Core Viewpoint - The company, Wuxi Biologics, is set to present its innovative GPRC5D/CD3 bispecific antibody LBL-034 for treating relapsed/refractory multiple myeloma (RRMM) at the 67th ASH Annual Meeting, showcasing promising clinical results and safety profile [1][2]. Group 1: Clinical Research Highlights - LBL-034's I/II clinical trial, led by Professor Lu Jin from Peking University People's Hospital, demonstrated good safety and encouraging anti-tumor activity in RRMM patients, including those with high-risk features [1]. - No dose-limiting toxicities (DLT) were observed at doses up to 1,200 μg/kg, and the maximum tolerated dose (MTD) has not been reached [1]. - Adverse events related to quality of life were mostly grade 1-2 and primarily occurred during the first treatment cycle, with significantly reduced incidence in subsequent treatments [1]. Group 2: Efficacy Data - In the dose range of 400 to 1,200 μg/kg (n=40), the objective response rate (ORR) was 82.5%, with a complete response (CR) rate of 52.5% and a very good partial response (VGPR) rate of 72.5% [2]. - At the 800 μg/kg dose level, ORR and CR rates increased to 90.9% and 63.6%, respectively [2]. - In patients with extramedullary disease (EMD), the ORR was 75.0%, with two cases achieving stringent complete response (sCR), and in the 1,200 μg/kg group, the ORR for EMD patients reached 100% [2]. - The 12-month progression-free survival (PFS) rate was 61.2% with a median follow-up of 9.6 months, and for the 400 μg/kg group (n=11), the median follow-up time was 13.1 months with a 12-month PFS rate of 56.8% [2].
维立志博-B(09887)：LBL-034临床数据于第67届ASH年会发布