In DESTINY-Breast03, a head-to-head study vs T-DM1,
ENHERTU demonstrated superior PFS vs T-DM11
PRIMARY ENDPOINT (MAY 2021)
hazard ratio: 0.28
(95% Cl: 0.22, 0.37); P<0.0001
NR mPFS with ENHERTU (95% Cl: 18.5 months, NE)
vs 6.8 months with T-DM1 (95% Cl: 5.6, 8.2)1,2,a,b
- These data are from an exploratory PFS analysis conducted in July 2022, which was based on an open-label study and was not tested for statistical significance or powered to show a difference between treatment arms. Therefore, the clinical significance of these data is not known. Statistical significance of PFS was determined at the May 2021 analysis1-3
Progression-free survival3,c
aMedian duration of follow-up for PFS (BICR) at the May 2021 analysis: 16.2 months (range: 0-32.7) for ENHERTU and 15.3 months (range: 0-31.3) for T-DM1.2
bThe stratified log-rank test P value is compared with the allocated alpha of 0.0002 for this interim analysis (with 73% of the planned number of events for final analysis).1
cMedian duration of follow-up for PFS (BICR) at the July 2022 analysis: 28.4 months (IQR: 22.1-32.9) for ENHERTU and 26.5 months (IQR: 14.5-31.3) for T-DM1.3
In DESTINY-Breast03, a head-to-head study vs T-DM1,
ENHERTU demonstrated superior OS vs T-DM11
KEY SECONDARY ENDPOINT (JULY 2022)
HAZARD RATIO: 0.64
(95% Cl: 0.47, 0.87); P=0.0037
NR mOS with ENHERTU (95% Cl: 40.5 months, NE)
vs NR with T-DM1 (95% Cl: 34.0 months, NE)1,3,d
- These data are from an exploratory OS analysis conducted in November 2023, which was based on an open-label study and was not tested for statistical significance or powered to show a difference between treatment arms. Therefore, the clinical significance of these data is not known. Statistical significance of OS was determined at the July 2022 analysis1,3,4
Overall survival4,e
dThe stratified log-rank test P value is compared with the allocated alpha of 0.013 for this interim analysis (with 68% of the planned number of events for final analysis).1
eMedian duration of follow-up at the November 2023 analysis: 43 months (range: 0-62.9) for ENHERTU and 35.4 months (range: 0-60.9) for T-DM1.4
In DESTINY-Breast03, a head-to-head study vs T-DM1,
ENHERTU delivered 82.1% confirmed ORR5
- The DESTINY-Breast03 study protocol did not power ORR—a secondary endpoint—to detect treatment effect differences between arms. Therefore, the clinical significance of these data is not known
SECONDARY ENDPOINT (MAY 2021)
82.7% confirmed ORR with ENHERTU (n=205/248; 95% CI: 77.4, 87.2; 15.7% CR [n=39] + 66.9% PR [n=166]) and 36.1% with T-DM1 (n=87/241; 95% CI: 30.0, 42.5; 8.3% CR [n=20] + 27.8% PR [n=67])2,3,f
Confirmed objective response rate1,5,g
- ~98% of patients had disease control with ENHERTU (21.1% CR [n=52] + 61.0% PR [n=150] + 15.4% SD [n=38])
1 OUT OF EVERY 5 patients achieved a complete response with ENHERTU
fAnalysis was performed based on the patients with measurable disease assessed by BICR at baseline (n=248 patients randomized to receive ENHERTU; n=241 for T-DM1).2
gAnalysis was performed based on the patients with measurable disease assessed by BICR at baseline (n=246 patients randomized to receive ENHERTU; n=240 for T-DM1).5
In DESTINY-Breast03, a head-to-head study vs T-DM1,
The majority of patients had a tumor response with ENHERTU3
- The DESTINY-Breast03 study protocol did not power best percent change in the sum of the diameter of measurable tumors—an exploratory endpoint—to detect treatment effect differences between arms. Therefore, the clinical significance of these data is not known
Best percent change from baseline in the sum of diameters of measurable tumors
hOnly subjects with measurable disease at baseline and at least one postbaseline target lesion assessment are included.
In DESTINY-Breast03, a head-to-head study vs T-DM1,
Consistent PFS results were observed with ENHERTU in prespecified exploratory patient subgroups2
- The DESTINY-Breast03 study protocol did not power the prespecified exploratory patient subgroup analysis to detect treatment effect differences between subgroups. Therefore, the clinical significance of these data is not known
THE ONLY NCCN CATEGORY 1,
Preferred Option in 2L
HER2+ mBC6
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends fam-trastuzumab deruxtecan-nxki (ENHERTU) as the only Category 1, preferred 2L option for recurrent unresectable (local or regional) or stage IV HER2+ breast cancer6,i
NCCN Clinical Practice
Guidelines in Oncology
(NCCN
Guidelines®) Preferred
THE ONLY NCCN CATEGORY 1,
Preferred Option in 2L
HER2+ mBC6
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends fam-trastuzumab deruxtecan-nxki (ENHERTU) as the only Category 1, preferred 2L option for recurrent unresectable (local or regional) or stage IV HER2+ breast cancer6,i
iFam-trastuzumab deruxtecan-nxki may be considered in the first-line setting as an option for select patients (ie, those with rapid progression within 6 months of neoadjuvant or adjuvant therapy [12 months for pertuzumab-containing regimens]).6
2L, second line; BICR, blinded independent central review; CI, confidence interval; CR, complete response; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; HR-, hormone receptor negative; HR+, hormone receptor positive; IQR, interquartile range; mBC, metastatic breast cancer; mOS, median overall survival; mPFS, median progression-free survival; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not evaluable; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; SD, stable disease; T-DM1, ado-trastuzumab emtansine.