Cemiplimab, a human monoclonal anti-PD-1, in patients (pts) with advanced or metastatic hepatocellular carcinoma (HCC): Data from an expansion cohort in a phase I study

Abstract

Background: For pts with unresectable HCC, systemic therapy options are limited. Sorafenib is approved in the US and Europe for HCC treatment. For pts who progress on sorafenib, regorafenib and nivolumab are approved as second-line therapy. Cemiplimab (REGN2810) has demonstrated encouraging efficacy and safety profile in a Phase 1 dose escalation study in pts with advanced malignancies (NCT02383212). We present results of the Phase 1 HCC expansion cohort. Methods: HCC pts who were not candidates for surgery and had progressed on, could not tolerate, or refused first-line systemic therapy received cemiplimab 3 mg/kg Q2W for up to 48 weeks. The main objectives were to evaluate the safety, tolerability, and antitumour activity of cemiplimab. Results: As of 1 Sept, 2017, 26 pts were enrolled (25 M/1 F), median (range) age was 65 (40-78) years; 24 pts (92.3%) had 1 prior systemic therapy; ECOG performance status was 1 in 19 pts (73.1%), 0 in 6 (23.1%) and missing in 1. Median duration of follow-up was 7.2 (range: 1.8-15.5) months. By investigator assessment, 5 pts (19.2%) had partial response, 14 (53.8%) had stable disease, 6 (23.1%) had progressive disease and 1 was not evaluable. Median progression-free survival was 3.7 months (95% CI: 2.3-9.