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- Title
A multicenter, phase II trial of GC1118, a novel anti‐EGFR antibody, for recurrent glioblastoma patients with EGFR amplification.
- Authors
Choi, Seung Won; Jung, Hyun Ae; Cho, Hee‐Jin; Kim, Tae Min; Park, Chul‐Kee; Nam, Do‐Hyun; Lee, Se‐Hoon
- Abstract
Background: We evaluated the therapeutic efficacy of GC1118, a novel anti‐epidermal growth factor receptor (EGFR) monoclonal antibody, in recurrent glioblastoma (GBM) patients with EGFR amplification. Methods: This study was a multicenter, open‐label, single‐arm phase II trial. Recurrent GBM patients with EGFR amplification were eligible: EGFR amplification was determined using fluorescence in situ hybridization analysis when a sample had both the EGFR/CEP7 ratio of ≥2 and a tight cluster EGFR signal in ≥10% of recorded cells. GC1118 was administered intravenously at a dose of 4 mg/kg once weekly. The primary endpoint was the 6‐month progression‐free survival rate (PFS6). Next‐generation sequencing was performed to investigate the molecular biomarkers related to the response to GC1118. Results: Between April 2018 and December 2020, 21 patients were enrolled in the study and received GC1118 treatment. Eighteen patients were eligible for efficacy analysis. The PFS6 was 5.6% (95% confidence interval, 0.3%–25.8%, Wilson method). The median progression‐free survival was 1.7 months (range: 28 days–7.2 months) and median overall survival was 5.7 months (range: 2–22.0 months). GC1118 was well tolerated except skin toxicities. Skin rash was the most frequent adverse event and four patients experienced Grade 3 skin‐related toxicity. Genomic analysis revealed that the immune‐related signatures were upregulated in patients with tumor regression. Conclusion: This study did not meet the primary endpoint (PFS6); however, we found that immune signatures were significantly upregulated in the tumors with regression upon GC1118 therapy, which signifies the potential of immune‐mediated antitumor efficacy of GC1118.
- Subjects
EPIDERMAL growth factor receptors; FLUORESCENCE in situ hybridization; GLIOBLASTOMA multiforme; PROGRESSION-free survival; SURVIVAL rate
- Publication
Cancer Medicine, 2023, Vol 12, Issue 15, p15788
- ISSN
2045-7634
- Publication type
Article
- DOI
10.1002/cam4.6213