Phase II Trial of Pembrolizumab in Combination With Bevacizumab for Untreated Melanoma Brain Metastases.

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Tác giả: Adebowale Adeniran, Gail Anderson, Matthew Austin, Veronica Chiang, Justine Cohen, Dijana Djureinovic, Zeynep Eroglu, Peter Forsyth, Sarah Goldberg, Upendra Hegde, Lucia Jilaveanu, Barbara Johnson, Nikhil I Khushalani, Harriet M Kluger, Amit Mahajan, Joseph Markowitz, Cecily Piteo, Mario Sznol, Thuy Tran, Wei Wei, Sarah A Weiss

Ngôn ngữ: eng

Ký hiệu phân loại: 373.236 Lower level

Thông tin xuất bản: United States : Journal of clinical oncology : official journal of the American Society of Clinical Oncology , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 693086

PURPOSE: Anti-vascular endothelial growth factor therapy enhances PD-1 inhibitor activity in preclinical models and has been used to treat perilesional cerebral edema and radiation necrosis. METHODS: We conducted a two-institution phase II trial of bevacizumab and pembrolizumab in patients with untreated melanoma brain metastasis (MBM) (ClinicalTrials.gov identifier: NCT02681549). Patients were anti-PD-(L)-1-naïve, and had ≥one asymptomatic, nonhemorrhagic 5-20 mm MBM, not requiring immediate local therapy or steroids. RESULTS: Thirty-seven patients received four doses of bevacizumab and pembrolizumab every 3 weeks followed by up to 2 years of pembrolizumab. The brain metastasis response rate (primary end point) was 54.1% (95% CI, 36.9 to 70.5). The extracranial response rate was 56.3% (95% CI, 37.7 to 73.6). Median intracranial progression-free survival was 2.2 years (95% CI, 0.41 to not reached [NR]). Median overall survival (OS) was 4.3 years (95% CI, 1.6 to NR). Four-year OS rate was 51.6%. Grade 3 treatment-related adverse event rates from bevacizumab and pembrolizumab were 10.8% and 18.9%, respectively. Higher pretreatment vessel density in metastatic tumors and smaller on-therapy increases in circulating angiopoietin-2 were associated with response. CONCLUSION: Pembrolizumab with bevacizumab was well tolerated and demonstrated substantial activity in patients with untreated MBM with promising OS, justifying further evaluation of this regimen.
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