Bruno Sangro, MD, PhD, professor of medicine and director of the Liver Unit at Clinica Universidad de Navarra, discusses the updated findings from the phase 3 CheckMate-459 trial (NCT02576509), which evaluated the use of nivolumab (Opdivo) and sorafenib (Nexavar) in the treatment of patients with advanced hepatocellular carcinoma (HCC).

The CheckMate-459 study compared the clinical efficacy and safety of nivolumab with sorafenib as first-line therapy in patients with advanced HCC. Results on prolonged survival follow-up were presented during the 

, says Sangro. Overall survival (OS) is a meaningful end point for any clinical trial in the advanced setting because it reflects the effect on the overall population, explains Sangro.

The updated findings showed that, as time goes on, there is an increase in the separation of the survival curves. Therefore, even if the median OS remains the same as in a previous report (16.4 months for nivolumab and 14.8 months for sorafenib, P= 0.052), the rate of longer-term survival is better in the nivolumab arm, says Sangro. At 33 months, patients in the nivolumab arm experienced a median OS survival rate of 29% versus 21% in the sorafenib arm. This is very prolonged follow-up providing a better understanding of how the impact of a good response to nivolumab offers the possibility to achieve long-term survival, explains Sangro.

This occurs despite the fact that more patients in the sorafenib arm (47%) received a second systemic therapy after nivolumab. A significant proportion of patients received a PD-1 or PD-L1 inhibitor following sorafenib, which potentially impacted the results that were observed in the sorafenib arm, concludes Sangro.

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Bruno Sangro, MD, PhD, discusses the updated findings from the phase 3 CheckMate-459 trial, which evaluated the use of nivolumab and sorafenib in the treatment of patients with advanced hepatocellular carcinoma.

Dr. Sangro on Updated Findings From the CheckMate-459 Trial in Advanced HCC

Bruno Sangro, MD, PhD head of Hepatology Unit, Internal Medicine Department, Clínica Universidad de Navarra, discusses the efficacy of nivolumab (Opdivo) in patients with hepatocellular carcinoma (HCC). 

Usually in phase Ib/II trials, efficacy is not observed. However, in this trial investigating nivolumab, there was clinically relevant anti-tumor activity, explains Sangro.  

According to Sangro, the response rate was between 15% to 20%, the median duration of response was 17 months, and a portion of patients had prolonged stable disease. 

Articles

Bruno Sangro, MD, PhD, head of Hepatology Unit, Internal Medicine Department, Clinica Universidad de Navarra, discusses the efficacy of nivolumab (Opdivo) in patients with hepatocellular carcinoma (HCC).

Dr. Sangro on the Efficacy of Nivolumab in HCC

Bruno Sangro, MD, PhD, head of Hepatology Unit, Internal Medicine Department, Clinica Universidad de Navarra, discusses the safety profile of nivolumab (Opdivo) in advanced hepatocellular carcinoma (HCC).

In the CheckMate-040 trial, the PD-1 immune checkpoint inhibitor nivolumab was evaluated in patients with advanced HCC. This was the first time any PD-1 inhibitor was tested in this population, says Sangro.

Nivolumab was found to have a very similar profile to its application in other tumor types, showing very few adverse events. This was found in patients without viral infections as well as patients who have hepatitis B and hepatitis C.

Bruno Sangro, MD, PhD

Articles

Dr. Sangro on Updated Findings From the CheckMate-459 Trial in Advanced HCC

Dr. Sangro on the Efficacy of Nivolumab in HCC

Dr. Sangro Discusses Safety Profile of Nivolumab in HCC