By Fineline Cube 
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) reported Phase 1/2 data for LBL-034 in relapsed/refractory multiple myeloma at the 67th ASH Annual Meeting. The bispecific T‑cell engager targeting GPRC5D and CD3 demonstrated strong efficacy with 82.5% ORR and a favorable safety profile with no dose‑limiting toxicities observed up to 1,200 μg/kg.
Drug Profile & Mechanism
LBL-034 is a bispecific T‑cell engager (TCE) that simultaneously targets:
- GPRC5D: A novel antigen highly expressed on multiple myeloma cells
- CD3: T‑cell receptor component to redirect immune response
Design Advantages:
- Sub-nanomolar affinity for potent tumor cell engagement
- Tumor-selective activation minimizes off-tumor toxicity
- Graduated dosing allows for safety titration
Phase 1/2 Study Design & Safety
| Study Parameter | Details |
|---|---|
| Study Design | Phase 1/2 dose-escalation and expansion |
| Patient Population | Relapsed/refractory multiple myeloma |
| Dose Range Tested | Up to 1,200 μg/kg |
| Dose-Limiting Toxicity (DLT) | None observed |
| Maximum Tolerated Dose (MTD) | Not reached |
| Related Adverse Events | All Grade 1‑2, primarily Cycle 1; decreased in subsequent cycles |
| Quality-of-Life Toxicities | Taste, skin, nail toxicities infrequent and self-resolving |
Safety Summary: No treatment discontinuations due to adverse events; most AEs managed with supportive care.
Efficacy Results (400–1,200 μg/kg dose range, n=40)
| Endpoint | Result | Clinical Significance |
|---|---|---|
| Objective Response Rate (ORR) | 82.5% | Strong anti-tumor activity |
| ≥ Complete Response (CR) | 52.5% | Deep responses |
| ≥ Very Good Partial Response (VGPR) | 72.5% | High-quality responses |
| MRD Negativity | 80.0% | Minimal residual disease clearance |
| 12‑Month PFS Rate | 61.2% | Durable disease control |
Dose‑Specific Efficacy (800 μg/kg):
- ORR: 90.9%
- ≥CR: 63.6%
Key Insight: 800 μg/kg dose level shows optimal efficacy/safety balance, likely to be recommended Phase 2 dose.
Market Context & Strategic Outlook
- Multiple Myeloma Burden: China has ~30,000 new cases annually; R/R population represents ~40% (12,000 patients)
- GPRC5D Landscape: Emerging target with limited competition; Talquetamab (J&J) approved in US but not yet in China
- CAR‑T vs. TCE: TCEs offer off-the-shelf convenience vs. autologous CAR‑T; LBL-034 positions as leading GPRC5D bispecific
- Commercial Potential: Analysts project ¥3-5 billion (≈ US$420-700 million) peak sales if approved
- Next Milestones: Phase 2 expansion cohort ongoing; registration-enabling study initiation planned for H1 2026
Forward‑Looking Statements
This brief contains forward‑looking statements regarding LBL-034 development timelines, clinical outcomes, and market potential. Actual results may differ due to clinical, regulatory, and competitive uncertainties.-Fineline Info & Tech