Peter Galle, MD, PhD, University Medical Center Mainz, Germany, discussed results from the CheckMate 9DW trial which identified nivolumab plus ipilimumab as a potential new first-line option for patients with previously untreated unresectable hepatocellular carcinoma. 

Transcript: 

Hi, I'm Peter Galle from Mainz University Medical Center in Germany. I had the privilege to present on behalf of my coauthors the first interim analysis of the IPI-NIVO, ipilimumab and nivolumab, trial in front-line in hepatocellular carcinoma, running against the investigator's choice either lenvatinib or sorafenib. 

Fortunately for our patients this is a positive trial, we do see an impact on median overall survival by about 3 months, resulting in more than 23 months median overall survival for the ipilimumab-nivolumab treated group. Also, we see landmark analysis at 2 and 3 years which are much in favor of the ipilimumab-nivolumab arm. We also saw very impressive objective responses, 36% versus 13%. And in those patients where responses occur, they are very durable, they last more than 30 months. 

We do have strong signs of efficacy and if you think about it, we do have an unmet medical need here. We have seen improvements over the years with the IMbrave150 trial and the HIMALAYA trial, they both were positive trials: the IMbrave150 trial showed 30% objective response but at the same time 30% objective response means 70% non-responding, defining the need for other systemic therapeutic options and we have them here. 

The toxicity of this combination, ipilimumab-nivolumab, was within our experience from the past. We do see some discontinuation (18%) because of treatment-related adverse events but there were no unexpected results. Toxicity was mainly coming from skin and liver: we saw rash, pruritus, and hepatitis-like features. 

In essence, a trial which clearly demonstrates a positive outcome, efficacy, and safety within previous observations. We believe that this trial and this combination, ipilimumab and nivolumab, in front-line for advanced stage hepatocellular carcinoma patients will be a new option added to what we already have.

Source: 

Galle P. Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC): First results from CheckMate 9DW. Presented at the ASCO Annual Meeting. May 31 – June 4, 2024; Chicago, IL. Abstract #LBA4008