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Lin, Chia-Chi; 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
Oncoimmunology, 2024, Letnik: 13, Številka: 1Journal Article
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.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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