LEADS BIOLABS-B(09887): LBL-034 clinical data will be released at the 67th ASH Annual Meeting.

LEADS BIOLABS-B(09887) announced that the 67th ASH Annual Meeting will be held in Orlando, Florida, USA from December 6th to 9th, 2025. The company's independently developed GPRC5D/CD3 bispecific antibody LBL-034 for the treatment of relapsed/refractory multiple myeloma ("RRMM") will be presented with an oral report on the first day of the conference. The Phase I/II clinical study of LBL-034 was led by Professor Lu Jin from Peking University People's Hospital, conducted at 17 centers nationwide. The study confirmed that LBL-034 demonstrated good safety and exciting anti-tumor activity in RRMM patients (including the difficult-to-treat subgroups with high-risk features), showing the best therapeutic potential in its class. Clinical highlights of LBL-034 include: - The dose of LBL-034 increased to 1,200g/kg without observing any dose-limiting toxicity (DLT) or reaching the maximum tolerated dose (MTD). Adverse events closely related to quality of life were mostly grades 1-2, with most occurring in the first cycle and decreasing significantly in subsequent treatments, not affecting treatment continuity. The occurrence rates of taste, skin, and nail toxicities were low and tended to resolve themselves. - In the dose range of 400 to 1,200g/kg (n=40), the objective response rate (ORR) was 82.5%, with complete response (CR) at 52.5%, and very good partial response (VGPR) at 72.5%, and a minimal residual disease (MRD) negativity rate of 80.0%. At the 800 g/kg dose level, the ORR and CR were even higher at 90.9% and 63.6%, respectively. - Excellent efficacy was also observed in refractory RRMM within the 400 to 1,200 g/kg dose range. For patients with extramedullary disease (EMD), the ORR was 75.0%, with two cases achieving a stringent complete response (sCR). In the 1,200g/kg dose group, the ORR for patients with EMD reached 100%, with a rapid reduction in EMD lesions. In patients previously treated with BCMA-targeted therapy, the ORR was 85.7%, with CR/sCR at 57.1%. - A trend of sustained benefit was observed in the 400 to 1,200 g/kg dose range, with a 12-month progression-free survival (PFS) rate of 61.2% (median follow-up time: 9.6 months). In the 400 g/kg group (n=11), the median follow-up time was 13.1 months, with a 12-month PFS rate of 56.8%.