Abstract 994P
Background
In the final analysis of pts with uHCC from the observational REFINE study (NCT03289273), treatment-emergent adverse events (TEAEs) were consistent with the global, phase 3 RESORCE trial ( Kim YJ, ILCA 2022 ). Median overall survival (OS) in the overall cohort was 13.2 months. Pts with PLT are typically excluded from phase 3 clinical trials in HCC, including RESORCE. Here, we present the final analysis of pts with PLT in REFINE.
Methods
REFINE is an international, prospective, multicenter study that enrolled pts with uHCC for whom the decision to treat with REG was made by their physician before enrollment, according to the local health authority approved label. The primary aim was safety, including incidence of TEAEs (MedDRA v25) and dose modifications due to TEAEs. Secondary endpoints included OS and duration of treatment (DoT).
Results
Of the 1005 evaluable pts, 25 (2%) had PLT (median age, 60 [range 40–69] years; 60% Asian, 96% male). Most pts had ALBI grade 1 (60%), Child-Pugh A status (64%), ECOG performance status 0–1 (80%), and received prior sorafenib (92%); while none received prior immunotherapy. Furthermore, the most common HCC etiology was hepatitis B (68% vs 37% in pts with no PLT). Transarterial chemoembolization was the most common additional prior non-systemic treatment in the PLT subgroup (56%). Median DoT was numerically longer in the PLT vs non-PLT subgroup (5.5 [range 0.6–16.8] vs 3.7 [range <0.1–38.9] months). The most common TEAEs in the PLT subgroup were hand–foot skin reaction (52%), diarrhea (32%), and fatigue (24%). There were no grade 5 drug-related TEAEs in the PLT subgroup. Drug-related TEAEs leading to dose modification or permanent discontinuation were comparable in the PLT and non-PLT subgroups (44% vs 37% and 12% vs 16%, respectively). Median OS from start of REG treatment was similar in the PLT (15.8 months; 95% CI 10.1, 25.4) and non-PLT (12.8 months; 95% CI 11.4, 14.6) subgroups, and with the overall cohort.
Conclusions
Final data from the REFINE study confirm the safety and effectiveness of REG in pts with uHCC and PLT, consistent with findings from the overall cohort.
Clinical trial identification
Editorial acknowledgement
Editorial assistance in the preparation of this abstract was provided by Open Health Scientific Communications, London UK, with financial support from Bayer.
Legal entity responsible for the study
The authors.
Funding
Bayer.
Disclosure
M. Pinter: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Bayer, Bristol Myers Squibb, Lilly, Eisai, Ipsen, MSD, Roche; Financial Interests, Personal, Speaker’s Bureau: Bayer, Bristol Myers Squibb, Eisai, Lilly, Roche. Y.J. Kim: Financial Interests, Institutional, Research Funding: BTG, Boston Scientific, AstraZeneca, Gilead Sciences, Samjin, BL&H, Bayer; Financial Interests, Personal, Speaker, Consultant, Advisor: Bayer, BMS, PharmaKing, Celltrion, Bukwang, Roche, AbbVie, Eisai, Boston Scientific, BMS, BTG, Bayer, MSD, Gilead, Novo Nordisk, Green Cross Cell, Boehringer Ingelheim. P. Merle: Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, AstraZeneca, MSD, Eisai, Bayer, Ipsen; Financial Interests, Institutional, Research Funding: Ipsen. R.S. Finn: Financial Interests, Personal, Speaker, Consultant, Advisor: Pfizer, Bayer, Novartis, Bristol Myers Squibb, Merck, Eisai, Lilly, Genentech/Roche, AstraZeneca, Exelixis, CStone Pharmaceuticals; Financial Interests, Institutional, Research Funding: Pfizer, Bayer, Novartis, Eisai, Lilly, Merck, Bristol Myers Squibb, Roche/Genentech; Financial Interests, Personal, Expert Testimony: Bayer. J. Khan: Financial Interests, Personal, Full or part-time Employment: Bayer. K. Ozgurdal: Financial Interests, Personal, Stocks or ownership: Bayer; Financial Interests, Personal, Full or part-time Employment: Bayer. All other authors have declared no conflicts of interest.
Resources from the same session
956P - Phase II study of adjuvant tislelizumab combined with interferon-α and active surveillance in hepatocellular carcinoma patients with microvascular invasion
Presenter: Yixiu Wang
Session: Poster session 18
957P - Interim report of Notable-HCC: A phase Ib study of neoadjuvant PD-1 with stereotactic body radiotherapy in patients with resectable hepatocellular carcinoma (HCC)
Presenter: Mingming Li
Session: Poster session 18
959P - Combination therapy of envafolimab and suvemcitug in patients with hepatocellular carcinoma (HCC): Results from a phase II clinical trial
Presenter: Lixia Ma
Session: Poster session 18
960P - Personalized circulating tumor DNA (ctDNA) monitoring for recurrence detection and treatment response assessment in hepatocellular carcinoma (HCC)
Presenter: Maen Abdelrahim
Session: Poster session 18
961P - Blood circulating Galectin-3 is a prognostic biomarker in hepatocellular carcinoma
Presenter: Shadi Chamseddine
Session: Poster session 18
962P - SBRT improves the efficacy of immuno-checkpoint inhibitors for hepatocellular carcinoma through the activation of IL-6/JAK1-STAT3/PD-L1 axis mediated by MBD3 degradation
Presenter: Weiwei Yan
Session: Poster session 18
963P - Discovery and validation of cfDNA methylation, AFP and ctDNA mutation for the early detection of hepatocellular carcinoma: A multicenter prospective study (ASCEND-Hep)
Presenter: Mingxin Pan
Session: Poster session 18
966P - Potential role of neuropilin-1 in the prognosis, development and risk of invasion in hepatocellular carcinoma patients
Presenter: Tania Payo-Serafín
Session: Poster session 18