Izalontamab brengitecan extended median progression-free survival to 11.1 months vs 5.7 months with chemotherapy after EGFR TKI failure.
SystImmune and Bristol Myers Squibb (BMS) announced on October 26, 2026, that izalontamab brengitecan (iza-bren) significantly improved progression-free survival (PFS) compared with platinum-based chemotherapy (PBC) in the
The trial enrolled patients with previously treated EGFR-mutated non-squamous non-small cell lung cancer (NSCLC). The results come from a prespecified interim analysis reported by SystImmune's parent company, Sichuan Biokin Pharmaceutical (Biokin). They were set for a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) 2026 Annual Congress in Madrid, Spain, with simultaneous publication in The Lancet, according to the companies.¹
"When EGFR-mutated NSCLC progresses after an EGFR TKI [tyrosine kinase inhibitor] therapy, patients and physicians have historically had few effective treatment options, with chemotherapy often serving as the default, though it offers limited survival benefit," said Li Zhang, chief lung cancer expert at Sun Yat-sen University Cancer Center, in a company press release.¹
The randomized, multicenter trial (NCT06382116) enrolled patients whose disease progressed after EGFR tyrosine kinase inhibitor (TKI) therapy. The registry record specifies progression during or after a third-generation EGFR TKI.¹,² At a median PFS follow-up of 14.6 months, median PFS by blinded independent central review (BICR) was 11.1 months with iza-bren (n=216) vs 5.7 months with PBC (n=206) (hazard ratio [HR], 0.40; 95% confidence interval [CI], 0.31-0.51; p<.0001).¹
The confirmed objective response rate by BICR was 60.2% with iza-bren vs 34.5% with PBC, and median duration of response was 10.4 months vs 5.7 months.¹ Overall survival, a secondary endpoint, was immature, although the companies reported a favorable trend toward improved survival with iza-bren.¹
No new safety signals were observed, according to the companies.¹ Grade 3 or higher treatment-related adverse events (TRAEs) were predominantly hematologic and were managed with standard supportive care. Only 1.9% of patients in the iza-bren group discontinued treatment due to TRAEs.¹ Adjudicated interstitial lung disease occurred in 2 patients (0.9%), 1 grade 3 and 1 grade 1.¹
According to the companies, iza-bren has now shown clinical benefit in 5 phase 3 trials across these 5 indications:¹
FDA has granted the ADC breakthrough therapy designation for previously treated advanced EGFR-mutated NSCLC.¹ Biokin sponsors PANKU-Lung01 in mainland China. Outside China, SystImmune and BMS develop iza-bren jointly under a collaboration and exclusive license agreement.¹
The findings come from a prespecified interim analysis, and overall survival data remain immature, so a survival benefit has not been established. The trial was conducted in mainland China, which may limit how well the results apply to other populations. Detailed results were not independently reviewed before this report. Iza-bren is not approved by FDA for any indication, and breakthrough therapy designation does not guarantee approval.
In separate news, BMS disclosed a patient death in its phase 1 Breakfree-2 study of
