1. Anlotinib plus TQB2450, a PD-L1 Antibody, in Patients with Advanced Alveolar Soft Part Sarcoma: A Single-Arm, Phase II Trial.
- Author
-
Tan Z, Wu Y, Fan Z, Gao T, Guo W, Bai C, Xue R, Li S, Zhang L, Wang X, Jia L, and Liu J
- Subjects
- Humans, Male, Female, Adult, Middle Aged, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Aged, Prognosis, Immune Checkpoint Inhibitors administration & dosage, Immune Checkpoint Inhibitors therapeutic use, Immune Checkpoint Inhibitors adverse effects, Progression-Free Survival, Indoles administration & dosage, Indoles therapeutic use, Indoles adverse effects, Quinolines administration & dosage, Quinolines adverse effects, Quinolines therapeutic use, Sarcoma, Alveolar Soft Part drug therapy, Sarcoma, Alveolar Soft Part pathology, B7-H1 Antigen antagonists & inhibitors
- Abstract
Purpose: Alveolar soft part sarcoma (ASPS) is an ultrarare soft-tissue sarcoma with a high rate of metastasis and no established treatment. This study aimed to explore the efficacy and safety of anlotinib (a tyrosine kinase inhibitor) and TQB2450 (a PD-L1 inhibitor) in patients with ASPS., Patients and Methods: This single-arm, phase II study evaluated the efficacy of TQB2450, an anti-PD-L1 agent, combined with anlotinib, a tyrosine kinase inhibitor, in adults with advanced ASPS. TQB2450 was given intravenously (1,200 mg) on day 1, and anlotinib (12 mg/day) was taken orally from day 1 to 14 every 3 weeks. The primary endpoint was overall response rate, with secondary endpoints including duration of response, progression-free survival, and overall survival. Lymphocyte infiltration and tertiary lymphoid structure (TLS) were also analyzed as potential prognostic biomarkers., Results: The study enrolled 29 patients, of whom 28 were evaluable (one withdrew because of acute pancreatitis). An objective response was achieved in 82.1% of patients, including 4 complete and 19 partial responses. The median time to response was 2.8 months, and the duration of response was not reached, with an estimated median progression-free survival of 35.2 months. Grade 3 to 4 treatment-related adverse events occurred in 44.8% of patients, with no study-related deaths. Responders had a higher proportion of TLS area, TLS density, and CD20-positive immune cells., Conclusions: The combination of anlotinib and TQB2450 is effective and tolerable in patients with ASPS. TLS may serve as a prognostic biomarker, meriting further investigation., (©2024 American Association for Cancer Research.)
- Published
- 2024
- Full Text
- View/download PDF