https://scholars.lib.ntu.edu.tw/handle/123456789/638436
標題: | A phase 2, multicenter, open-label study of anti-LAG-3 ieramilimab in combination with anti-PD-1 spartalizumab in patients with advanced solid malignancies | 作者: | CHIA-CHI LIN Garralda, Elena Schöffski, Patrick Hong, David S Siu, Lillian L Martin, Miguel Maur, Michela Hui, Rina Soo, Ross A Chiu, Joanne Zhang, Tian Ma, Brigette Kyi, Chrisann Tan, Daniel Sw Cassier, Philippe A Sarantopoulos, John Weickhardt, Andrew Carvajal, Richard D Spratlin, Jennifer Esaki, Taito Rolland, Fréderic Akerley, Wallace Deschler-Baier, Barbara Rispoli, Lawrence Samant, Tanay S Chowdhury, Niladri Roy Gusenleitner, Daniel Kwak, Eunice L Askoxylakis, Vasileios De Braud, Filippo |
關鍵字: | Efficacy; LAG-3 inhibitor; ieramilimab; safety; spartalizumab | 公開日期: | 2024 | 卷: | 13 | 期: | 1 | 來源出版物: | Oncoimmunology | 摘要: | Ieramilimab, a humanized anti-LAG-3 monoclonal antibody, was well tolerated in combination with the anti-PD-1 antibody spartalizumab in a phase 1 study. This phase 2 study aimed to further investigate the efficacy and safety of combination treatment in patients with selected advanced (locally advanced or metastatic) solid malignancies. Eligible patients with non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), mesothelioma, and triple-negative breast cancer (TNBC) were grouped depending on prior anti-PD-1/L1 therapy (anti-PD-1/L1 naive or anti-PD-1/L1 pretreated). Patients received ieramilimab (400 mg) followed by spartalizumab (300 mg) every 3 weeks. The primary endpoint was objective response rate (ORR), along with safety, pharmacokinetics, and biomarker assessments. Of 235 patients, 142 were naive to anti-PD-1/L1 and 93 were pretreated with anti-PD-1/L1 antibodies. Durable responses (>24 months) were seen across all indications for patients naive to anti-PD-1/L1 and in melanoma and RCC patients pretreated with anti-PD1/L1. The most frequent study drug-related AEs were pruritus (15.5%), fatigue (10.6%), and rash (10.6%) in patients naive to anti-PD-1/L1 and fatigue (18.3%), rash (14.0%), and nausea (10.8%) in anti-PD-1/L1 pretreated patients. Biomarker assessment indicated higher expression of T-cell-inflamed gene signature at baseline among responding patients. Response to treatment was durable (>24 months) in some patients across all enrolled indications, and safety findings were in accordance with previous and current studies exploring LAG-3/PD-1 blockade. |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/638436 | ISSN: | 21624011 | DOI: | 10.1080/2162402X.2023.2290787 |
顯示於: | 臨床醫學研究所 |
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