DESTINY-Breast03 Phase 3 Study Results
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Daiichi-Sankyo
Conclusions
DESTINY-Breast03
No new safety signals were observed for T-DXd in patients with HER2+ mBC in this
safety update, 1-3 and in-depth analysis demonstrated that:
■ Most TEAEs were grade 1 or 2, and exposure-adjusted incidence rates of grade ≥3 TEAEs
and serious TEAEs were lower with T-DXd than T-DM1
Risk of nausea, vomiting, fatigue, and alopecia was higher for T-DXd in the initial treatment
cycles
■ Prevalence of nausea and vomiting was higher for T-DXd in the initial treatment cycles and
was consistent over time for alopecia and fatigue
o In the T-DXd arm, the increased risk and higher prevalence of these events that persisted
throughout treatment duration necessitates ongoing supportive care
■ There were no additional grade 3 adjudicated ILD/pneumonitis events with T-DXd (overall rate
= 0.8%), and no grade 4 or 5 events overall
These data reinforce the established favorable benefit/risk profile of
T-DXd over T-DM1 in HER2+ mBC
HER2, human epidermal growth factor receptor-2; ILD, interstitial lung disease; mBC, metastatic breast cancer; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; TEAE, treatment-emergent adverse event.
1. Modi S et al. J Clin Oncol. 2020;38:1887-1896. 2. Modi S et al. N Engl J Med. 2020;382:610-621. 3. Cortés J et al. N Engl J Med. 2022;386:1143-1154.
Safety update: Sept 7, 2021
ASCO 2022 #1000 Oral
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