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Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma

Background & Aims - We investigated the efficacy and safety of immune checkpoint inhibitor (ICI) rechallenge in patients with hepatocellular carcinoma (HCC) who received ICI-based therapies in a previous systemic line. - Methods - In this international, retrospective multicenter study, patients...

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Main Authors: Scheiner, Bernhard (Author) , Roessler, Daniel (Author) , Phen, Samuel (Author) , Lim, Mir (Author) , Pomej, Katharina (Author) , Pressiani, Tiziana (Author) , Cammarota, Antonella (Author) , Fründt, Thorben Wilhelm (Author) , Felden, Johann von (Author) , Schulze, Kornelius (Author) , Himmelsbach, Vera (Author) , Finkelmeier, Fabian (Author) , Deibel, Rudolf Ansgar (Author) , Siebenhüner, Alexander (Author) , Shmanko, Kateryna (Author) , Radu, Pompilia (Author) , Schwacha-Eipper, Birgit (Author) , Ebert, Matthias (Author) , Teufel, Andreas (Author) , Djanani, Angela (Author) , Hucke, Florian (Author) , Balcar, Lorenz (Author) , Philipp, Alexander B. (Author) , Hsiehchen, David (Author) , Venerito, Marino (Author) , Sinner, Friedrich (Author) , Trauner, Michael (Author) , D'Alessio, Antonio (Author) , Fulgenzi, Claudia A. M. (Author) , Pinato, David J. (Author) , Peck-Radosavljevic, Markus (Author) , Dufour, Jean-François (Author) , Weinmann, Arndt (Author) , Kremer, Andreas (Author) , Singal, Amit G. (Author) , Toni, Enrico de (Author) , Rimassa, Lorenza (Author) , Pinter, Matthias (Author)
Format: Article (Journal)
Language:English
Published: January 2023
In: JHEP reports
Year: 2023, Volume: 5, Issue: 1
ISSN:2589-5559
DOI:10.1016/j.jhepr.2022.100620
Online Access:Resolving-System, kostenfrei: https://dx.doi.org/10.1016/j.jhepr.2022.100620
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Author Notes:Bernhard Scheiner, Daniel Roessler, Samuel Phen, Mir Lim, Katharina Pomej, Tiziana Pressiani, Antonella Cammarota, Thorben W. Fründt, Johann von Felden, Kornelius Schulze, Vera Himmelsbach, Fabian Finkelmeier, Ansgar Deibel, Alexander R. Siebenhüner, Kateryna Shmanko, Pompilia Radu, Birgit Schwacha-Eipper, Matthias P. Ebert, Andreas Teufel, Angela Djanani, Florian Hucke, Lorenz Balcar, Alexander B. Philipp, David Hsiehchen, Marino Venerito, Friedrich Sinner, Michael Trauner, Antonio D'Alessio, Claudia A. M. Fulgenzi, David J. Pinato, Markus Peck-Radosavljevic, Jean-François Dufour, Arndt Weinmann, Andreas E. Kremer, Amit G. Singal, Enrico N. De Toni, Lorenza Rimassa, Matthias Pinter
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Summary:Background & Aims - We investigated the efficacy and safety of immune checkpoint inhibitor (ICI) rechallenge in patients with hepatocellular carcinoma (HCC) who received ICI-based therapies in a previous systemic line. - Methods - In this international, retrospective multicenter study, patients with HCC who received at least two lines of ICI-based therapies (ICI-1, ICI-2) at 14 institutions were eligible. The main outcomes included best overall response and treatment-related adverse events. - Results - Of 994 ICI-treated patients screened, a total of 58 patients (male, n = 41; 71%) with a mean age of 65.0±9.0 years were included. Median systemic treatment lines of ICI-1 and ICI-2 were 1 (range, 1-4) and 3 (range, 2-9), respectively. ICI-based therapies used at ICI-1 and ICI-2 included ICI alone (ICI-1, n = 26, 45%; ICI-2, n = 4, 7%), dual ICI regimens (n = 1, 2%; n = 12, 21%), or ICI combined with targeted therapies/anti-VEGF (n = 31, 53%; n = 42, 72%). Most patients discontinued ICI-1 due to progression (n = 52, 90%). Objective response rate was 22% at ICI-1 and 26% at ICI-2. Responses at ICI-2 were also seen in patients who had progressive disease as best overall response at ICI-1 (n = 11/21; 52%). Median time-to-progression at ICI-1 and ICI-2 was 5.4 (95% CI 3.0-7.7) months and 5.2 (95% CI 3.3-7.0) months, respectively. Treatment-related adverse events of grade 3-4 at ICI-1 and ICI-2 were observed in 9 (16%) and 10 (17%) patients, respectively. - Conclusions - ICI rechallenge was safe and resulted in a treatment benefit in a meaningful proportion of patients with HCC. These data provide a rationale for investigating ICI-based regimens in patients who progressed on first-line immunotherapy in prospective trials. - Impact and implications - Therapeutic sequencing after first-line immune checkpoint inhibitor (ICI)-based therapy for advanced hepatocellular carcinoma (HCC) remains a challenge as no available second-line treatment options have been studied in immunotherapy-pretreated patients. Particularly, the role of ICI rechallenge in patients with HCC is unclear, as data from prospective trials are lacking. We investigated the efficacy and safety of ICI-based regimens in patients with HCC pretreated with immunotherapy in a retrospective, international, multicenter study. Our data provide the rationale for prospective trials investigating the role of ICI-based regimens in patients who have progressed on first-line immunotherapy.
Item Description:Online verfügbar: 27. Oktober 2022, Artikelversion: 2. Januar 2023
Physical Description:Online Resource
ISSN:2589-5559
DOI:10.1016/j.jhepr.2022.100620

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