A multicenter, phase 2 study of atezolizumab plus bevacizumab (atezo+bev) combination therapy in patients with unresectable hepatocellular carcinoma (HCC) and Child–Pugh class B cirrhosis: CHALLENGE trial final results.

• DOI: 10.1200/jco.2025.43.4_suppl.587
• Publication Date: 2025-01-27T14:32:44Z
• Authors: Masafumi Ikeda; Takeshi Terashima; Tatsuya Yamashita; Takuji Okusaka; Hiroshi Imaoka; Tomokazu Kawaoka; Satoshi Kobayashi; Sadahisa Ogasawara; Atsushi Hiraoka; Masahito Nakano; Fumio Nagashima; Rie Sugimoto; Michihisa Moriguchi; Yoshitaka Inaba; Satoru Shinoda; Makoto Ueno; Naoya Kato; Masatoshi Kudo; Junji Furuse; Hiroaki Nagano
• Keywords: Atezolizumab

587 Background: The Phase 2 CHALLENGE trial (jRCTs031210355) evaluated the safety and efficacy of atezo+bev combination therapy in patients with advanced HCC Child–Pugh class B cirrhosis. Results trial’s main analysis demonstrated that was well-tolerated. Here, we present final outcomes. Methods: This multicenter, open-label, single-arm, study enrolled a score 7 or 8 who had not received prior systemic therapy. Patients were administered atezolizumab 1200 mg plus bevacizumab 15 mg/kg every 3 weeks. primary endpoint frequency severe adverse events (SAEs). Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), time to progression (TTP), overall (OS), (AEs). Results: A total 31 between December 2021 April 2023. points 25 (80.6%) 6 (19.4%). Fourteen (45.2%) classified as having Barcelona Clinic Liver Cancer stage C. We set 30 eligible population for analysis. performed median follow-up duration 517days showed SAEs 30.0% (95% confidence interval [CI] 14.7–49.4%). ORRs according RECIST 1.1 modified 40.0% 46.7%, respectively. Median PFS, TTP, OS 240 days CI: 176–526 days), 470 256–576 Frequent Grade ≥3 blood bilirubin increased (n=3), proteinuria hypoalbuminemia (n=2), hypertension (n=2). liver-related AEs occurred (23.3%), including (n=3) esophageal varices hemorrhage immune-related – these mucositis oral (n=1) malaise (n=1). mean (±standard deviation) at start treatment 7.2±0.4, 7.0±1.0, 7.2±0.9, 7.6±1.7 third fifth cycles withdrawal study, Conclusions: Atezo+bev well-tolerated demonstrable anti-tumor effects unresectable Additional studies are warranted confirm results this patient group. Clinical information: jRCTs031210355.