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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

Business Wire•23/10/2026•07:30 ET
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Key Highlights

  • ➤Iza-bren cut progression or death risk 59% versus chemotherapy
  • ➤Median PFS reached 8.2 months versus 4.0 months with chemotherapy
  • ➤Confirmed response rate was 40.5% versus 20.2% with chemotherapy
  • ➤Iza-bren discontinuation due to treatment-related adverse events was 1.6%
  • ➤Bristol Myers Squibb and SystImmune are jointly developing iza-bren outside China

Expert Statements

Binghe Xu, Professor and Academician of the Chinese Academy of Engineering, Cancer Hospital Chinese Academy of Medical Sciences

“While there have been advances in the treatment landscape for HR-positive, HER2-negative advanced breast cancer, options can become increasingly limited as patients progress through available therapies, with most ultimately relying on chemotherapy”

Binghe Xu, Professor and Academician of the Chinese Academy of Engineering, Cancer Hospital Chinese Academy of Medical Sciences

“PANKU-Breast01 provides encouraging evidence for a new therapeutic approach.”

Binghe Xu, Professor and Academician of the Chinese Academy of Engineering, Cancer Hospital Chinese Academy of Medical Sciences

“Unlike other ADCs, izalontamab brengitecan is designed to target both EGFR and HER3, and the reduction in the risk of disease progression or death suggests it could offer patients a meaningful new treatment option.”

Jonathan Cheng, Chief Medical Officer of SystImmune

“The 59% reduction in progression or death we see with iza-bren represents a substantial advance for patients who have limited treatment options after prior chemotherapy”

Jonathan Cheng, Chief Medical Officer of SystImmune

“This Phase 3 data, combined with our positive results in triple-negative breast cancer, demonstrates that our dual EGFRxHER3-targeting approach can meaningfully address the biology of multiple breast cancer subtypes and represents an important step towards more effective, precision-based treatment strategies.”

Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development, Bristol Myers Squibb

“The positive PANKU-Breast01 results are an important validation of iza-bren’s potential as an innovative scientific approach to overcome disease resistance and the limitations of currently available treatment options”

Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development, Bristol Myers Squibb

“Together with the clinical benefit iza-bren has shown in other tumor types, these data position iza-bren as a potentially first-in-class dual-targeting ADC therapy with the potential to become a new standard of care across the cancer treatment paradigm.”

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

Late-breaking results to be presented in an oral presentation at ESMO 2026

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