At the 2025 American Society of Hematology (ASH) Annual Meeting, Sino Biopharm (1177.HK) announced the Phase I study results for TQB2934 for injection (a BCMA×CD3 bispecific antibody) in treating patients with relapsed/refractory multiple myeloma (R/R MM) in a poster presentation. This is an update following the initial clinical data release for TQB2934 at the 2024 ASH Annual Meeting. The latest study data suggest that TQB2934 demonstrates manageable safety and significant clinical activity, showing promise as a new treatment option for patients with relapsed/refractory multiple myeloma. 

Multiple Myeloma (MM) is a hematologic neoplasm malignant, accounting for 10%-15% of all hematologic malignancies worldwide. Although the emergence of novel therapies such as new proteasome inhibitors, new immunomodulatory drugs, anti-CD38 monoclonal antibodies, and CAR-T has greatly improved the prognosis for these patients, MM remains an incurable hematologic malignancy. It progresses rapidly, and the prognosis is poor at the relapsed/refractory multiple myeloma (R/R MM) stage. 

TQB2934 is a novel 2+1 BCMA×CD3 bispecific antibody independently developed by Chia Tai Tianqing. It targets myeloma cells expressing BCMA and T-cells expressing CD3, thereby activating T-cells and inducing apoptosis in myeloma cells. In addition to its use in the treatment of MM, the development of an indication for the treatment of systemic light-chain (AL) amyloidosis in adults is also in the Phase Ib/II clinical stage. 

The TQB2934 study announced at this annual meeting is a Phase I, single-arm, open-label clinical trial, including dose-escalation and expansion phases, conducted by the team of Professor Liu Peng, Director of the Department of Hematology at Zhongshan Hospital, Fudan University. As of October 2025, the study had enrolled a total of 60 R/R MM patients. The median number of prior lines of therapy was 3. Among the enrolled patients, 47% had high-risk cytogenetic abnormalities, 22% had extramedullary disease, and 82% were at R-ISS (Revised International Staging System) stage II-III. 

The study results^[1] showed that among 57 evaluable R/R MM patients, the overall objective response rate (ORR) was 63.2%, the rate of ≥very good partial response (VGPR) was 54.4%, and the rate of ≥complete response (CR) was 42.1%. Efficacy data such as ORR/VGPR/CR showed a progressive increase with dose escalation. In the 40 mg target dose group, the ORR reached 77.4%, and the rates of ≥VGPR and ≥CR were 64.5% and 45.2%, respectively. 

In terms of safety, the overall incidence of TQB2934 treatment-related adverse events (TRAEs) was 96.7%, with ≥Grade 3 TRAEs at 78.3%. The most common adverse reactions were mainly hematologic toxicity, cytokine release syndrome (CRS), hypocalcaemia, pyrexia, and diarrhoea. CRS was mainly Grade 1-2, often occurred after the first target dose, and resolved within 3 days, indicating overall manageable safety of TQB2934. 

Pharmacokinetic (PK) results showed that drug exposure increased proportionally with dose escalation, with no significant drug accumulation. Pharmacodynamic (PD) results indicated a significant correlation between changes in serum soluble BCMA levels and clinical response, providing direct support for the drug's mechanism of action. Based on a comprehensive analysis of efficacy, safety, and PK/PD, 40 mg was determined as the recommended Phase II dose (RP2D) for TQB2934. 

The latest Phase I results indicate that TQB2934 for injection shows manageable safety and significant clinical activity in heavily pretreated R/R MM patients, positioning it as a promising new treatment option for patients with relapsed/refractory myeloma. A Phase III study is currently being planned to further validate the efficacy and safety of TQB2934 in R/R MM patients after multiple lines of therapy. 

References:
[1] Peng Liu,et al.Updated results of TQB2934, a novel 2+1 BCMA×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma: A phase I study.2025ASH.

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