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DESTINY-Breast07: Conclusions (Results from Part 2/Module 7 [T-DXd in patients with active BMs] as of December 22, 2023 DCO) 

Conclusions

Conclusions11. Anders CP, Loi S, Hamilton E, et al. Safety, tolerability, and antitumor activity of T-DXd in patients with HER2-positive mBC and active brain metastases in DESTINY-Breast07. Poster 185P. Presented at European Society for Medical Oncology-Breast Cancer (ESMO-BC) Annual Meeting; May 15-17, 2024; Berlin, Germany.

  • T‑DXd demonstrates robust overall activity assessed by RECIST v1.1 per investigator; confirmed ORR was 80.0%, median DOR was 18.1 months, and median PFS was 19.5 months
  • T-DXd exhibits strong IC efficacy assessed by RANO‑BM per BICR; the confirmed IC ORR was 60.0%, median IC DOR was 14.2 months, and median IC PFS was 15.4 months
  • Safety and tolerability are consistent with the known profile of T‑DXd; no new safety signals have been observed and one Grade 5 adjudicated interstitial lung disease event has been reported

Data from larger cohorts of patients with brain metastases will provide further insights

(eg, DESTINY-Breast12 [NCT04739761])

Abbreviations

BICR = blinded independent central review

;

BM = brain metastases

;

DOR = duration of response

;

IC = intracranial

;

ORR = overall response rate

;

PFS = progression free survival

;

RANO-BM = Response Assessment Criteria for Neuro-Oncology Brain Metastases

;

RECIST v1.1 = Response Evaluation Criteria in Solid Tumors version 1.1

;

T-DXd = trastuzumab deruxtecan

References

1. Anders CP, Loi S, Hamilton E, et al. Safety, tolerability, and antitumor activity of T-DXd in patients with HER2-positive mBC and active brain metastases in DESTINY-Breast07. Poster 185P. Presented at European Society for Medical Oncology-Breast Cancer (ESMO-BC) Annual Meeting; May 15-17, 2024; Berlin, Germany.

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Document ID: 325e86bc-2a1f-401a-b8d6-fa304896a85b
Last updated: 14-February-2023