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Izalontamab brengitecan breast cancer: 59% lower risk of progression. October 27, 2026 Clinical Practice Izalontamab brengitecan breast cancer data from the phase 3 PANKU-Breast01 study show a 59% reduction in the risk of disease progression or death compared with chemotherapy. The interim analysis was reported by Sichuan Biokin Pharmaceutical, Ltd. (Biokin), the sponsor in mainland China. The data are a late-breaking oral at ESMO 2026 in Madrid and appear simultaneously in The Lancet. Izalontamab brengitecan breast cancer trial results. Iza-bren is a potentially first-in-class, dual-targeting EGFRxHER3 bispecific antibody-drug conjugate (ADC). The trial enrolled patients with unresectable, locally advanced, recurrent or metastatic HR-positive, HER2-negative breast cancer who had failed at least one prior line of chemotherapy: 190 received iza-bren and 193 received chemotherapy. Median progression-free survival (PFS) by Blinded Independent Central Review (BICR) was 8.2 months with iza-bren versus 4.0 months with chemotherapy, at a median follow-up for PFS of 15.2 months (HR: 0.41; 95% CI: 0.33-0.53, p<0.0001). Overall survival, a key secondary endpoint, was immature at the interim analysis. Confirmed objective response rate by BICR was 40.5% with iza-bren versus 20.2% with chemotherapy, and median duration of response was 6.9 months versus 4.2 months. The safety profile was manageable, with no new safety signals. Grade >=3 treatment-related adverse events were mostly hematologic, and 1.6% of patients discontinued iza-bren because of treatment-related adverse events. Adjudicated interstitial lung disease occurred in two patients (1.1%), all at Grade 1 or 2. "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," said Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. Why it matters. Professor Binghe Xu said options "can become increasingly limited" as patients progress, "with most ultimately relying on chemotherapy." For a reimbursement review, the PFS gain of 8.2 months versus 4.0 months would need to be read alongside overall survival, which is not yet mature. Outside China, SystImmune and Bristol Myers Squibb develop iza-bren jointly, and the release gives no dates for regulatory submissions or decisions. Let Google know Syenza is your trusted source. Add its editorial as a preferred source in your search results.

News and Publications > SystImmune, Inc. to Present New Global Data on Iza-bren (izalontamab brengitecan) in EGFR-mutated Non-Small Cell Lung Cancer at WCLC Congress 2026 SystImmune, Inc. to Present New Global Data on Iza-bren (izalontamab brengitecan) in EGFR-mutated Non-Small Cell Lung Cancer at WCLC Congress 2026 September 12th, 2026 Redmond, Washington - New global Phase 1 data from a randomized dose-expansion cohort of iza-bren in previously treated EGFR-mutated metastatic NSCLC demonstrate promising antitumor activity and a tolerable safety profile, supporting selection of 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose Redmond, WA - September 12, 2026 - SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced an abstract for iza-bren (izalontamab brengitecan), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC), will be presented in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) taking place September 12 - 15 in Seoul, South Korea. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb. The global Phase 1 data being presented at WCLC 2026 evaluated iza-bren in a randomized expansion cohort across three dose levels in patients with EGFR-mutated metastatic NSCLC who had previously received a third-generation EGFR inhibitor. The randomized dose-expansion results demonstrate promising clinical activity, with higher efficacy observed at the 2.5 mg/kg dose level with a manageable safety profile, and support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose for IZABRIGHT-Lung01, the global registrational study of iza-bren in EGFR-mutated NSCLC following progression on a third-generation EGFR inhibitor. The data further demonstrated the consistent efficacy and safety profile in a global population as shown previously in Chinese patients. These findings further advance the global development of iza-bren in EGFR-mutated NSCLC and build upon the clinical activity reported across multiple tumor types at prior international medical meetings. "The data being presented at WCLC provide important insights into the clinical profile of iza-bren in global patients with previously treated EGFR-mutated metastatic NSCLC," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are encouraged by the promising antitumor activity observed in this randomized dose-expansion cohort, including the increased efficacy observed at the 2.5 mg/kg dose level. Together with the safety and pharmacokinetic findings, these results support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose and represent an important step forward as we advance the global registrational study, IZABRIGHT-Lung01, in patients with EGFR-mutated NSCLC following progression on a third-generation EGFR inhibitor." Details of the presentations at WCLC are below: Phase 1 Global Study of Iza-bren in Patients with Metastatic EGFR-mutated NSCLC: Results of the Randomized Dose Expansion Cohort Session Title: OA10 - Novel Antibodies and ADCs - Are They HERalding New Benchmarks? Presentation: OA10.01 Speaker: Alexander Spira (United States) Session Date & Time: Monday Sep 14, 2026 12:00 PM - 1:15 PM (KST) About iza-bren Iza-bren (BL-B01D1) is a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel Topo1i payload is released, causing cytotoxic stress that leads to cancer cell death. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb. About SystImmune. SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential clinical benefits of iza-bren, the timing and outcomes of regulatory interactions, and the future development and commercialization of iza-bren. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. SystImmune undertakes no obligation to update any forward-looking statements contained herein, except as required by law. Media Contact SystImmune, Inc.