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Pembrolizumab Granted Approval for Hepatocellular Carcinoma

Patients with advanced hepatocellular carcinoma (HCC) who have progressed on sorafenib can now take FDA-approved pembrolizumab (Keytrudaâ, Merck & Co., Inc.).

Approval was based on KEYNOTE 224 (NCT02702414), a single-arm, multicenter trial which enrolled 104 patients with HCC. For trial eligibility, patients were required to have disease progression on or after using sorafenib, measurable disease, and Child-Pugh Class A liver impairment. Patients were administered 200 mg of pembrolizumab as an intravenous infusion over 30 minutes every three weeks for 24 months or until disease progression or unacceptable toxicity.

Pembrolizumab produced an overall response rate of 17% and a complete response in 1% of patients. 46 patients had stable disease, and 34 patients had progressive disease. The duration of response ranged from 3.1 to 16.7 months. The majority of patients (89%) had response durations of 6 months or longer, and over half (56%) of those patients had response durations of 12 months or longer.

Adverse effects of pembrolizumab occurred in 73% of patients; however, only 15% were serious cases. Grade 3 treatment-related side effects were reported in 25 of the 104 patients; the most common side effect was increased aspartate aminotransferase concentration, which occurred in seven patients. There were also incidences of grade 3/4 ascites (8%) and immune-mediated hepatitis (2.9%). There was one reported case of grade 4 hyperbilirubinaemia.

These results indicate that pembrolizumab is a potential treatment option for patients with advanced HCC. Pembrolizumab was shown to be effective and tolerable as a monotherapy treatment for patients who used sorafenib as first-line treatment.

According to KEYNOTE's lead investigator, Andrew X. Zhu, MD, PhD, Director of Liver Cancer Research at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, "Hepatocellular carcinoma is the most common type of liver cancer in adults, and while we have seen recent therapeutic advancements, there are still limited treatment options for advanced recurrent disease. Today's approval of Keytruda is important, as it provides a new treatment option for patients with hepatocellular carcinoma who have been previously treated with sorafenib."

Pembrolizumab was granted accelerated approval based on its efficacy. Further studies will be conducted as required.

For More Information

Clinicaltrials.gov (2018). Study of pembrolizumab (MK-3475) as monotherapy in participants with advanced hepatocellular carcinoma (MK-3475-224/KEYNOTE-224). NLM identifier: NCT02702414.

Zhu A, Finn R, Edeline J, et al (2018). Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomized, open-label phase 2 trial. Lancet Oncol, 19(7):940-952. DOI:10.1016/S1470-2045(18)30351-6. 

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