The following is a summary of “Anti-LAG-3 antibody LBL-007 plus anti-PD-1 antibody toripalimab in advanced nasopharyngeal carcinoma and other solid tumors: an open-label, multicenter, phase Ib/II trial,” published in the February 2025 issue of Journal of Hematology & Oncology by Chen et al.
Researchers conducted a prospective study on the safety and efficacy of LBL-007 plus toripalimab in patients with previously treated advanced nasopharyngeal carcinoma (NPC) and other solid tumors.
They enrolled patients with advanced tumors refractory to prior therapies. They administered LBL-007 (200 mg or 400 mg) plus toripalimab (240 mg) every 3 weeks in phase Ib and LBL-007 at the recommended phase II dose (RP2D) plus toripalimab (240 mg) every 3 weeks in phase II. Primary endpoints were safety (phase Ib) and objective response rate (ORR) (phase II), with an exploratory endpoint assessing LAG-3 and PD-L1 expression for efficacy.
The results showed that 80 patients (30 NPC, 50 other tumors) were enrolled with a median follow-up of 26.0 months. In phase Ib, LBL-007 was given at 200 mg (n=4) and 400 mg (n=6) with no dose-limiting toxicities (DLTs), establishing 400 mg as RP2D for phase II (n=70). Grade 3 or 4 treatment-related adverse events occurred in 9 (11.3%) of 80 patients (anemia 2.5%, hyponatremia 2.5%, ALT increase 2.5%, AST increase 1.3%, fatigue 1.3%), and 8 (10.0%) had serious adverse events. No treatment-related deaths occurred. In immunotherapy-naive NPC (n=12), ORR was 33.3%, DCR 75%, and median progression-free survival (PFS) 10.8 months. In IO-treated NPC (n=17), ORR was 11.8%, DCR 64.7%, and median PFS 2.7 months. In other tumors, ORRs were 15.8% in immunotherapy-naive and 3.7% in IO-treated patients. ORR was higher in patients with ≥2+ LAG-3 expression (28.0%) than those with <2+ (7.7%).
Investigators found that LBL-007 plus toripalimab was safe in advanced solid tumors and showed promising efficacy in NPC, especially in patients with immunotherapy-naive, warranting further validation.
Source: jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01666-6
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