IMbrave150: The First Successful, Phase III Trial of a Cancer Immunotherapy Combination vs Sorafenib in 1L Unresectable or mHCC 1

Phase III, multicenter, international, open-label, randomized trial in patients with previously untreated locally advanced unresectable and/or metastatic HCC 1,3

Patients received IV infusions of TECENTRIQ 1200 mg q3w and Avastin 15 mg/kg q3w on Day 1 of each 21-day cycle. Sorafenib was administered orally, 400 mg twice daily, on Days 1 to 21 of each 21-day cycle. Randomization was stratified by geographic region (Asia excluding Japan vs rest of world), macrovascular invasion and/or extrahepatic spread (presence vs absence), baseline AFP (<400 vs ≥400 ng/mL), and ECOG performance status (0 vs 1). The randomization stratification factors were applied to all stratified efficacy analyses except ECOG performance.

Coprimary endpoints 1*
  • Overall survival
  • Progression-free survival
Key secondary endpoints 1,3
  • Overall response rate
  • Duration of response

1L=first line; AFP=alpha-fetoprotein; ECOG=Eastern Cooperative Oncology Group; HCC mRECIST=hepatocellular carcinoma modified Response Evaluation Criteria In Solid Tumors; IRF=independent review facility; ITT=intent to treat; IV=intravenous; mHCC=metastatic hepatocellular carcinoma; q3w=every 3 weeks; RECIST=Response Evaluation Criteria In Solid Tumors.
*In ITT population.
Assessed by IRF per RECIST v1.1.
Assessed by IRF per RECIST v1.1 and HCC mRECIST.

Baseline characteristics in patients with unresectable or mHCC 3

BCLC=Barcelona clinic liver cancer; EHS=extrahepatic spread; HBV=hepatitis B virus; HCV=hepatitis C virus; IQR=interquartile range; MVI=macrovascular invasion; PS=performance status; TACE=transarterial chemoembolization.
§Japan is included in rest of world.

In IMbrave150, approximately 75% of patients had EHS and/or MVI 1