The addition of mapatumumab to sorafenib did not improve time to progression, progression-free survival, overall survival, or objective response in patients with advanced hepatocellular carcinoma (HCC), a study published online ahead of print in the journal Annals of Oncology has shown.1
Mapatumumab is a human agonistic monoclonal antibody that targets tumor necrosis factor-related apoptosis-inducing ligand receptor. Researchers sought to evaluate the safety and efficacy of the immunotherapy in combination with sorafenib for advanced HCC.
For the double-blind, placebo-controlled, phase 2 trial, researchers enrolled 101 patients with advanced HCC and randomly assigned them 1:1 to receive sorafenib 400 mg twice daily and either placebo or mapatumumab 30 mg/kg on day 1 of each 21-day cycle.
Results showed that median time to radiologic progression was 5.6 months with placebo compared with 4.1 months with mapatumumab (HR, 1.192; 90% CI: 0-1.737). There was also no significant improvement in other efficacy endpoints between the 2 treatment arms.
Furthermore, subgroup analyses did not demonstrate a time to progression benefit from mapatumumab in any subgroup.
In terms of safety, the frequency of reported adverse events and serious adverse events was comparable between the placebo and mapatumumab arms.
“Based on these results, further development of the combination of mapatumumab and sorafenib in HCC is not planned,” the authors conclude.
- Ciuleanu T, Bazin I, Lungulescu D, et al. A randomized, double-blind, placebo-controlled phase II study to assess the efficacy and safety of mapatumumab with sorafenib in patients with advanced hepatocellular carcinoma [published online ahead of print January 22, 2016]. Ann Oncol. doi:10.1093/annonc/mdw004.