Phase 2 study supports first-line pembrolizumab in advanced HCC

Patients receiving pembrolizumab monotherapy for previously untreated advanced hepatocellular carcinoma (HCC) in a phase 2 trial delivered durable responses. Results supported a favourable risk-to-benefit ratio for pembrolizumab in this population.

Dr Jean-Luc van Laethem (Hôpital Erasme–Université Libre de Bruxelles, Belgium) presented the data from cohort 2 of the single-arm, multicentre phase 2 KEYNOTE-224 trial (NCT02702414), in which patients with treatment-naïve HCC (n=51; mean age 68 years; 86% male) received pembrolizumab every 3 weeks intravenously for 35 cycles, followed by a potential re-treatment phase of 1 year [1]. The primary endpoint of the trial was objective response rate (ORR) with key secondary endpoints being duration of response (DOR), disease control rate (DCR), time to progression (TTP), progression-free survival (PFS), overall survival (OS), and safety.

With a mean follow-up of 21 months (range 17-23 months) at this presentation, the ORR was 16%, all of which represented partial responses. In addition, 21 patients (41%) had stable disease. The median DOR was not reached (range 3 to >20 months), with 70% of patients estimated as having a response duration of ≥12 months, across all patient subgroups analysed. Furthermore, median TTP was 4 months with a rate at 12 months of 31%. The 12-month PFS rate was 24% (median of 4 months). OS was a median of 17 months, with a 12-month rate of 58%.

Overall, pembrolizumab was well tolerated in this patient population, with safety signals entirely consistent with the known profile. The phase 3 study results have to be awaited to conform the efficacy.

1. Van Laethem JL, et al. Pembrolizumab (pembro) monotherapy for previously untreated advanced hepatocellular carcinoma (HCC): Phase II KEYNOTE-224 study. ASCO Gastrointestinal Cancers Symposium 2021, 15-17 January. Abstract 297.

 

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Posted on 12 March, 20214 September, 2023