Annals of oncology : official journal of the European Society for Medical Oncology · 2026
Safety and antitumor activity of the first-in-class EGFR-HER3 bispecific antibody-drug conjugate iza-bren (BL-B01D1) in patients with pretreated locally advanced or metastatic breast cancer: a phase 1b study.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Zhang J, Meng Y, Du Y, Sun T, Cui J, Chen Y, Sun Y, Wang Y, Chen W, Xu F, Shi Y, Chen Y, Wang K, Jin G, Zhou H, Zhuang Z, Xie W, Wang Z, Sun M, Wen Q, Wang X, Wang C, Xiao S, Zhu H, Zhu Y, Wu J
Аннотация
BACKGROUND: Bispecific antibody-drug conjugates (ADCs) may overcome limitations of monospecific ADCs. We report results from a phase 1b study of iza-bren, a first-in-class EGFR-HER3 bispecific ADC, in patients with heavily pretreated locally advanced or metastatic breast cancer.
PATIENTS AND METHODS: This multicenter study enrolled pretreated patients into three groups: HER2-positive (n=41), hormone receptor-positive/HER2-negative (HR+/HER2-; n=75), and triple-negative breast cancer (TNBC; n=46). Patients received iza-bren 2.5 mg/kg intravenously on days 1 and 8 of each 21-day cycle. The primary endpoint was safety.
RESULTS: All 162 enrolled patients were heavily pretreated (69.8% had ≥3 prior lines of therapy). Treatment-related adverse events (TRAEs) occurred in 99.4% of patients, with grade ≥3 events observed in 77.8%, primarily hematologic toxicities (neutropenia 55.6%, anemia 42.0%). Two treatment-related deaths occurred (febrile neutropenia and intracranial hemorrhage). No interstitial lung disease was reported. Confirmed objective response rates were 46.3% (95% confidence interval [CI], 30.7-62.6) in HER2-positive, 37.3% (95% CI, 26.4-49.3) in HR+/HER2-, and 34.8% (95% CI, 21.4-50.2) in TNBC groups, with median progression-free survival of 5.8, 7.0, and 5.8 months, respectively.
CONCLUSIONS: Iza-bren exhibited a generally tolerable safety profile and demonstrated clinically meaningful antitumor activity across three major subtypes of heavily pretreated metastatic breast cancer.
PATIENTS AND METHODS: This multicenter study enrolled pretreated patients into three groups: HER2-positive (n=41), hormone receptor-positive/HER2-negative (HR+/HER2-; n=75), and triple-negative breast cancer (TNBC; n=46). Patients received iza-bren 2.5 mg/kg intravenously on days 1 and 8 of each 21-day cycle. The primary endpoint was safety.
RESULTS: All 162 enrolled patients were heavily pretreated (69.8% had ≥3 prior lines of therapy). Treatment-related adverse events (TRAEs) occurred in 99.4% of patients, with grade ≥3 events observed in 77.8%, primarily hematologic toxicities (neutropenia 55.6%, anemia 42.0%). Two treatment-related deaths occurred (febrile neutropenia and intracranial hemorrhage). No interstitial lung disease was reported. Confirmed objective response rates were 46.3% (95% confidence interval [CI], 30.7-62.6) in HER2-positive, 37.3% (95% CI, 26.4-49.3) in HR+/HER2-, and 34.8% (95% CI, 21.4-50.2) in TNBC groups, with median progression-free survival of 5.8, 7.0, and 5.8 months, respectively.
CONCLUSIONS: Iza-bren exhibited a generally tolerable safety profile and demonstrated clinically meaningful antitumor activity across three major subtypes of heavily pretreated metastatic breast cancer.