Hepatocellular Carcinoma: Recent Approval of Nivolumab


Ghassan Abou-Alfa, MD: Among the different checkpoint inhibitors that I’m alluding to in one way or another, the first that really made it to an FDA approval is nivolumab. Nivolumab is an anti-PD-1 agent that, if anything, was approved based on phase II data, which is something that came out of left field for us in HCC. It was an approval based on a phase II trial, and this was based on the fact that the trial that looked into nivolumab in patients with advanced HCC who have failed prior therapy—for example, sorafenib or what have we—led to an impactful response rate. That’s really where the story was.

The response rate on average of the first-time takers or patients who have progressed on prior sorafenib, or any other therapy, come in altogether at about 20%; 1 in 5 patients respond to therapy, but this is old news in HCC. I would say that the agency, wisely and appropriately, did provide an approval for nivolumab based on those data with the understanding, though, that there was an oncoming trial of nivolumab in the first-line setting versus sorafenib called CheckMate-459. If it is to be positive, then this will allow nivolumab to get full approval.

Checkpoint inhibitors, or immunotherapy, are a subject in all circles of our lives. In other words, it’s not surprising to all of us that patients will come in and say, “What about immunotherapy?” As such, there is so much anticipation and so much excitement about the subject, and understandably so because of the great results that we’re having with it. For that reason, technically every patient could be eligible for that therapy. Nonetheless, the expectation is that ultimately, despite that excitement, we have to first go by the rules and regulations. Who is eligible for that therapy? Secondly, of course, who really can’t tolerate that therapy?

In regard to the first aspect, please do remember that checkpoint inhibitors are not yet approved as a first-line treatment. Patients should have been receiving prior therapy like tyrosine kinase inhibitors to be allowed to get nivolumab, which is the sole checkpoint inhibitor that’s approved at this point in time.

On the other hand, even in that setup, if there is a certain concern about the immune aspects that the patient has in their system that could probably cause certain concern about giving nivolumab or any other checkpoint inhibitors, this has to be kept in mind. Only as an example, patients with active hepatitis B that is not necessarily under treatment or who come along with hepatitis C—and that’s really creating a rather highly inflamed situation in the liver—might be somebody who must be treated for that purpose before you would consider checkpoint inhibitors for them.

Transcript Edited for Clarity

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