Immunotherapy nivolumab: safe and effective in advanced liver cancer29 May 2015
New clinical data of a phase 1/2 study revealed that an immunotherapy drug called nivolumab can be considered safe and effective in treating patients with advanced liver cancer.
Based on the results of the phase 1 part of the study, eight (19%) of the 42 evaluable patients responded to the anti-PD-1 antibody with tumor reduction beyond 30%. More importantly, the responses have been durable and surpassed 12 months in four patients. Nivolumab is marketed as Opdivo and acts by inducing the immune system to attack the tumor.
Patients with advanced liver cancer are in particular need of new treatments as there is currently only one FDA-approved systemic treatment for advanced liver cancer, the multi-targeted tyrosine kinase inhibitor, sorafenib.
“Objective tumor shrinkage beyond 30%”
In particular, 75% of the patients enrolled on the study had previously received systemic therapy, including 68% who had received sorafenib. Nivolumab was given intravenously every two weeks for up to two years.
The report issued after careful analysis of the results showed that:
- The overall response rate was 19%, with 8 patients experiencing objective tumor shrinkage beyond 30%, and 2 having complete remissions.
- The responses were durable, with 50% lasting beyond 12 months as most patients continued on treatment.
- Tumors stabilized (tumor growth was stalled) in 48% of patients, with the longest case lasting beyond 17 months.
- Nivolumab was safe and well tolerated, even in patients with ongoing hepatitis B or C infections. Specifically, there have not been any safety concerns related to flares of hepatitis B infection or worsening viral infection.
“A new class of drugs for patients with liver cancer”
The majority of the side effects were mild to moderate in nature with abnormal liver enzymes, rash, and elevation of amylase and lipase being the most common; the abnormal liver enzymes and elevated amylase and lipase were not accompanied by any significant clinical symptoms.
As El-Khoueiry, MD, an associate professor of clinical medicine and phase 1 program director at the University of Southern California Norris Comprehensive Cancer Center in Los Angeles, CA. commented: “while we have to verify this early signal in larger studies, this is one of the first signs that immunotherapy with immune checkpoint inhibitors will have a role in the treatment of liver cancer “ adding that “the findings from this early trial open the door to a new class of drugs for patients with liver cancer”.Source: eCancer News