Zachary Bessette

GI Oncology Now

Additional analyses from the CheckMate 9DW study shed further light on the clinical efficacy and safety of first-line ipilimumab plus nivolumab (ipi/nivo) for unresectable hepatocellular carcinoma (uHCC).The <a href="https://meetings.asco.org/abstracts-presentations/241145" target="_blank" rel="noopener">latest data</a>&mdash;which highlight efficacy by best overall response (BOR) subgroups, baseline characteristics, and additional safety analyses&mdash;were presented by Dr. Masatoshi Kudo and colleagues at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.In the phase III CheckMate 9DW study, a total of 668 patients with previously untreated uHCC who were not eligible for curative surgical or locoregional therapies and had a Child-Pugh score of 5 or 6 and an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 were randomized to receive nivo (1 mg/kg) plus ipi (3 mg/kg every 3 weeks for up to 4 cycles), then nivo (480 mg every 4 weeks) or len (8 mg or 12 mg once daily) or sor (400 mg twice daily) until disease progression or unacceptable toxicity occurred. Nivo was given for a maximum of 2 years.The primary endpoint of the study was overall survival (OS), and secondary endpoints included objective response rate (ORR) and duration of response (DOR).Previous readouts of the study showed that first-line ipi/nivo provided improved OS benefit compared with lenvatinib plus sorafenib (len/sor), as well as a higher ORR with durable responses and a manageable safety profile in patients with uHCC.Among the total patient population, 335 received ipi/nivo and 333 received len/sor. At a median follow-up of 35.2 months, the median OS was 23.7 months (95% CI, 18.8-29.4) and 20.6 months (95% CI, 17.5-22.5), respectively (hazard ratio [HR], 0.79; P=.018). Researchers also noted that the ORR was significantly higher with ipi/nivo than with len/sor (36% vs 13%; P&lt;.0001). Median DOR was 30.4 months versus 12.9 months, respectively.A survival benefit with ipi/nivo was observed across BOR subgroups at the 24-week landmark timepoint. Subgroup analyses showed ORR was higher with ipi/nivo across HCC etiologies and in patients with Barcelona Clinic Liver Cancer stage &le;B or C.&ldquo;These additional analyses from CheckMate 9DW demonstrate the efficacy and manageable safety of 1L [first-line] NIVO + IPI in uHCC and further support its use as a potential standard-of-care treatment option in this setting,&rdquo; study authors concluded.

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CheckMate 9DW Expanded Analyses: Ipi/Nivo Versus Len/Sor for Unresectable HCC

Additional analyses from the CheckMate 9DW study shed further light on the clinical efficacy and safety of ipi/nivo for uHCC.