映恩生物-B(09606)：核心产品DB-1311/BNT324于2026年美国临床肿瘤学会泌尿生殖系统癌症研讨会上公布的研究结果

Core Viewpoint - The company, Immune-Onc Therapeutics, is set to present the latest efficacy and safety results of its investigational B7H3 antibody-drug conjugate, DB-1311/BNT324, for treating previously treated metastatic castration-resistant prostate cancer (mCRPC) patients at the 2026 ASCO GU Cancer Symposium [1]. Group 1: Study Overview - The 1/2 phase study (NCT05914116) involves a dose-optimization cohort where mCRPC patients previously treated received DB-1311/BNT324 at doses of 6 mg/kg or 9 mg/kg every three weeks [1]. - In the dose-expansion cohort, patients who had received Lu 177 treatment and those who had not received taxane therapy were administered 6 mg/kg every three weeks until disease progression or intolerable toxicity occurred [1]. Group 2: Patient Demographics and Treatment Outcomes - As of September 5, 2025, 104 mCRPC patients had received DB-1311/BNT324 treatment, with a median follow-up of 9.2 months; 50% of patients remained on treatment [2]. - The median age of patients was 70 years, with a majority being white (53%), followed by Asian (31%) and Black (13%); the median number of prior treatments was 4 [2]. - Among 58 patients eligible for tumor response assessment, the unconfirmed objective response rate was 41.4%, and the confirmed objective response rate was 34.5%, with a disease control rate of 87.9% [2]. Group 3: Progression-Free Survival and Overall Survival - In 82 patients evaluable for radiographic progression-free survival (rPFS), the median rPFS was 11.3 months, with 6-month and 9-month rPFS rates of 72.0% and 63.0%, respectively [2]. - Overall survival (OS) data was not yet mature, but the 6-month and 9-month OS rates were reported at 91.7% and 88.2% [3]. Group 4: Safety Profile - The safety profile was consistent with previous reports, with the most common adverse events being nausea and hematological events, primarily grade 1-2 [3]. - Among the 104 patients, 34 (33%) had previously received Lu 177 treatment, with similar outcomes observed between those who had and had not received Lu 177, although the PSA duration of response was shorter in the former group [3].