Japanese phase I study of GC33, a humanized antibody against glypican-3 for advanced hepatocellular carcinoma.
Bottom Line: The most common adverse events were decreased lymphocyte count, decreased natural killer cell count, increased C-reactive protein, and pyrexia.Grade 3 adverse events (increased blood pressure, decreased lymphocyte count, and decreased platelet count) were observed in two or more patients.Furthermore, three patients showed long-term stable disease of more than 5 months.
Affiliation: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.Show MeSH
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Mentions: The efficacy analysis population consisted of all 13 patients who were treated with GC33. There were no patients whose best overall response was complete or partial response. Seven out of 13 patients (54%) showed stable disease (SD) (cohort 1, two out of four patients; cohort 2, two out of three patients; cohort 3, three out of six patients), the others showed PD. Three patients who had SD had received treatment for more than 5 months before progress (Fig. 2) and had a high GPC3 IHC score by method 1 (IHC score ≥7), similar to the previous phase I study.(14) The median PFS for all patients was 2.1 months (1.6–3.5 months) (95% confidence interval). There was no significant difference in the best overall response or PFS among the three cohorts. Seven out of 11 patients (64%) evaluated showed a decrease in AFP (six patients with 20% reduction), and 11 out of 13 patients (85%) showed a decrease in DCP (six patients with 40% reduction) compared to their baseline levels (Fig. 3a,b). Moreover, computed tomography imaging showed shrinkage in one patient's lung metastasis, in whom AFP and DCP levels were decreased (Fig. 3c). Two out of 13 patients were excluded from the AFP figure as their baseline AFP level was <10 ng/mL and deemed to be within the normal range.
Affiliation: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.