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In the context of Pembrolizumab & Hepatocellular Carcinoma (HCC), Pembrolizumab has had an FDA accelerated approval for advanced/unresectable Pembrolizumab & Hepatocellular Carcinoma (HCC) in patients previously treated with sorafenib. It was approved as second‑line monotherapy based largely on KEYNOTE‑224, although subsequent phase 3 data (KEYNOTE‑240) did not meet all prespecified statistical thresholds (4, 5, 6, 7)
Pembrolizumab alone resulted in an ORR of 17% among sorafenib-experienced …