DESTINY-Breast06: Safety Results (March 18, 2024 DCO Date)
Overall Safety Summary1
- The median treatment duration was 11.0 months (range 0.4–39.6) for T-DXd and 5.6 months (range 0.1–35.9) for TPC.
- Most common TEAE associated with treatment discontinuation was pneumonitisa (5.3%) for T-DXd and peripheral sensory neuropathy (1.4%) for TPC.
- Most common TEAE associated with dose reduction was nausea (4.4%) for T-DXd and PPE (16.5%) for TPC.
aIn the T-DXd group, 3.5% of patients discontinued due to interstitial lung disease
Overall Safety Summary1
Overall Safety Summary1
*Safety analyses included all patients who received at least one dose of study treatment.
‡Reasons were interstitial lung disease (n=2), sepsis (n=1), neutropenic sepsis (n=1) and general physical health deterioration (n=1).
Drug-Related TEAEs in ≥20% of Patients1
Most Common Drug-Related TEAEs (≥20% of Patients) 1
Most Common Drug-Related TEAEs (≥20% of Patients) 1
aIncludes the preferred terms fatigue, asthenia, malaise, and lethargy.
bIncludes the preferred terms neutrophil count decreased and neutropenia.
cIncludes the preferred terms transaminases increased, aspartate aminotransferase increased, alanine aminotransferase increased, gamma-glutamyl transferase increased, liver function test abnormal, hepatic function abnormal, and liver function test increased.
dIncludes the preferred terms hemoglobin decreased, red blood cell count decreased, anemia, and hematocrit decreased.
eIncludes the preferred terms white blood cell count decreased and leukopenia.
Adverse Events of Special Interest1
Adverse Events of Special Interest 1
Adverse Events of Special Interest 1
*Grouped term. Median time to first onset of interstitial lung disease / pneumonitis for patients with T-DXd was 141 days (range 37–835). No pending cases of drug-related interstitial lung disease/pneumonitis to be adjudicated. One interstitial lung disease–related death per investigator assessment was upheld by the adjudication committee. An additional two deaths were adjudicated as interstitial lung disease–related by the adjudication committee.
†Data for the most common preferred terms are shown on the slide; additionally, one patient in each treatment group had the preferred term left ventricular dysfunction (Grade 3 with T-DXd, Grade 2 with TPC).
Abbreviations
DCO = data cut-off
;ILD = interstitial lung disease
;PPE = palmar-plantar erythrodysesthesia syndrome
;T-DXd = trastuzumab deruxtecan
;TEAE = treatment emergent adverse event
;TPC = treatment of physician's choice
References
1. Curigliano G, Hu X, Dent R, et al. Trastuzumab deruxtecan vs physician’s choice of chemotherapy in patients with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–low or HER2-ultralow metastatic breast cancer with prior endocrine therapy: primary results from DESTINY-Breast06. Presented at 2024 ASCO Annual Meeting; May 31-June 4, 2024; Chicago, Illinois. Presentation LBA1000.
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Document ID: c791d159-0a5c-4180-b38f-cd5e26050804
Last updated: 28-June-2024
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