Kudo, Masatoshi, Finn, Richard S, Edeline, Julien, Cattan, Stephane, Ogasawara, Sadahisa, Palmer, Daniel H 
ORCID: 0000-0002-7147-5703, Verslype, Chris, Zagonel, Vittorina, Fartoux, Laetitia, Vogel, Arndt et al (show 11 more authors)
(2022)
Updated efficacy and safety of KEYNOTE-224: a phase II study of pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib.
EUROPEAN JOURNAL OF CANCER, 167.
pp. 1-12.
Abstract
<h4>Objective</h4>Pembrolizumab, a PD-1 inhibitor, demonstrated anti-tumour activity and tolerability in patients treated with sorafenib and with advanced hepatocellular carcinoma in KEYNOTE-224. Longer-term efficacy and safety after ∼2.5 years of additional follow-up are reported.<h4>Patients and methods</h4>Adults with confirmed hepatocellular carcinoma who experienced progression after or intolerance to sorafenib treatment received pembrolizumab 200 mg every 3 weeks for ≤35 cycles or until confirmed progression, unacceptable toxicity, withdrawal of consent or investigator decision. The primary end-point was objective response rate assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumours v1.1. The secondary end-points included duration of response, disease control rate, time to progression, progression-free survival, overall survival and adverse events.<h4>Results</h4>Efficacy and safety were assessed in 104 patients. The median time from first dose to data cutoff was 45.1 months (range, 41.3-49.3). Objective response rate was 18.3% (95% CI: 11.4-27.1), and median duration of response was 21.0 months (range, 3.1 to 39.5+). Disease control rate was 61.5%, and median time to progression was 4.8 months (95% CI: 3.9-7.0). Median progression-free survival was 4.9 months (95% CI: 3.5-6.7) and median overall survival was 13.2 months (95% CI: 9.7-15.3). Of 104 patients, 76 (73.1%) patients reported treatment-related adverse events; most were low grade in severity (grade 3-4, n = 26 [25.0%]; grade 5, n = 1 [1.0%]). Immune-mediated hepatitis occurred in 3 patients (all grade 3). No viral-induced hepatitis flares occurred.<h4>Conclusions</h4>After ∼2.5 years of additional follow-up, pembrolizumab continued to provide durable anti-tumour activity and no new safety concerns were identified.<h4>Clinicaltrials</h4><h4>Gov identifier</h4>NCT02702414.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Pembrolizumab, Anti-PD-1, Advanced hepatocellular carcinoma, Long-term treatment |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 24 Mar 2023 15:02 |
| Last Modified: | 24 Mar 2023 15:02 |
| DOI: | 10.1016/j.ejca.2022.02.009 |
| Open Access URL: | https://doi.org/10.1016/j.ejca.2022.02.009 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3169239 |
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