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
PANKU-Lung01 is the first Phase 3 trial to evaluate a dual-targeting EGFRxHER3 bispecific antibody-drug conjugate in this patient population
Iza-bren, a potentially first-in-class dual-targeting EGFRxHER3 bispecific antibody-drug conjugate, has now demonstrated clinical benefit in five distinct tumor types
BOTHELL, Wash. & PRINCETON, N.J., October 26, 2026--SystImmune, Inc. (SystImmune), a clinical stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today announced that SystImmune's parent company Sichuan Biokin Pharmaceutical, Ltd. (Biokin) reported positive results from a prespecified interim analysis in the randomized, multicenter Phase 3 PANKU-Lung01 (NCT06382116) study evaluating izalontamab brengitecan (iza-bren), an investigational, first-in-class, dual-targeting EGFRxHER3 bispecific antibody-drug conjugate (ADC), versus platinum-based chemotherapy (PBC) in patients with EGFR-mutated non-squamous non-small cell lung cancer (NSCLC) who were previously treated with an EGFR tyrosine kinase inhibitor (TKI). Results will be presented today in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) 2026 Annual Congress taking place October 23 – 27 in Madrid, Spain, and simultaneously published in The Lancet.
Median follow-up for progression-free survival (PFS) was 14.6 months. Results showed iza-bren (n=216) significantly improved PFS, the study's primary endpoint, compared to PBC (n=206), with a median PFS by Blinded Independent Central Review (BICR) of 11.1 months for iza-bren vs. 5.7 months for PBC (HR: 0.40; 95% CI: 0.31-0.51; p<0.0001). For the secondary endpoint of overall survival (OS), data were immature, though a favorable trend toward improved OS was observed with iza-bren vs. PBC. The confirmed objective response rate (cORR) by BICR was 60.2% for iza-bren vs. 34.5% for PBC, and the median duration of response (mDOR) was 10.4 months vs. 5.7 months.
"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," said Professor 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."