Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Nivolumab + Ipilimumab Shows 'Robust' Benefit in HCC Patients

Key clinical point: The combination of nivolumab and ipilimumab provided a robust clinical benefit and had manageable hepatic adverse events.

Major finding: Response rates ranged from 31% to 32% in the three arms, while one particular dosing regimen had a median overall survival of 22.8 months.

Study details: Results from the CheckMate 040 trial, including 148 patients with advanced hepatocellular carcinoma previously treated with sorafenib randomized to one of three different dosing regimens with nivolumab plus ipilimumab.

Disclosures: The study was supported by Bristol-Myers Squibb and ONO Pharmaceutical. The presenter reported disclosures related to Adaptimmune, AstraZeneca, Bayer, Bristol-Myers Squibb, BTG, Merck, Onxeo, Sirtex Medical, Terumo, H3 Biomedicine, Ipsen, Lilly, Exelixis, Roche, and Ipsen.


Sangro B et al. The Liver Meeting 2019, Abstract 200.


Hepatocellular carcinoma (HCC) is a challenging cancer to treat for several reasons, including frequent underlying liver damage. Nivolumab results in improved outcomes in HCC. The addition of ipilimumab to nivolumab is associated with an improvement in outcomes, compared with nivolumab alone in other cancers. Sangro et al. evaluated the combination of nivolumab plus ipilimumab in HCC and reported an approximate doubling in response rates, compared with historical nivolumab-only controls, while overall survival varied depending on the treatment schedule. Hepatic toxicity was thought to be acceptable. Future studies will likely be conducted to verify these results in a more definitive way.—Mark A. Klein, MD