by Dr. C.H.Weaver M.D. updated 6/2019
Results from the CheckMate 040 clinical trial have been recently reported and found that Opdivo (nivolumab), an immuno-oncology drug which acts by modulating the immune system, produces durable responses with long-term survival rates in patients with liver cancer, regardless of whether or not patients were infected with Hepatitis B or C.
These study results were presented at The International Liver Congress™ 2017 in Amsterdam, and showed that the overall response rate was 19.3% in patients previously treated with Nexaver (sorafenib), and responses were ongoing in 71% of patients. Overall ~ 60% of these advanced patients were alive greater than one year from beginning Opdivo.
Liver cancer, or hepatocellular carcinoma (HCC), is the second most common cause of cancer-related deaths worldwide.1,2 The prognosis for patients with advanced liver cancer is poor,2 and the multikinase inhibitor, Nexaver, has been the only approved treatment, until the recent approval of Stirvaga.3,4
Opdivo is a programmed-death-1 (PD-1) immune checkpoint inhibitor that is designed to use the body’s own immune system to help restore the anti-cancer immune response.5 It restores T-cell-mediated anti-cancer activity so that the T cells recognize and attack cancer cells.5
The CheckMate 040 clinical trial was designed to evaluate Opdivo in patients with advanced liver cancer who were previously treated with Nexavar and were not suitable for surgery.6 All 145 patients were treated with intravenous Opdivo every 2 weeks until the cancer progressed or side effects became intolerable. In addition to the overall response rate of 19%, average overall survival was 16.7 months. Responses to Opdivo occurred regardless of programmed death-1 (PD-1) ligand expression on cancer cells.
- 1 World Health Organization. Cancer. Available from: http://www.who.int/mediacentre/factsheets/fs297/en/. Last accessed: April 2017.
- 2 World Health Organization. GLOBOCAN 2012: Estimated cancer incidence, mortality and prevalence worldwide in 2012. Available from: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Last accessed: April 2017.
- 3 EASL-EORTC Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2012;56:908-943.
- 5 Melero I, et al. Nivolumab dose escalation and expansion in patients with advanced hepatocellular carcinoma (HCC): The CheckMate 040 study. J Clin Oncol. 2017;35 (suppl 4S: abstract 226.
- 6 ClinicalTrials.gov. NCT Identifier: NCT01658878. A study to evaluate the effectiveness, safety and tolerability of nivolumab and the combination nivolumab plus ipilimumab in patients with advanced liver cancer (CheckMate 040). Available from: https://clinicaltrials.gov/show/NCT01658878. Last accessed: April 2017.