Izalontamab Brengitecan (Iza-Bren) Doubles Median Progression-Free Survival in Patients with Previously-Treated EGFR-Mutated Non-Small Cell Lung Cancer Compared to Chemotherapy in the Phase 3 PANKU-Lung01 Study
Key Highlights
- ➤Iza-bren median PFS 11.1 months versus 5.7 months for chemotherapy
- ➤Iza-bren PFS hazard ratio 0.40; p<0.0001 versus platinum-based chemotherapy
- ➤Iza-bren confirmed response rate 60.2% versus 34.5% for chemotherapy
- ➤Bristol Myers Squibb and SystImmune reported positive Phase 3 PANKU-Lung01 results
- ➤Iza-bren discontinuations due to treatment-related adverse events were 1.9%
Expert Statements
Li Zhang, Chief Lung Cancer Expert, Sun Yat-sen University Cancer Center
“When EGFR-mutated NSCLC progresses after an EGFR TKI therapy, patients and physicians have historically had few effective treatment options, with chemotherapy often serving as the default, though it offers limited survival benefit”
Li Zhang, Chief Lung Cancer Expert, Sun Yat-sen University Cancer Center
“The PANKU-Lung01 findings suggest that iza-bren could change the trajectory of the disease, offering patients more time before their disease worsens. These results could mark an important shift in how we approach acquired resistance in this disease to significantly improve patient outcomes.”
Jonathan Cheng, Chief Medical Officer, SystImmune
“Post-progression EGFR-mutated NSCLC represents one of oncology's challenging treatment scenarios. With iza-bren, we achieved a nearly two-fold improvement in median PFS, along with a well-understood safety profile and high response rate. This demonstrates that dual-targeting EGFR and HER3 may fundamentally shift outcomes for these patients.”
Jonathan Cheng, Chief Medical Officer, SystImmune
“These data validate our conviction that iza-bren addresses a critical unmet need and provides much-needed innovation for patients who often have limited options after TKI failure.”
Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development, Bristol Myers Squibb
“The PANKU-Lung01 results mark an important inflection point for iza-bren and reinforce our belief that this potentially first-in-class EGFRxHER3 bispecific ADC could, if approved, improve outcomes across the cancer treatment landscape.”
Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development, Bristol Myers Squibb
“The breadth of clinical benefit now seen across five tumor types is highly encouraging and speaks to the potential of iza-bren to address significant unmet needs in oncology. We are committed to advancing iza-bren with urgency to deliver this innovative treatment option to patients.”
Izalontamab Brengitecan (Iza-Bren) Doubles Median Progression-Free Survival in Patients with Previously-Treated EGFR-Mutated Non-Small Cell Lung Cancer Compared to Chemotherapy in the Phase 3 PANKU-Lung01 Study
Late-breaking results to be presented in an oral presentation at ESMO 2026
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