%0 Journal Article
%T Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma.
%A Scheiner B
%A Roessler D
%A Phen S
%A Lim M
%A Pomej K
%A Pressiani T
%A Cammarota A
%A Fründt TW
%A von Felden J
%A Schulze K
%A Himmelsbach V
%A Finkelmeier F
%A Deibel A
%A Siebenhüner AR
%A Shmanko K
%A Radu P
%A Schwacha-Eipper B
%A Ebert MP
%A Teufel A
%A Djanani A
%A Hucke F
%A Balcar L
%A Philipp AB
%A Hsiehchen D
%A Venerito M
%A Sinner F
%A Trauner M
%A D'Alessio A
%A Fulgenzi CAM
%A Pinato DJ
%A Peck-Radosavljevic M
%A Dufour JF
%A Weinmann A
%A Kremer AE
%A Singal AG
%A De Toni EN
%A Rimassa L
%A Pinter M
%J JHEP Rep
%V 5
%N 1
%D Jan 2023
%M 36578451
%F 9.917
%R 10.1016/j.jhepr.2022.100620
%X <B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.