Page 176 - 2019秋季手冊內頁-ebook測試

演講摘要
ABSTRACT
Highlight on 2019 SITC Conference: Combination Phase 1‐2 Clinical Trials
吳教恩/林口長庚紀念醫院腫瘤科
IL‐2 is a master regulator of adaptive immunity. High dose IL‐2 was approved in mRCC in 1992 and melanoma in 1998 which showed durable curative responses but great toxicity. Previous studies of IL‐2 combinations showed limited efficacy and currently studies of IL‐2 and immune checkpoint inhibitors combination are ongoing.
Bempegaldesleukin (BEMPEG; NKTR‐214) is a CD122‐preferential IL‐2 pathway agonist shown to increase tumor‐infiltrating lymphocytes, T cell clonality and PD‐1 expression. PIVOT‐02, a phase 1/2 study, was to investigate the clinical activity of BEMPEG Plus nivolumab in previously untreated patients with metastatic melanoma showed clinical activity with ORR 53% and CR 34%, in efficacy‐evaluable patients and well‐tolerated toxicity. BEMPEG, in combination with nivolumab, is being further explored in PIVOT IO 001 Melanoma (NCT03635983), PIVOT‐09 RCC (NCT03729245) and PIVOT‐10 mUC(NCT03785925)
ONCOS‐102 is an oncolytic adenovirus serotype 5 armed with a GM‐CSF transgene. Sequential ONCOS‐102 and pembrolizumab treatment in advanced anti‐PD1 refractory melanoma patients showed acceptable safety profile (most common ONCOS‐102 related adverse events were fevers, chills, and myalgias). ORR was 3 of 9 patients (RECIST 1.1). Part 2 of this pilot study is currently enrolling an additional 12 patients to receive 12 injections
of ONCOS‐102 with pembrolizumab.
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