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ESMO Asia 2025 | CheckMate 9DW: nivolumab and ipilimumab outcomes by IMAEs in HCC

Changhoon Yoo, MD, PhD, Asan Medical Center, Seoul, South Korea, discusses efficacy outcomes of nivolumab plus ipilimumab according to the occurrence of immune-mediated adverse events (IMAEs) in patients with unresectable hepatocellular carcinoma (HCC) enrolled in the CheckMate 9DW trial (NCT04039607). Durable clinical benefit irrespective of immune events were recorded, where immune-mediated toxicities in Asian populations were generally manageable. This interview took place at 2025 European Society for Medical Oncology (ESMO) Asia Congress in Singapore, Singapore.

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Transcript

In this, yeah, actually, in this Checkmate 9DW subgroup analysis, the Asian efficacy data was not presented. It’s there that the efficacy outcomes per immune-mediated adverse events occurrence was presented. So this year in hepatology, the Himalaya trial also reported very similar analysis. It is that the immune-mediated adverse events were associated with the better survival outcomes with the CTLA-4 and the PD-L1 combination therapy...

In this, yeah, actually, in this Checkmate 9DW subgroup analysis, the Asian efficacy data was not presented. It’s there that the efficacy outcomes per immune-mediated adverse events occurrence was presented. So this year in hepatology, the Himalaya trial also reported very similar analysis. It is that the immune-mediated adverse events were associated with the better survival outcomes with the CTLA-4 and the PD-L1 combination therapy. So in this, in this Checkmate 9DW subgroup analysis, this is kind of the very similar, the analysis showed very similar analysis results. And in this study, the subgroup analysis was done per occurrence of any kind of immune-mediated adverse events. And this was associated with better overall survival. But we have to remind that even those patients without the immune-mediated adverse events, their survival outcome was better than the TKI monotherapy. So we believe that this kind of toxicity, immune-mediated toxicity, may be related to better survival outcomes in the dual ICI therapy. And additionally, in this Checkmate 9DW subgroup analysis, there was a safety analysis between the Asian and the global patient population. There was no difference in terms of the frequency of the grade 3 to 4 immune-mediated adverse events and grade 3 to 4 hepatitis events. It’s quite similar. But there’s a bit of numerical difference in terms of receiving high-dose steroid patient population. So 18% in the Asian subgroup and 29% in the global patient population. So 11% less. Less of the Asian subgroup received the high-dose steroid. So, yeah, that is the results of the Checkmate 9DW subgroup analysis presented at this ASMO Asia.

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