Results of the Study of Tislelizumab in Unresectable HCC

Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center discusses the results of the phase 2 study (NCT03419897) of tislelizumab (BGB-A317) in patients with unresectable hepatocellular carcinoma (HCC).

According to Abou-Alfa, the response rate seen was independent of several indicators such as gender, stage, and performance status. The median overall survival for the entire study population was 13.2 months. For patients with 1 prior line of therapy it was 13.8 months and 12.4 months for those with more than 2 prior lines of therapy.

The agent was well tolerated, according to Abou-Alfa. Grade 3 fatigue and rash were limited. The duration of response has not been reached. A phase 3 trial is planned to compare tislelizumab to sorafenib (Nexavar) as a first-line treatment for HCC. 

0:08 | It's important here to know that the response rate was displayed among all different subgroup analyses independent of gender, performance, stage, etc. More importantly, though, this translated into an overall median survival of 13.2 months, and at the same time, is this was the spring further into 13.8 months for 1 prior line of therapy, and 12.4 months for more than equal to 2 lines of therapy.

1:24 | The adverse events were the standard that we would see in this line of therapy, and they were thankfully limited. And they were noted for the grade 3 fatigue 0.8% and rash at 0.4%. We're happy with the increased response of 13.3% as I mentioned, duration of response with a median that's not reached, but with a follow-up of up to 1 year and add to this we had a median overall survival of 13.2 months and we will look forward for the phase 3 trial as I mentioned, which is looking at tislelizumab versus for sorafenib comparison as first-line treatment for patients with advanced HCC.