Confirmed Objective Response Rate (ORR)

In 184 female patients with HER2+ unresectable or mBC,

ENHERTU monotherapy demonstrated a 60.3% confirmed ORR1,a

Bar chart depicting that ENHERTU monotherapy demonstrated a 60.3% confirmed objective response rate (n=111 of 184 patients, 95% CI: 52.9, 67.4); with 4.3% achieving complete response (n=8) and 56% achieving partial response (n=103) Bar chart depicting that ENHERTU monotherapy demonstrated a 60.3% confirmed objective response rate (n=111 of 184 patients, 95% CI: 52.9, 67.4); with 4.3% achieving complete response (n=8) and 56% achieving partial response (n=103)
ENHERTU anti-tumor activity assessed in these select prespecified exploratory patient subgroups2,a,b
Presence of visceral metastases
With visceral
metastases

60% ORR
(n=102/169; 95% CI:
53, 68)
Without visceral
metastases

67% ORR
(n=10/15; 95% CI:
38, 88)
Presence of brain metastasesc
With stable
brain metastases

58% ORR
(n=14/24; 95% CI:
37, 78)
Without brain
metastases

61% ORR
(n=98/160; 95% CI:
53, 69)
HR status
HR+
58% ORR
(n=56/97; 95% CI:
47, 68)
HR-
66% ORR
(n=55/83; 95% CI:
55, 76)

aORR defined as CR+PR per RECIST v1.1 in the ITT population as evaluated by ICR.1,2 bData based on cutoff date of August 1, 2019.2 cPatients with inactive (asymptomatic and previously treated) brain metastases. Brain lesions were non-target lesions.2

DESTINY-Breast01
follow-up data

(June 2020 data cutoff)
Originally presented at SABCS 2020

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CBR, clinical benefit rate; CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; FDA, Food and Drug Administration; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; HR-, hormone receptor negative; HR+, hormone receptor positive; ICR, independent central review; ITT, intent-to-treat; IV, intravenous; mBC, metastatic breast cancer; mDOR, median duration of response; mPFS, median progression-free survival; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.