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

Safety Overview

Safety Overview11. 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.

  • The most common any-grade AEs were nausea and vomiting
  • Grade 3 nausea and vomiting were reported in 3 patients (8.6%) and 1 patient (2.9%), respectively (no Grade 4 or Grade 5 vomiting events were reported)
  • The most common Grade ≥3 AEs were neutropenia (20.0%),* nausea (8.6%), fatigue (5.7%), and lymphopenia (5.7%)
  • Adjudicated drug-related interstitial lung disease/pneumonitis was reported in 3 patients (8.6%)

*Grouped term including neutropenia and decreased neutrophil count events

Safety Overview11. 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.


n (%)

Module 7

T-DXd in patients with active BMs

(N=35)

Any-grade AEs35 (100.0)

Any-grade AE by preferred term (>30% of patients)

   Nausea

   Vomiting

   Anemia

   Constipation

   Neutropenia

   Decreased appetite

   Fatigue


26 (74.3)

16 (45.7)

13 (37.1)

13 (37.1)

13 (37.1)

11 (31.4)

11 (31.4)

AE Grade ≥318 (51.4)
AE associated with T-DXd interruption16 (45.7)
AE associated with T-DXd dose reduction8 (22.9)
AE associated with T-DXd discontinuation2 (5.7)a
Any SAE5 (14.3)
AE leading to death2 (5.7)b

AESI

   Left ventricular dysfunction

   Pneumonitis (adjudicated as ILD related to T-DXd)

      Grade 2

      Grade 5


0

3 (8.6)

2 (5.7)

1 (2.9)c

aBoth AEs were reported as adjudicated ILD/pneumonitis; bCerebral hemorrhage reported by investigator as not related to T-DXd, n=1; pneumonitis adjudicated as ILD related to T-DXd, n=1; cPatient presented with symptoms of dyspnea, dry cough, and coryza on Day 66 of study treatment and was admitted to hospital four days later; HRCT was performed, GGO and reticular opacities were found. Patient had no evidence of infection or cancer progression within the thorax. Radiotherapy was previously administered to the chest. Patient was administered 1g of methyl prednisolone and antibiotics, but experienced clinical worsening.

Abbreviations

AE = adverse event

;

AESI = adverse event of special interest

;

BM = brain metastases

;

DCO = data cutoff

;

GGO = ground-glass opacity

;

HRCT = high-resolution computed tomography

;

ILD = interstitial lung disease

;

SAE = serious adverse event

;

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

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