Phase III randomized study of second line ADI-peg 20 (A) plus best supportive care versus placebo (P) plus best supportive care in patients (pts) with advanced hepatocellular carcinoma (HCC).

4017 Background: Arginine (Ar) depletion is a putative target in HCC, which lacks the citrulline (Ci) to Ar repleting enzyme argininosuccinate synthetase. A is an Ar degrading enzyme cloned from M. hominis and produced in E. coli and conjugated with polyethylene glycol. Methods: Pts with histologically proven advanced HCC and Child-Pugh (CP) up to B7 who failed or were intolerant to prior systemic therapy, were 2:1 randomized to A 18 mg/m2vs P...