New Hepatocellular Carcinoma Treatment Approved by FDA

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Patients with hepatocellular carcinoma can look forward to the FDA accelerated approval of nivolumab (Opdivo) after prior sorafenib (Nexavar) treatment.

Hepatocellular carcinoma is a common form of liver cancer that cannot be cured in advanced stages. This type of cancer has been linked to hepatitis B, hepatitis C, cirrhosis, heavy drinking, obesity and diabetes.

Symptoms of hepatocellular carcinoma include pain and discomfort in the belly areas, swelling in the belly, loss of appetite, feelings of fullness, weight loss, fatigue, nausea, chalky movements, and dark urine. While this cancer may be incurable in later stages, there are treatment options available to patients to slow the progression.

This recent and exciting approval was made after 154 patients in a phase I/II CheckMate-040 trial recorded an overall response rate of 18.2% for patients who had use sorafenib treatment prior (based on myRECIST criteria). In addition to this promising percentage, 3.2% of patients recorded a complete response rate.

In the full CheckMate-040 trial, there were 262 patients enrolled from November 26, 2012, to August 8, 2016 who suffered from advanced HCC. 48 of these patients were put into a dose-escalation phase and the remaining 214 patients were put into the dose-expansion phase. A majority of the patients in both phases were already exposed to and had prior treatment with sorafenib.

Patients in the escalation phase received 0.1 to 10 mg/kg of IV nivolumab every 2 weeks while those in the expansion phase were administered nivolumab at 3 mg/kg every 2 weeks.

Responses from these two groups were seen early and successful. At the 2017 ASCO Annual Meeting, findings showed that in the expansion phase group, the mRECIST overall response rate by BICR was 19%. The disease control rate was also a promising 56%. 56% of patients who had not used sorafenib prior showed responses within 3 months of initiation and 64% of patients who had used sorafenib prior did as well.

To learn more about the details of this research, check out OncLive here.

This information is all incredibly hopeful to the hepatocellular carcinoma community. President of Bristol-Myers Squibb, Chris Boerner states, “We are proud to bring the potential for clinically meaningful responses with Immuno-Oncology therapy to these advanced-stage HCC patients, who have had limited treatment options for years.”

But it’s not over yet. Full approval of the new treatment nivolumab depends on the results of a bigger trial. Thus, a phase III randomized trial of nivolumab versus sorafenib is in the works with the goal of enrolling 276 patients. Researchers are hopeful that the completion date of this concluding trial will be this month, October 2018.


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