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Efficacy Outcomes 

Systemic Efficacy of T-DXd 5.4 mg/kg1

Efficacy Outcomes in BM, Non-BM Subgroups and Overall Population.1 
 

BM Subgroup

(n=24)

Non-BM Subgroup

(n=160)

All Patients

(N=184)

Confirmed ORR
(CR + PR) by ICR, n (%)a

14 (58.3)

95% CI, 36.6-77.9

98 (61.3)

95% CI, 53.2-68.8

112 (60.9)

95% CI, 53.4-68.0

CR1 (4.2)10 (6.3)11 (6.0)
PR13 (54.2)88 (55.0)101 (54.9)
SD8 (33.3)59 (36.9)67 (36.4)
PD1 (4.2)2 (1.3)2 (1.1)
Not evaluable1 (4.2)1 (0.6)3 (1.6)
BOR in the brain
(CR + PR), n (%)b		8 (47.1)––
Median DOR (CR or PR), months,
(95% CI)

16.9

(5.7-16.9)

14.8

(13.8-NE)

14.8

(13.8-16.9)

Median PFS, months, (95% CI)

18.1

(6.7-18.1)

16.4

(12.7-NE)

16.4

(12.7-NE)

aData are for all randomly assigned patients who received ≥1 dose of T-DXd 5.4 mg/kg and had measurable tumors based on ICR at baseline (N=184); bBy investigator assessment. Percentage expressed out of number of patients with baseline BM measurements as provided by the investigator (n=17).

Best Change in Tumor Size

Best Change in Tumor Size1

Best Percent Change From Baseline in Sum of the Longest Diameters of Measurable Tumors By ICR.1,a

Best Percent Change From Baseline in Sum of the Longest Diameters of Measurable Tumors By ICR.1,a

aIncludes patients who had both baseline and postbaseline target lesion assessments by ICR. The line at 20% indicates PD; the line at −30% indicates PR. A total of 168 patients from the enrolled analysis set of 184 patients, for whom data from both baseline and postbaseline assessments of target lesions by ICR were available.

Progression-Free Survival

Progression-Free Survival1

Progression-Free Survival.1

Progression-Free Survival.1

The tick marks in each panel indicate patient data that were censored

Central Nervous System Response

Central Nervous System Response1

  • In the BM subgroup, 17/24 patients had brain lesions at baseline; data were available to evaluate responses in the brain for 15 patients1
    • 7/17 (41.2%) had a reduction in brain lesion diameters consistent with a best response of PR in the brain based on the investigator's assessment

Best Response in Brain Lesions in the BM Subgroup.1

Best Response in Brain Lesions in the BM Subgroup.1

Brain Lesion Measurements Over Time in Patients in the BM Subgroup.1

Brain Lesion Measurements Over Time in Patients in the BM Subgroup.1

Sites of Progression

Sites of Progression1

  • Sites of progression were similar among all patients and the BM subgroup1
  • Only 2.2% (4 of 184) had BM progression, including 2 patients who had BM disease at baseline1
  • BM progression events:1
    • At 75 and 85 days in the baseline BM subgroup
    • At 323 and 498 days in patients without a history of BM metastases
Sites of Progression.1
Site of PDCNS Subgroup
(n=24)		Non-CNS Patients (n=160) All Patients
(N=184)
Patients with progression on study, n (%)8 (33.3)40 (25.0)48 (26.1)
Lung3 (12.5)17 (10.6)20 (10.9)
Liver2 (8.3)12 (7.5)14 (7.6)
Brain2 (8.3)2 (1.3)4 (2.2)
Bone1 (4.2)2 (1.3)3 (1.6)
Lymph node1 (4.2)11 (6.9)12 (6.5)
Pleura1 (4.2)1 (0.6)2 (1.1)
Soft tissue1 (4.2)01 (0.5)
Chest wall04 (2.5)4 (2.2)
Muscle01 (0.6)1 (0.5)
Peritoneum01 (0.6)1 (0.5)

For patients in the CNS subgroup, a CT or MRI of the brain was mandatory every 6 wks (±7 days).


Abbreviations

BM = brain metastases

;

BOR = best overall response

;

CR = complete response

;

CT = computed tomography

;

DCO = data cut-off

;

DOR = duration of response

;

HR = hormone receptor

;

ICR = independent central review

;

mo = months

;

mPFS = median progression-free survival

;

MRI = magnetic resonance imaging

;

NE = not evaluable

;

ORR = objective response rate

;

PD = progressive disease

;

PFS = progression-free survival 

;

PR = partial response 

;

SD = stable disease

;

T-DXd = trastuzumab deruxtecan

References

1. Jerusalem G, Park Y, Yamashita S, et al. Trastuzumab deruxtecan in HER2-positive metastatic breast cancer patients with brain metastases: A DESTINY-Breast01 subgroup analysis [article and supplementary appendix]. Cancer Discov. 2022;12(12):2754-2762

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