{
  "abstract": "Introduction Patients with unresectable hepatocellular carcinoma have a poor prognosis, and treatments with long-term benefits are needed. At a median follow-up of 4 years, we report updated efficacy and safety results of the CheckMate 9DW trial assessing nivolumab plus ipilimumab versus lenvatinib or sorafenib for unresectable hepatocellular carcinoma in the first-line setting.Methods Adults with previously untreated histologically confirmed advanced HCC, either ineligible for or having progressed after curative surgical/locoregional therapies, ≥1 measurable untreated lesion per RECIST v1.1, Child–Pugh score 5 or 6, and ECOG performance status 0 or 1 were included. Pts were randomized 1:1 to receive NIVO 1 mg/kg + IPI 3 mg/kg Q3W (up to 4 cycles) followed by NIVO 480 mg Q4W or investigator’s choice of SOR 400 mg BID or LEN 8 mg or 12 mg QD until disease progression or unacceptable toxicity. NIVO was given for a maximum of 2 years. The primary endpoint was OS; secondary endpoints included ORR and duration of response (DOR) per blinded independent central review (BICR).Results A total of 668 pts were randomized to NIVO + IPI (n = 335) or LEN/SOR (n = 333); among 325 pts treated in the LEN/SOR arm, 275 (85%) received LEN. After a median (range) follow-up of 52.5 (44.0–66.1) months, NIVO + IPI continued to show OS benefit vs LEN/SOR (HR, 0.78; 95% CI, 0.65–0.93), with higher 48-month OS rates (31% vs 18%; table 1). ORR was higher with NIVO + IPI vs LEN/SOR (36% vs 13%), with higher complete response rates (8% vs 2%, respectively) and durable responses (median DOR, 34.3 vs 12.9 months, respectively; table 1). A summary of treatment-related adverse events (TRAEs) is shown in the table 1.Conclusions After 4 years of follow-up, 1L NIVO + IPI continued to show sustained efficacy benefit vs LEN/SOR in unresectable HCC and manageable safety with no new concerns. These results continue to support NIVO + IPI as a standard-of-care treatment in these patients.©2026 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and presented at the 2026 ASCO Gastrointestinal Cancers Symposium. All rights reserved.Abstract P51 Table 1EfficacyNIVO + IPI(n = 335)LEN/SOR(n = 333)Median OS (95% CI), mo23.7 (18.8–29.4)20.6 (17.7–22.5) HR (95% CI)0.78 (0.65–0.93)48-mo OS rate (95% CI), %31 (26–36)18 (14–23)ORR,a n (%); 95% CI122 (36); 31–4244 (13); 10–17Median DORa,b (95% CI), mo34.3 (22.6–47.7)12.9 (10.2–33.9)Safety, n (%)(n = 332)(n = 325)Any-grade/grade 3–4 TRAEs277 (83)/136 (41)297 (91)/138 (42)Any-grade/grade 3–4 TRAEs leading to discontinuation59 (18)/44 (13)34 (10)/21 (6)aPer BICR. bIn responders only.",
  "authors": [
    {
      "affiliations": [
        "University Medical Center, Mainz, Germany"
      ],
      "name": "Peter Galle"
    },
    {
      "affiliations": [
        "Clinica Universidad de Navarra and CIBEREHD, Spain"
      ],
      "name": "Bruno Sangro"
    },
    {
      "affiliations": [
        "Univ. Grenoble Alpes, CHU Grenoble Alpes, Institute for Advanced Biosciences, CNRS UMR -INSERM U, Grenoble, France"
      ],
      "name": "Thomas Decaens"
    },
    {
      "affiliations": [
        "Kindai University Hospital, Osaka, Japan"
      ],
      "name": "Masatoshi Kudo"
    },
    {
      "affiliations": [
        "Nanjing Tianyinshan Hospital of China Pharmaceutical University, Nanjing, China"
      ],
      "name": "Shukui Qin"
    },
    {
      "affiliations": [
        "Instituto do Câncer do Estado de São Paulo, ICESP, São Paulo, Brazil"
      ],
      "name": "Leonardo Da Fonseca"
    },
    {
      "affiliations": [
        "Cross Cancer Institute, Edmonton, Canada"
      ],
      "name": "Hatim Karachiwala"
    },
    {
      "affiliations": [
        "National Cancer Center and Myongji Hospital, Goyang, Republic of Korea"
      ],
      "name": "Joong-Won Park"
    },
    {
      "affiliations": [
        "Auckland City Hospital, Auckland, New Zealand"
      ],
      "name": "Edward Gane"
    },
    {
      "affiliations": [
        "Medical University of Vienna, Vienna, Austria"
      ],
      "name": "Matthias Pinter"
    },
    {
      "affiliations": [
        "National Cancer Centre, Singapore, Republic of Singapore"
      ],
      "name": "David Tai"
    },
    {
      "affiliations": [
        "IRCCS Humanitas Research Hospital- Humanitas Cancer Center, Milan, Italy"
      ],
      "name": "Armando Santoro"
    },
    {
      "affiliations": [
        "Bradford Hill Centro de Investigación Clínica, Recoleta, Chile"
      ],
      "name": "Gonzalo Pizarro"
    },
    {
      "affiliations": [
        "Centrul de Oncologie Sf. Nectarie, Craiova, Romania"
      ],
      "name": "Michael Schenker"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, USA"
      ],
      "name": "Qi Wang"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, USA"
      ],
      "name": "Maria Jesus Jimenez Exposito"
    },
    {
      "affiliations": [
        "Center of Cancer Medicine and University Department of Medicine, The University of Hong Kong"
      ],
      "name": "Thomas Yau"
    }
  ],
  "title": "P51 Nivolumab plus ipilimumab vs lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (HCC): 4-year follow-up of CheckMate 9DW",
  "uid": "ec744b18-3559-5475-ae2d-faaa0f81481a"
}