DESTINY-Breast03 Phase 3 Study Results slide image

DESTINY-Breast03 Phase 3 Study Results

Background 10 Daiichi-Sankyo DESTINY-Breast03 Progression-Free Survival Probability, % 100 PFS by BICR¹‚ª mPFS (95% CI), mo 12-mo PFS rate (95% CI), % T-DXd NR (18.5-NE) 75.8 (69.8-80.7) HR (95% CI) 80 60 40 2 + Censor T-DXd (n = 261) 0 T-DM1 (n = 263) 0 1 2 3 4 5 6 7 8 Patients Still at Risk: T-DM1 6.8 (5.6-8.2) 34.1 (27.7-40.5) 0.28 (0.22-0.37) P= 7.8 X 10-22 HHHHH 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Time, months T-DXD (261) 261 256 250 244 240 224 214 202 200 183 168 164 150 132 112 105 79 84 53 45 38 29 25 19 T-DM1 (263) 263 252 200 163 155 132 108 98 93 78 65 60 51 43 37 34 29 23 21 16 12 8 8 4 1 1 1 10 8 5 3 2 0 1 1 1 1 1 0 T-DXd, a HER2-targeted ADC, was approved for the treatment of patients with HER2+ unresectable or mBC who have received a prior anti-HER2 therapy in the metastatic or neoadjuvant/adjuvant setting and had recurrence during or within 6 months after therapy² DESTINY-Breast03 (NCT03529110) investigated T-DXd vs T-DM1 in patients with HER2+ unresectable or mBC ■ In the primary analysis (May 21, 2021), T-DXd was superior to T-DM1 for PFS by BICR (primary endpoint)1 ■ Overall health status and QoL was maintained with T-DXd and numerically favored T-DXd over T-DM13 ADC, antibody-drug conjugate; BICR, blinded independent central review; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; mBC, metastatic breast cancer; mPFS, median progression-free survival; PFS, progression-free survival; QoL, quality of life; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan. 1. Cortés J et al. N Engl J Med. 2022;386:1143-1154. 2. Enhertu (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use. Daiichi Sankyo, Inc; 2022. 3. Curigliano G et al. Presented at ESMO Breast Cancer meeting; May 3-5, 2022; Berlin, Germany. Presentation 1630. From New England Journal of Medicine, Cortés J et al, Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer, Vol. 386, Pages 1143-1154. Copyright ©2022 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. ASCO 2022 #1000 Oral 24 24
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