百时美施贵宝，SystImmune目前口服安全性，来自Iza-Bren治疗晚期实体瘤的全球I期US-Lung-101试验的疗效结果;数据显示在不同肿瘤类型中具有良好的抗肿瘤活性，安全性特征可控

REDMOND, Wash. and PRINCETON, N.J., Oct. 17, 2025 /PRNewswire/ -- SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE:BMY) today announced the oral presentation of the first disclosure of the safety and efficacy data from the global phase I US-Lung-101 study (NCT05983432) of iza-bren (BL-B01D1), a potentially first-in-class EGFR x HER3 bispecific antibody-drug conjugate (ADC), at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany. Iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of Mainland China. In August 2025, iza-bren was granted breakthrough therapy designation by U.S. FDA for patients with previously treated EGFR-mutated NSCLC based on the data from China studies and this global study.

This study evaluated the safety and efficacy of iza-bren in global patients with heavily pre-treated metastatic or unresectable advanced non-small cell lung cancer (NSCLC) and other solid tumors. At the data cut-off (DCO) of July 23, 2025, iza-bren has demonstrated:

• Promising antitumor activity in heavily pre-treated patients across multiple tumor types, including EGFR mutant and wildtype NSCLC
• Manageable safety profile, with hematologic adverse events effectively managed by standard medical measures, and no interstitial lung disease was observed

In the study, 107 patients with advanced solid tumors were treated, including non-small cell lung cancer (NSCLC) patients with and without EGFR mutations. Most had received several prior therapies. The most common side effects were blood-related, such as neutropenia. These were generally manageable and rarely led to dose reductions or serious complications. No new safety concerns were identified, and no cases of interstitial lung disease were seen. Mandatory preventive measures for neutropenia have been added in ongoing global studies.