Key Highlights

  • Bristol Myers Squibb (NYSE:BMY) and SystImmune reported Phase 3 PANKU-Lung01 results for iza-bren in EGFR-mutated NSCLC.
  • Median progression-free survival was 11.1 months for iza-bren versus 5.7 months for platinum-based chemotherapy (HR 0.40).
  • The confirmed objective response rate was 60.2% versus 34.5%.
  • Overall survival data were immature, with a favorable trend reported.

Bristol Myers Squibb (NYSE:BMY) and SystImmune announced on 26 October 2026 positive results from a prespecified interim analysis of the Phase 3 PANKU-Lung01 study of izalontamab brengitecan (iza-bren) in previously treated EGFR-mutated non-squamous non-small cell lung cancer (NSCLC). The data were reported by SystImmune's parent company, Sichuan Biokin Pharmaceutical, and presented as a late-breaking oral presentation at the ESMO 2026 Congress, with simultaneous publication in The Lancet.

Efficacy Results

The trial compared iza-bren, an investigational dual-targeting EGFRxHER3 bispecific antibody-drug conjugate, with platinum-based chemotherapy in patients previously treated with an EGFR tyrosine kinase inhibitor. With median follow-up of 14.6 months, iza-bren (n=216) improved the primary endpoint of progression-free survival, with a median of 11.1 months versus 5.7 months for chemotherapy (n=206) by blinded independent central review (HR 0.40; 95% CI 0.31 to 0.51; p<0.0001).

The confirmed objective response rate was 60.2% versus 34.5%, and the median duration of response was 10.4 months versus 5.7 months. Overall survival, a secondary endpoint, was immature, though the companies reported a favorable trend toward improvement with iza-bren.

Safety Profile and Program Context

The companies reported a manageable safety profile with no new safety signals. Grade 3 or higher treatment-related adverse events were mainly hematologic and managed with standard supportive care. Only 1.9% of patients in the iza-bren group discontinued treatment because of treatment-related adverse events, and adjudicated interstitial lung disease occurred in two patients (0.9%), one Grade 3 and one Grade 1.

PANKU-Lung01 is described as the first Phase 3 trial to evaluate a dual-targeting EGFRxHER3 bispecific antibody-drug conjugate in this patient population. The companies state that iza-bren has now demonstrated clinical benefit in five distinct tumor types. SystImmune is a clinical-stage biotechnology company, and Bristol Myers Squibb is its development partner.

Iza-bren has demonstrated clinical benefit across five Phase 3 trials in five indications: previously treated EGFR-mutated NSCLC, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, triple-negative breast cancer and HR-positive, HER2-negative breast cancer. It has also received Breakthrough Therapy Designation from the U.S. FDA for previously treated advanced EGFR-mutated NSCLC. PANKU-Lung01 is sponsored by Biokin in mainland China, and outside China iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and license agreement.

Why This Could Matter

The release provides randomized Phase 3 data for an investigational drug in a setting where, per the investigators quoted, chemotherapy has often been the default after EGFR TKI therapy. The progression-free survival figures are interim and overall survival is not yet mature, so the dataset does not yet answer the survival question. Iza-bren remains investigational.

Iza-bren is a bispecific antibody-drug conjugate that targets EGFR and HER3 and carries a topoisomerase 1 inhibitor payload, which the companies say causes cytotoxic stress leading to cancer cell death while also blocking EGFR and HER3 signalling. Bristol Myers Squibb's chief medical officer said the company is committed to advancing the drug with urgency.

The Bottom Line

The PANKU-Lung01 interim analysis reported a median progression-free survival of 11.1 months for iza-bren against 5.7 months for chemotherapy, with response and safety data supporting the companies' description of the results as positive.