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

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Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma. / Scheiner, Bernhard; Roessler, Daniel; Phen, Samuel; Lim, Mir; Pomej, Katharina; Pressiani, Tiziana; Cammarota, Antonella; Fründt, Thorben W; von Felden, Johann; Schulze, Kornelius; Himmelsbach, Vera; Finkelmeier, Fabian; Deibel, Ansgar; Siebenhüner, Alexander R; Shmanko, Kateryna; Radu, Pompilia; Schwacha-Eipper, Birgit; Ebert, Matthias P; Teufel, Andreas; Djanani, Angela; Hucke, Florian; Balcar, Lorenz; Philipp, Alexander B; Hsiehchen, David; Venerito, Marino; Sinner, Friedrich; Trauner, Michael; D'Alessio, Antonio; Fulgenzi, Claudia A M; Pinato, David J; Peck-Radosavljevic, Markus; Dufour, Jean-François; Weinmann, Arndt; Kremer, Andreas E; Singal, Amit G; De Toni, Enrico N; Rimassa, Lorenza; Pinter, Matthias.

In: JHEP REP, Vol. 5, No. 1, 100620, 01.2023.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Scheiner, B, Roessler, D, Phen, S, Lim, M, Pomej, K, Pressiani, T, Cammarota, A, Fründt, TW, von Felden, J, Schulze, K, Himmelsbach, V, Finkelmeier, F, Deibel, A, Siebenhüner, AR, Shmanko, K, Radu, P, Schwacha-Eipper, B, Ebert, MP, Teufel, A, Djanani, A, Hucke, F, Balcar, L, Philipp, AB, Hsiehchen, D, Venerito, M, Sinner, F, Trauner, M, D'Alessio, A, Fulgenzi, CAM, Pinato, DJ, Peck-Radosavljevic, M, Dufour, J-F, Weinmann, A, Kremer, AE, Singal, AG, De Toni, EN, Rimassa, L & Pinter, M 2023, 'Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma', JHEP REP, vol. 5, no. 1, 100620. https://doi.org/10.1016/j.jhepr.2022.100620

APA

Scheiner, B., Roessler, D., Phen, S., Lim, M., Pomej, K., Pressiani, T., Cammarota, A., Fründt, T. W., von Felden, J., Schulze, K., Himmelsbach, V., Finkelmeier, F., Deibel, A., Siebenhüner, A. R., Shmanko, K., Radu, P., Schwacha-Eipper, B., Ebert, M. P., Teufel, A., ... Pinter, M. (2023). Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma. JHEP REP, 5(1), [100620]. https://doi.org/10.1016/j.jhepr.2022.100620

Vancouver

Scheiner B, Roessler D, Phen S, Lim M, Pomej K, Pressiani T et al. Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma. JHEP REP. 2023 Jan;5(1). 100620. https://doi.org/10.1016/j.jhepr.2022.100620

Bibtex

@article{28f1a5d12dd242399ceb053136c91ae9,
title = "Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma",
abstract = "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.",
author = "Bernhard Scheiner and Daniel Roessler and Samuel Phen and Mir Lim and Katharina Pomej and Tiziana Pressiani and Antonella Cammarota and Fr{\"u}ndt, {Thorben W} and {von Felden}, Johann and Kornelius Schulze and Vera Himmelsbach and Fabian Finkelmeier and Ansgar Deibel and Siebenh{\"u}ner, {Alexander R} and Kateryna Shmanko and Pompilia Radu and Birgit Schwacha-Eipper and Ebert, {Matthias P} and Andreas Teufel and Angela Djanani and Florian Hucke and Lorenz Balcar and Philipp, {Alexander B} and David Hsiehchen and Marino Venerito and Friedrich Sinner and Michael Trauner and Antonio D'Alessio and Fulgenzi, {Claudia A M} and Pinato, {David J} and Markus Peck-Radosavljevic and Jean-Fran{\c c}ois Dufour and Arndt Weinmann and Kremer, {Andreas E} and Singal, {Amit G} and {De Toni}, {Enrico N} and Lorenza Rimassa and Matthias Pinter",
note = "{\textcopyright} 2022 The Author(s).",
year = "2023",
month = jan,
doi = "10.1016/j.jhepr.2022.100620",
language = "English",
volume = "5",
journal = "JHEP REP",
issn = "2589-5559",
publisher = "Elsevier",
number = "1",

}

RIS

TY - JOUR

T1 - Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma

AU - Scheiner, Bernhard

AU - Roessler, Daniel

AU - Phen, Samuel

AU - Lim, Mir

AU - Pomej, Katharina

AU - Pressiani, Tiziana

AU - Cammarota, Antonella

AU - Fründt, Thorben W

AU - von Felden, Johann

AU - Schulze, Kornelius

AU - Himmelsbach, Vera

AU - Finkelmeier, Fabian

AU - Deibel, Ansgar

AU - Siebenhüner, Alexander R

AU - Shmanko, Kateryna

AU - Radu, Pompilia

AU - Schwacha-Eipper, Birgit

AU - Ebert, Matthias P

AU - Teufel, Andreas

AU - Djanani, Angela

AU - Hucke, Florian

AU - Balcar, Lorenz

AU - Philipp, Alexander B

AU - Hsiehchen, David

AU - Venerito, Marino

AU - Sinner, Friedrich

AU - Trauner, Michael

AU - D'Alessio, Antonio

AU - Fulgenzi, Claudia A M

AU - Pinato, David J

AU - Peck-Radosavljevic, Markus

AU - Dufour, Jean-François

AU - Weinmann, Arndt

AU - Kremer, Andreas E

AU - Singal, Amit G

AU - De Toni, Enrico N

AU - Rimassa, Lorenza

AU - Pinter, Matthias

N1 - © 2022 The Author(s).

PY - 2023/1

Y1 - 2023/1

N2 - 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.

AB - 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.

U2 - 10.1016/j.jhepr.2022.100620

DO - 10.1016/j.jhepr.2022.100620

M3 - SCORING: Journal article

C2 - 36578451

VL - 5

JO - JHEP REP

JF - JHEP REP

SN - 2589-5559

IS - 1

M1 - 100620

ER -