Key clinical point: In systemic therapy-naive patients with advanced hepatocellular carcinoma (HCC), pembrolizumab monotherapy demonstrates promising antitumor efficacy and survival outcomes, with a safety profile similar to that of second-line pembrolizumab in advanced HCC.
Major finding: After a 27-month median follow-up, the objective response rate was 16% (95% CI 7%-29%). The median progression-free and overall survival were 4 (95% CI 2-8) and 17 (95% CI 8-23) months, respectively. Treatment-related adverse events of grade ≥ 3 were observed in 16% of patients.
Study details: The data are derived from cohort 2 of the multicenter, phase 2 KEYNOTE-224 trial that included 51 systemic therapy-naive adult patients with advanced HCC who received 200 mg pembrolizumab every 3 weeks for ≤2 years.
Disclosures: This study was sponsored by Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., NJ. Some authors declared receiving grants, personal fees, or other support from various sources, including 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;28(12):2547–2554 (Jun 13). Doi: 10.1158/1078-0432.CCR-21-3807