Clinical trial results of Leads Biolabs' LBL-007（anti-LAG-3 mAb）combined with anti-PD-1 mAb in advanced nasopharyngeal carcinoma and other solid tumors published in Journal of Hematology & Oncology

In February 2025, the Phase Ib/II clinical trial results of LBL-007, a novel LAG-3 antibody independently developed by Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs"), was published in the prestigious Journal of Hematology & Oncology (Impact Factor: 29.9). This study, led by Professor Li Zhang and Yunpeng Yang from Sun Yat-sen University Cancer Center, is the first clinical trial to assess the efficacy of anti-LAG-3/PD-1 combination therapy in nasopharyngeal carcinoma (NPC) patients.

Figure 1: Screenshot of the Paper

Key Findings: Promising Antitumor Activity and Manageable Safety

Among the immunotherapy-naive NPC patients, the objective response rate (ORR) was 33.3%, the disease control rate (DCR) was 75%, the median progression-free survival (PFS) was 10.8 months, and the median duration of response (DOR) was 15 months.

Favorable therapeutic effects were also observed in patients with esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), and squamous Non-small cell lung cancer (sqNSCLC), particularly in those with sqNSCLC, where the ORR was 25.0%.

In the dose-escalation stage of phase Ib, no dose-limiting toxicity (DLT) was observed. The recommended phase II dose of LBL-007 is 400mg. The combination of LBL-007 and toripalimab has good overall safety in patients with solid tumors. Treatment-emergent adverse events (TEAEs) are mainly grade 1-2, and there are no treatment-related death events.

It is worth noting that better efficacy of the combination therapy is observed in patients with high LAG-3 expression (IHC ≥2+), with the objective response rate reaching 28.0%, while in patients with low expression, the objective response rate is only 7.7%.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, commented: "LBL-007's clinical data published in the Journal of Hematology & Oncology validates the scientific rigor and superior efficacy of this innovative therapy. Additionally, our recently completed Phase II study on the 1^st line treatment of NPC with LBL-007 in combination with PD-1 monoclonal antibody and chemotherapy has obtained exceptionally promising results, which will be presented at 2025 ASCO Annual Meeting. These encouraging results highlight LBL-007's immense clinical potential and bring new hope for treating nasopharyngeal carcinoma and other solid tumors. Currently, Phase II trials evaluating LBL-007 based combination therapies in multiple cancer indications are actively underway. We remain committed to accelerating development and expanding its therapeutic scope, with the goal of benefiting more patients."