HER2 ultra-low Metastatic Breast Cancer Patients
(March 2024)
Most common drug-related adverse events (in ≥20% of patients in either treatment arm)
in the safety analysis set
- The overall rate of Grade ≥3 drug-related adverse reactions was 40.6% with
ENHERTU and 31.4% with chemotherapy2 - Median duration of treatment was
11 months (range: 0.4-39.6) with ENHERTU and 5.6 months (range: 0.1-35.9) with chemotherapy2
with earlier use of ENHERTU in patients with HR+/HER2-low or HR+/HER2-ultralow mBC1
aIncludes fatigue, asthenia, malaise, and lethargy. bIncludes neutrophil count decreased and neutropenia. cIncludes transaminases increased, aspartate aminotransferase increased, alanine aminotransferase increased, gammaglutamyltransferase increased, liver function test abnormal, hepatic function abnormal, and liver function test increased. dIncludes hemoglobin decreased, red blood cell count decreased, anemia, and hematocrit decreased. eIncludes white blood cell count decreased and leukopenia.
a favorable benefit-risk profile with ENHERTU that was
consistent with prior studies in HER2-expressing mBC2-5,a
(March 2024)
- There were 5 (1.2%) patients who received ENHERTU with drug-related (investigator-assessed) adverse reactions leading to death; 2 attributed
to ILD and 1 each to sepsis, neutropenic sepsis, and general physical health deterioration2
11 months (range: 0.4-39.6) with
ENHERTU and 5.6 months (range: 0.1-35.9) with chemotherapy2
aPrior ENHERTU HER2-expressing mBC studies: Phase 3 DESTINY-Breast04, Phase 3 DESTINY-Breast03, Phase 2 DESTINY-Breast01, and Phase 1 DS8201-A-J101.6
Grade 5 cases, were reported with
ENHERTU in DESTINY-Breast06; the majority were Grade 1 or 2 1,2,a
(March 2024)
Incidence of ILD/pneumonitis in
DESTINY-Breast06
- Of the 434 patients treated with ENHERTU 5.4 mg/kg, ILD occurred in 11.3% (n=49/434):1,2
– Three Grade 5 adjudicated drug-related ILD/pneumonitis events were observed with ENHERTU
– 87.8% of the ILD cases were Grade 1 or 2 (n=43/49) - In DESTINY-Breast06, median time to first onset of ILD/pneumonitis for patients treated with ENHERTU was 141 days (range: 37-835)1
aOne ILD-related death per investigator assessment was upheld by the adjudication committee. An additional 2 deaths were adjudicated as ILD related by the adjudication committee.2 bPrior ENHERTU HER2+ mBC studies: Phase 3 DESTINY-Breast03,
Phase 2 DESTINY-Breast01, and Phase 1 DS8201-A-J101.6
Abbreviations: HER2, human epidermal growth factor receptor 2; ILD, interstitial lung disease; mBC, metastatic breast cancer; TEAE, treatment-emergent adverse event.
References:
- Bardia A, et al. N Engl J Med.
2024;391(22):2110-2122. - Bardia A, et al. N Engl J Med.
2024;391(22):2110-2122; Supplement. - Modi S, et al. N Engl J Med. 2020;382(7):610-621.
- Modi S, et al. N Engl J Med. 2022;387(1):9-20.
- Cortés J, et al. N Engl J Med.
2022;386(12):1143-1154. - Enhertu Malaysia Prescribing Information.
