Confirmed Objective Response Rate (ORR)

In 184 patients who progressed on 2L anti-HER2 therapy for unresectable or mBC,

ENHERTU monotherapy delivered a remarkable response with 60.3% 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)
Response rates of 58%-67% were observed 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 with an encore at Miami Breast 2021

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2L, second line; CI, confidence interval; CR, complete response; 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; mBC, metastatic breast cancer; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.