{"id":7730,"date":"2026-04-02T16:06:44","date_gmt":"2026-04-02T14:06:44","guid":{"rendered":"https:\/\/beonemedaffairs.com\/us\/?post_type=congress-resource&#038;p=7730"},"modified":"2026-04-02T16:06:44","modified_gmt":"2026-04-02T14:06:44","slug":"phase-2-study-of-tislelizumab-investigational-agents-as-first-line-treatment-in-rm-hnscc","status":"publish","type":"congress-resource","link":"https:\/\/beonemedaffairs.com\/us\/congress-resource\/7730\/phase-2-study-of-tislelizumab-investigational-agents-as-first-line-treatment-in-rm-hnscc\/","title":{"rendered":"A phase 2 study of tislelizumab (TIS) + investigational agents as first-line (1L) treatment in recurrent and\/or metastatic head and neck squamous cell carcinoma (R\/M HNSCC)"},"content":{"rendered":"","protected":false},"template":"","post-tag":[708,569,538],"class_list":["post-7730","congress-resource","type-congress-resource","status-publish","hentry","post-tag-aacr","post-tag-head-and-neck-cancer","post-tag-tislelizumab","congress_resource_type-oral-presentation","content_type-reading","disease_state-head-and-neck-cancer","molecule-tislelizumab"],"acf":{"congress_resource_url_override":"aacr-2026","congress":7069,"category":243,"prioritization":0,"key_data_presentation":false,"key_data_presentation_only":false,"key_data_presentation_prioritization":0,"tags":[538,569,708],"visible_tags":[538,569,708],"content-type":246,"summary":"","text_app":"<strong>DISCLAIMER<\/strong>\r\n\r\n<em>The contents of the presentations above are designed for educational and scientific exchange purposes and are not promotional. They may contain information on investigational products or investigational uses of approved products. No conclusions regarding safety and\/or efficacy for such investigational products or uses may be made.<\/em>\r\n\r\n&nbsp;\r\n\r\n<strong>SUMMARY<\/strong>\r\n\r\nThis 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) and\/or alcestobart (LBL-007) as first-line treatment in patients with recurrent and\/or metastatic head and neck squamous cell carcinoma with PD-L1 combined positive score \u22651 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.\r\n\r\nClinicalTrials.gov ID: NCT05909904","text":"<strong>DISCLAIMER<\/strong>\r\n\r\n<em>The contents of the presentations above are designed for educational and scientific exchange purposes and are not promotional. They may contain information on investigational products or investigational uses of approved products. No conclusions regarding safety and\/or efficacy for such investigational products or uses may be made.<\/em>\r\n\r\n&nbsp;\r\n\r\n<strong>SUMMARY<\/strong>\r\n\r\nThis 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) and\/or alcestobart (LBL-007) as first-line treatment in patients with recurrent and\/or metastatic head and neck squamous cell carcinoma with PD-L1 combined positive score \u22651 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.\r\n\r\nClinicalTrials.gov ID: NCT05909904","table_heading":"PICO TABLE","table":[{"column_1":"Population","column_2":"Intervention","column_3":"Comparator","column_4":"Outcome Measures"},{"column_1":"Adults (\u226518 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 \u22651.","column_2":"Tislelizumab monotherapy or tislelizumab in combination with surzebiclimab and\/or alcestobart","column_3":"N\/A","column_4":"Primary endpoint: Investigator-assessed objective response rate per RECIST v1.1|Secondary endpoints: clinical benefit rate, disease control rate, and safety and tolerability"}],"faq_heading":"FREQUENTLY ASKED QUESTIONS","faq":[{"faq_item_heading":"What was the objective of this study?","faq_item_body":"The study evaluated tislelizumab (TIS), an investigational anti-programmed cell death protein 1 (PD-1) monoclonal antibody, alone or in combination with surzebiclimab (SUR) and\/or alcestobart (LBL-007) 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 \u22651."},{"faq_item_heading":"What was the study design and which endpoints were assessed?","faq_item_body":"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."},{"faq_item_heading":"What were the demographic and baseline characteristics of the study population?","faq_item_body":"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."},{"faq_item_heading":"What were the efficacy findings?","faq_item_body":"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."},{"faq_item_heading":"What were the safety and tolerability findings?","faq_item_body":"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 \u22653 event reported in Arm A."}],"button_alt_link":"","no_post_image_preview":true,"download_file_reading":null,"display_file_reading":null,"download_file_slidekit":null,"display_file_slidekit":null,"3qsdn":"","webcast":"","videolange":null,"fliphtml_link":"","congress_resource_abstract_link":"","congress_resource_cta_label":"","congress_resource_cta_link":"","authors":[7722],"field_page_schema_override":null},"_links":{"self":[{"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/congress-resource\/7730","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/congress-resource"}],"about":[{"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/types\/congress-resource"}],"acf:post":[{"embeddable":true,"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/authors\/7722"},{"embeddable":true,"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/congress\/7069"}],"acf:term":[{"embeddable":true,"taxonomy":"content_type","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/content_type\/246"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/708"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/569"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/538"},{"embeddable":true,"taxonomy":"congress_resource_type","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/congress_resource_type\/243"}],"wp:attachment":[{"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/media?parent=7730"}],"wp:term":[{"taxonomy":"post-tag","embeddable":true,"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag?post=7730"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}