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SUMMARY
This open-label, international Phase 2 study evaluated tislelizumab (TIS), an investigational anti-programmed cell death protein 1 (PD-1) monoclonal antibody, alone or in combination with surzebiclimab (SUR), an anti-T-cell immunoglobulin and mucin domain-containing protein 3 (TIM3) agent, and/or alcestobart (LBL-007), an anti-lymphocyte-activation gene 3 (LAG3) agent as first-line treatment in patients with recurrent and/or metastatic head and neck squamous cell carcinoma with PD-L1 combined positive score ≥1. Patients were randomized to receive TIS monotherapy (Arm A), TIS + SUR (Arm B), TIS + LBL-007 (Arm C), or TIS + SUR + LBL-007 (Arm D). The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST v1.1. As of June 17, 2025, 160 patients were enrolled, with 40 patients per arm and a median follow-up of 13.1 months. Confirmed ORRs were 27.5% in Arms A, B, and D and 25.0% in Arm C. The most common treatment-emergent adverse events were anemia, hypothyroidism, and increased aspartate aminotransferase. Overall, efficacy was comparable across treatment arms, and all regimens were generally well tolerated with manageable toxicities.
ClinicalTrials.gov ID: NCT05909904
| Population | Intervention | Comparator | Outcome Measures |
|---|---|---|---|
| Adults (≥18 years) with histologically or cytologically confirmed recurrent and/or metastatic head and neck squamous cell carcinoma and programmed cell death ligand 1 combined positive score ≥1. | Tislelizumab monotherapy or tislelizumab in combination with surzebiclimab and/or alcestobart | N/A |
|
The study evaluated tislelizumab (TIS), an investigational anti-programmed cell death protein 1 (PD-1) monoclonal antibody, alone or in combination with surzebiclimab (SUR), an anti-T-cell immunoglobulin and mucin domain-containing protein 3 (TIM3) agent, and/or alcestobart (LBL-007), an anti-lymphocyte-activation gene 3 (LAG3) agent as first-line treatment in adults with recurrent and/or metastatic head and neck squamous cell carcinoma who had PD-L1 with a combined positive score ≥1.
This was an open-label, international Phase 2 randomized study with 4 treatment arms assessing TIS monotherapy and combination regimens. Patients were assigned to receive either TIS monotherapy (Arm A), TIS + SUR (Arm B), TIS + LBL-007 (Arm C), or TIS + SUR + LBL-007 (Arm D). The primary endpoint was investigator-assessed objective response rate per RECIST v1.1. Secondary endpoints included clinical benefit rate (CBR), disease control rate (DCR), and assessments of safety and tolerability.
As of June 17, 2025, a total of 160 patients were enrolled in the study, with 40 patients allocated to each treatment arm. The overall cohort had a median age of 64 (range, 22-84) years. The majority of patients were male (84.4%) and Asian (70.6%). Most participants had an Eastern Cooperative Oncology Group Performance Status of 1 (52.5%) and identified the oral cavity as the primary site of their disease (42.5%). Additionally, 60.0% of the patients had previously received platinum-based chemotherapy. The median follow-up time for the study was 13.1 (range, 0.1-21.2) months.
Confirmed objective response rates were 27.5% in Arms A, B, and D and 25.0% in Arm C. Complete responses were reported in 3 of 40 patients in Arm C and in 2 of 40 patients in Arm D. The CBR (95% CI) was 32.5% (18.6-49.1) in Arm A, 37.5% (22.7-54.2) in Arms B and D, and 35.0% (20.6-51.7) in Arm C. The DCR (95% CI) was 55.0% (38.5-70.7), 67.5% (50.9-81.4), 62.5 (45.8-77.3), and 65.0 (48.3-79.4) in Arms A, B, C, and D, respectively.
Treatment was generally well tolerated across all arms, with manageable toxicities. The most common treatment-emergent adverse events (TEAEs) in the overall cohort were anemia (23.3%), hypothyroidism (18.9%), and increased aspartate aminotransferase (15.1%). Treatment-related TEAEs occurred in 61.5% to 77.5% of patients across arms. Fatal TEAEs occurred in 5.7% of patients and were not treatment related. Immune-mediated adverse events, mostly grade 1 or 2, occurred in 35.2% of patients in the overall cohort. Infusion-related reactions occurred in 6.9% of patients in the overall cohort, with only one grade ≥3 event reported in Arm A.
