEAE403 (99.8)185 (94.9)
     Drug-related394 (97.5)180 (92.3)
Grade ≥3 TEAEs213 (52.7)86 (44.1)
     Drug-related167 (41.3)60 (30.8)
Serious TEAEs103 (25.5)46 (23.6)
     Drug-related46 (11.4)15 (7.7)
TEAEs associated with drug discontinuations80 (19.8)19 (9.7)
     Drug-related58 (14.4)10 (5.1)
TEAEs associated with drug interruptions183 (45.3)90 (46.2)
     Drug-related132 (32.7)76 (39.0)
TEAEs associated with dose reductions102 (25.2)89 (45.6)
     Drug-related95 (23.5)89 (45.6)
TEAEs associated with an outcome of death11 (2.7)b7 (3.6)c
     Drug-related4 (1.0)d0
aThe safety analysis set includes all randomly assigned patients who received at least 1 dose of study treatment; bTEAEs associated with an outcome of death included pneumonitis (n=2), acute myeloid leukemia (n=1), brain edema (n=1), COVID-19 (n=1), disease progression (n=1), hemorrhage (n=1), hepatitis B (n=1), malignant pleural effusion (n=1), pneumonia (n=1), and vasogenic cerebral edema (n=1); cTEAEs associated with an outcome of death included disease progression (n=4), cardiac arrest (n=1), metastases to meninges (n=1), and pericardial effusion (n=1); dDrug-related TEAEs associated with an outcome of death included pneumonitis (n=2), acute myeloid leukemia (n=1), and pneumonia (n=1).

Most Common TEAE

Most Common TEAE1

Most Common TEAEs (>15% of Patients in Either Treatment Arm).1

Most Common TEAEs (>15% of Patients in Either Treatment Arm).1

Adverse Events of Special Interest

Adverse Events of Special Interest1

Adjudicated ILD/Pneumonitis1

Adjudicated Drug-Related ILD.1
 Adjudicated as Drug-Related ILDa
n (%)Grade 1Grade 2Grade 3Grade 4Grade 5Any Grade

T-DXd

(n=404)

11 (2.7)26 (6.4)3 (0.7)02 (0.5)42 (10.4)

TPC

(n=195)

001 (0.5)001 (0.5)
aThe safety analysis set includes all randomly assigned patients who received at least 1 dose of study treatment.

Left Ventricular Dysfunction 1

  • Eighteen (4.5%) patients in the T-DXd arm experienced a LV dysfunction event, with 2 (0.5%) experiencing a grade ≥3 event. Three (1.5%) patients in the TPC arm experienced LV dysfunction, with 1 (0.5%) experiencing a grade ≥3 event.1
  • In the T-DXd arm, 17 patients experienced decreased ejection fraction (grade ≥3, n=2) and 1 patient experienced LV dysfunction (grade 1). In the TPC arm, 1 patient experienced decreased ejection fraction (grade 1), and 2 patients experienced cardiac failure (grade ≥3, n=1).1

Abbreviations

DCO = data cut-off

;

ILD = interstitial lung disease

;

LV = left ventricular

;

T-DXd = trastuzumab deruxtecan

;

TEAE = treatment emergent adverse event

;

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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