KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Clinical Trial Results
Advanced Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Clinical Findings from KEYNOTE-224
Objective Response Rate and Duration of Response
Objective Response Rate (ORR)a
In 104 patients with advanced HCC who were previously treated with sorafenibResponse
Response
Duration of Response (DOR)
KEYTRUDA (n=18/104) |
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% patients with responses lasting ≥6 months89% |
% patients with responses lasting ≥12 months56% |
Study Design for KEYNOTE-224
Study Design Details
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Study Arm
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Patient Characteristics (N=104):
- Median age: 68 (67% were aged ≥65 years)
- Ethnicity: White 81%, Asian 14%
- Gender: Male 83%
- HBV seropositive: 21%
- HCV seropositive: 25%
- HBV and HCV seropositiveb: 9%
- ECOG PS 1: 39%
- ECOG PS 0: 61%
- Child-Pugh Class A5: 72%
- Child-Pugh Class A6: 22%
- Child-Pugh Class B7: 5%
- Child-Pugh Class B8: 1%
- Extrahepatic disease: 64%
- Vascular invasion: 17%
- Extrahepatic disease with vascular invasion: 9%
- AFP levels >400 µg/L: 38%
- Prior treatment history: Sorafenibc: 100%