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Izalontamab Brengitecan (Iza-Bren) Reduced Risk of Disease Progression or Death by 59% versus Chemotherapy in Patients with Advanced HR+/HER2- Breast Cancer in Phase 3 PANKU-Breast01 Study

BMY
  • SystImmune's parent company Biokin reported positive interim results from the Phase 3 PANKU-Breast01 study for izalontamab brengitecan (iza-bren) in HR+/HER2- metastatic breast cancer.
  • Iza-bren reduced the risk of disease progression or death by 59% compared to chemotherapy, with a median progression-free survival of 8.2 months versus 4.0 months.
  • The confirmed objective response rate was 40.5% for iza-bren versus 20.2% for chemotherapy, with a median duration of response of 6.9 months versus 4.2 months.
  • Results will be presented as a late-breaking oral session at ESMO 2026 in Madrid & simultaneously published in The Lancet.
  • The safety profile was manageable, with Grade ≥3 treatment-related adverse events primarily being hematologic & only 1.6% of patients discontinuing due to adverse events.
  • Iza-bren has demonstrated clinical benefit in five Phase 3 trials across five distinct tumor types, including breast cancer, NSCLC, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, & triple-negative breast cancer.
  • Iza-bren received Breakthrough Therapy Designation from the U.S. FDA for previously-treated advanced EGFR-mutated NSCLC.
  • The drug is a dual-targeting EGFRxHER3 bispecific antibody-drug conjugate developed jointly by SystImmune & Bristol Myers Squibb outside of China.
  • The PANKU-Breast01 study was sponsored by Biokin in Mainland China, while outside China the asset is under a collaboration agreement between SystImmune & Bristol Myers Squibb.