DESTINY-Breast03 Phase 3 Study Results
Daiichi-Sankyo
Conclusions
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T-DXd 5.4 mg/kg IV Q3W in combination with nivolumab 360 mg Q3W showed antitumor
activity consistent with previously reported data for T-DXd monotherapy in patients with
HER2-positive BC
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The addition of nivolumab to T-DXd in the late-line setting, however, showed no discernible
benefit
The data from the small HER2-low BC cohort are insufficient to determine the effects of anti-
PD-1/PD-L1 therapy combined with T-DXd in the late-line setting
The overall safety profile was generally consistent with previous studies for T-DXd
monotherapy in patients with BC, and the addition of nivolumab did not appear to cause
any overall increased toxicity
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The incidence of adjudicated ILD/pneumonitis across both cohorts was 14.6%
All but 1 ILD/pneumonitis events were low grade (grade 2)
An exploratory biomarker analysis showed that patients with HER2-positive and HER2-
low BC responded to treatment with T-DXd plus nivolumab regardless of PD-L1 IHC
status
However, results should be interpreted with caution given the small sample size
BC, breast cancer; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ILD, interstitial lung disease; IV, intravenous; ORR, objective response rate; PD-1, PD-L1, programmed death 1;
PD-L1, programmed death ligand 1; Q3W, every 3 weeks; TC, tumor cell; T-DXd, trastuzumab deruxtecan.
ESMO BC 2022 #1620 Oral
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