TRACON Pharmaceuticals presents data from TRC105, Nexavar study at ASCO
TRACON Pharmaceuticals announced that "positive" clinical data from its ongoing Phase 1b/2 study of TRC105 and Nexavar in patients with advanced hepatocellular carcinoma, or HCC, were presented in a poster presentation at the ASCO 2019 Gastrointestinal Cancers Symposium. Data from the ongoing open-label, non-randomized study were presented. Confirmed partial response by RECIST 1.1 occurred in 3 of 15 evaluable patients and a reduction of 50% or greater in alpha fetoprotein, or AFP, concentration occurred in 8 of 16 evaluable patients. Reduction in AFP, a tumor marker expressed in patients with HCC, in early treatment may help predict a favorable response to treatment. Adverse events expected of each drug did not increase in frequency or severity when TRC105 and sorafenib were administered concurrently. TRC105 trough concentrations were lower in HCC patients compared with prior TRC105 studies in other tumor types, and weekly dosing at the recommended Phase 2 dose of TRC105 of 10 mg/kg, rather than every other week dosing, was required to exceed target concentrations consistently. This may reflect increased target mediated clearance in HCC patients via fibrotic/cirrhotic liver disease. Anti-drug antibody was observed more frequently in patients with HCC compared with prior studies of TRC105 in other tumor types and may have influenced pharmacokinetics in individual patients.