LEADS BIOLABS-B (09887.HK): Updated LBL-034 Data in RRMM Presented at ESMO

NewTimeSpace News: On 25 October 2026, Nanjing Leads Biolabs Co., Ltd. (stock code: 9887) announced that updated results from the first-in-human study of LBL-034, a GPRC5D/CD3 bispecific T-cell engager, in relapsed or refractory multiple myeloma (RRMM) were presented as an oral presentation at the 2026 Congress of the European Society for Medical Oncology (ESMO) on 24 October 2026.

As at the data cut-off date of 16 July 2026, the study had enrolled 56 heavily pretreated RRMM patients with a median of 4.5 prior lines of therapy (range 3 to 12). Among them, 73.2% were triple-class exposed, 57.1% penta-drug exposed and 60.7% triple-class refractory; 28.6% and 16.1% had received autologous stem cell transplant and BCMA-directed CAR-T therapy respectively, 23.2% had extramedullary disease and 64.3% had high-risk cytogenetics.

In terms of efficacy, among 41 patients treated at effective dose levels of 400 to 1,200μg/kg, with a median follow-up of 17.8 months, median progression-free survival (PFS) was 21.8 months (data immature) and median duration of response was not reached; 15-month and 18-month PFS rates were 62.0% and 54.8%, while 12-month and 18-month DoR rates were 77.0% and 68.4%. The objective response rate (ORR) was 75.0% in patients with extramedullary disease and reached 100% in the 1,200μg/kg cohort; in patients who had failed prior BCMA-targeted therapy, the ORR was 85.7% with a strict complete response rate of 57.1%; in penta-drug exposed patients, the ORR was 73.9% and the sCR rate 34.8%.

On safety, no dose-limiting toxicity was observed up to 1,200μg/kg and the maximum tolerated dose was not reached. Cytokine release syndrome was predominantly low grade, with only one grade 3 or above event; two cases of immune effector cell-associated neurotoxicity syndrome fully recovered, and no neurotoxicity associated with movement disorders or ataxia was reported. Median treatment exposure was 11.3 months. LBL-034 received orphan drug designation from the FDA in October 2024 and fast track designation in January 2026, and a Phase III trial is being prepared.