Editor’s Note: In an oral presentation selected by the ESMO Asia Scientific Committee, Dr. David Tai (Singapore) presented updated subgroup analyses from the Phase III CheckMate 9DW study, examining the relationship between immune-mediated adverse events (IMAEs) and the efficacy of nivolumab plus ipilimumab (Nivo+Ipi), with additional safety data in Asian patients.
Background: CheckMate 9DW and Nivo+Ipi
CheckMate 9DW is a global, open-label Phase III trial comparing first-line Nivo+Ipi with lenvatinib or sorafenib in unresectable hepatocellular carcinoma (HCC). Previous results demonstrated significant improvements in overall survival (OS) and objective response rate (ORR) with a manageable safety profile, leading to first-line approval across multiple regions, including the US, EU, China, and Japan.
This analysis evaluated whether IMAE occurrence influenced treatment efficacy and assessed additional outcomes in Asian patients, who accounted for 280 of 668 randomized participants.
3-Month Landmark Analysis: IMAEs and Efficacy
A 3-month landmark analysis showed that Nivo+Ipi provided durable OS benefit and clinically meaningful ORR regardless of IMAE occurrence. Patients who experienced IMAEs demonstrated numerically superior outcomes, with a median OS of 32.6 months versus 23.6 months in those without IMAEs, and an ORR of 42% versus 29%, respectively.
When stratified by severity, median OS reached 35.1 months in patients with Grade ≥3 IMAEs compared with 30.0 months in those with Grade ≤2 events, suggesting a numerical association between IMAE development and enhanced efficacy.
IMAE Profile and Immune-Mediated Hepatitis in Asian Patients
Among 132 Asian patients treated with Nivo+Ipi, the incidence, timing, and severity of IMAEs were consistent with the overall population. Most events occurred within the first three months and were Grade 1–2, rarely leading to treatment discontinuation.
The incidence of any-grade immune-mediated hepatitis was 16%, comparable to the global rate of 19%. Median time to onset was 5.9 months, and following standard management, 86% of cases resolved with a median resolution time of 13.6 weeks, allowing most patients to continue therapy.
Conclusion and Outlook
Dr. Tai concluded that first-line Nivo+Ipi delivers durable OS benefit and clinically meaningful ORR in unresectable HCC, regardless of IMAE occurrence. Numerically higher OS and ORR were observed in patients who developed IMAEs.
The consistent safety profile and manageable immune-mediated hepatitis in Asian patients further support Nivo+Ipi as a global standard of care for unresectable HCC.
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