The CheckMate-040 phase II dose escalation/expansion trial showed an objective response to nivolumab monotherapy in 20% of HCC patients, with a median duration of response of 9.9 months. 53 In the phase III CheckMate-459 trial, which compared nivolumab against sorafenib in Child-Pugh A patients with advanced HCC, the nivolumab arm trended towards better OS; however, this difference did not reach statistical significance (16.4 vs 14.7 months, p=0.075). 54 Nonetheless, the safety profile of nivolumab was more favorable than sorafenib, with >50% reduction in grade-3 or -4 treatment-emergent adverse events, making nivolumab monotherapy a potential therapeutic option when TKIs are contraindicated.
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