Key clinical point: Pembrolizumab monotherapy showed favorable efficacy in systemic therapy-naive patients with advanced hepatocellular carcinoma (aHCC), with no new safety signals in addition to those observed for pembrolizumab in aHCC in a second-line setting.
Major finding: The objective response rate was 16% (95% CI 7%-29%), and the median duration of response was 16 months. The median progression-free and overall survival were 4 (95% CI 2-8) and 17 (95% CI 8-23) months, respectively. Only 16% of patients experienced grade ≥3 treatment-related adverse events.
Study details: Findings are from the phase 2 KEYNOTE-224 trial including 51 adult, systemic therapy-naive patients with aHCC who received 200 mg pembrolizumab intravenously every 3 weeks for up to 35 cycles.
Disclosures: The study was sponsored by Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., USA. Some authors reported being advisory board members, consultants, or advisors or receiving research grants, speaker honoraria, or travel and accommodation expenses from various sources, including MSD. The other authors are employees and stock owners of MSD.
Source: Verset G et al. Pembrolizumab monotherapy for previously untreated advanced hepatocellular carcinoma: Data from the open-label, phase II KEYNOTE-224 trial. Clin Cancer Res. 2022 (Apr 14). Doi: 10.1158/1078-0432.CCR-21-3807