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SystImmune's HER2 ADC, sharing its payload with iza-bren, now in a 1,450-patient trial to replace Kadcyla after surgery.
Trastuzumab brengitecan is SystImmune's HER2 antibody-drug conjugate: an anti-HER2 antibody joined through a cleavable linker to the payload Ed-04, which can cross into neighbouring cells (bystander effect) and is shared with the company's iza-bren. Phase 1 data (ESMO 2025; Lancet-family 2026) showed responses in both HER2-positive and HER2-low breast cancer. A phase 3 trial of about 1,450 patients is enrolling in China, comparing it with T-DM1 in patients with residual disease after neoadjuvant therapy (NCT06830889). That is the same setting DESTINY-Breast05 has just redefined with T-DXd (3-year invasive disease-free survival 92.4% versus 83.7%, HR 0.47), so the trial's relevance depends on whether T-DM1 remains a fair comparator. For a newcomer, it is a Chinese HER2 ADC trying to replace Kadcyla after surgery.
Trastuzumab brengitecan (BL-M07D1) carries a camptothecin-derived TOP1 inhibitor; exatecan shown as the class representative.
Anti-HER2 antibody with cleavable linker and Ed-04 payload (bystander-capable). Connects to HER2.
1.Trastuzumab brengitecan's antibody arm binds HER2 on the surface of the cancer cell.
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Phase 3 vs T-DM1 in residual disease registered (NCT06830889) source
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Query for this drug: (TITLE:"Trastuzumab brengitecan" OR ABSTRACT:"Trastuzumab brengitecan" OR TITLE:"BL-M07D1" OR ABSTRACT:"BL-M07D1" OR TITLE:"T-Bren" OR ABSTRACT:"T-Bren") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trastuzumab brengitecan, not a curated reading list.
Shares A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer, A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy, DESTINY-Breast05, HER2.
Shares A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NS, A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer, A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC, Topoisomerase-I inhibitors (and ADC payloads).
Shares SystImmune / Sichuan Biokin, HER2-positive breast cancer.
Shares A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy, A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Brea, DESTINY-Breast05, HER2-positive breast cancer.
Shares SystImmune / Sichuan Biokin, HER2-positive breast cancer.
Shares SystImmune / Sichuan Biokin, Topoisomerase-I inhibitors (and ADC payloads).
Shares SystImmune / Sichuan Biokin, Antibody-drug conjugate (ADC).
Shares SystImmune / Sichuan Biokin, Antibody-drug conjugate (ADC).