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Izalontamab brengitecan is the first bispecific ADC to succeed in a phase 3 trial, hitting two growth receptors at once in triple-negative breast cancer.
EGFR×HER3 bispecific ADC from SystImmune (Sichuan Biokin), partnered with Bristol Myers Squibb (2023, up to $8.4B). Phase 3 BL-B01D1-307 in previously treated locally advanced/metastatic TNBC met PFS and OS at interim analysis (announced 26 February 2026; presented ASCO 2026). Also positive in oesophageal squamous cell carcinoma. IZABRIGHT-Breast01 (first-line TNBC, PD-1 ineligible) and trials in NSCLC (EGFR-mutant, post-TKI), urothelial, nasopharyngeal, and SCLC are ongoing. Haematologic toxicity is the main limitation.
Iza-bren (Ed-04) carries a camptothecin-derived TOP1 inhibitor; exatecan shown as the class representative.
Dual EGFR/HER3 binding drives internalisation across heterogeneous tumours; TOP1 payload with bystander effect. Connects to EGFR and HER3.
1.Antibody binds EGFR and HER3 (bispecific) on the tumour cell surface
Source: clinicaltrials.gov/study/NCT06382142. Doses are for orientation; the current label governs.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2023-12-11 | SystImmune / Sichuan Biokin to Bristol Myers Squibb Izalontamab brengitecan (BL-B01D1), EGFR x HER3 bispecific ADC | Licence | $800m | up to $8.4bn | source |
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| Adverse event |
|---|
| Neutropenia |
| Anaemia |
| Thrombocytopenia |
| Stomatitis |
| Nausea |
Haematologic toxicity is the main limitation in phase 1-3 reports; rates per ASCO 2026 presentation. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Investigational; BMS filing expected after BL-B01D1-307 | not disclosed | - |
| China | NMPA filings under review (2026) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Izalontamab brengitecan" OR ABSTRACT:"Izalontamab brengitecan" OR TITLE:"iza-bren" OR ABSTRACT:"iza-bren" OR TITLE:"BL-B01D1" OR ABSTRACT:"BL-B01D1") 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 Izalontamab brengitecan, not a curated reading list.
Shares Exatecan (and derivatives), Topoisomerase-I inhibitor payloads, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs, Bispecific ADC.
Shares Exatecan (and derivatives), Topoisomerase-I inhibitor payloads, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs, Bispecific ADC.
Shares EGFR TKI → ADC on progression, Topoisomerase-I inhibitor payloads, HER3, Metastatic triple-negative breast cancer.
Shares Exatecan (and derivatives), Topoisomerase-I inhibitor payloads, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares EGFR TKI → ADC on progression, Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer, Topoisomerase-I inhibitor payloads, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs.
Shares A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma(PANKU-NPC01), A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and , A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other, EGFR.
Shares A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung , A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, EGFR TKI → ADC on progression, A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metas.
Shares Exatecan (and derivatives), Topoisomerase-I inhibitor payloads, Antibody-drug conjugate (ADC), Triple-negative breast cancer (TNBC).