Iza-bren (izalontamab brengitecan; BL-B01D1) is a potential first-in-class EGFRxHER3 bispecific antibody-drug conjugate with a topoisomerase I payload. It is being developed for advanced epithelial cancers, including EGFR-mutated non-small cell lung cancer. The U.S. FDA granted Breakthrough Therapy Designation in 2025 based on ongoing clinical trial data.
Multiple phase 3 breast cancer trials reported significant findings in early 2026, including positive results for novel therapies across different subtypes. Key data includes progression-free survival benefits for palbociclib in HR-positive, HER2-positive advanced breast cancer and investigations of antibody-drug conjugates and combination therapies. Full trial findings are expected to be presented at upcoming medical meetings.
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
Baili Pharmaceutical Group Co., Ltd. is offering 8,634,300 H Shares on the Hong Kong Stock Exchange at HK$347.50 to HK$389.00 per share, with listing expected November 17, 2025. Bristol-Myers Squibb leads cornerstone investors with US$15 million commitment.
Bristol Myers Squibb and SystImmune reported that antibody-drug conjugate izalontamab brengitecan achieved statistically significant improvements in both progression-free and overall survival versus chemotherapy in a Phase III trial for triple-negative breast cancer.
Izalontamab brengitecan demonstrated statistically significant improvements in progression-free survival and overall survival compared to chemotherapy in patients with previously treated metastatic triple-negative breast cancer, marking the third Phase III success for the bispecific ADC.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07382726 |
Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial |
NOT_YET_RECRUITING | PHASE1 |
| NCT07106762 |
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy |
RECRUITING | PHASE2/PHASE3 |
| NCT07100080 |
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) |
RECRUITING | PHASE2/PHASE3 |
| NCT06926868 |
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) |
RECRUITING | PHASE2/PHASE3 |
