Clinical Trial Report: Opdivo (Nivolumab) for Liver Cancer
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
Given the recent increase in inquiries from liver cancer patients, this is a report on a clinical trial titled: "Phase I/II Safety and Antitumor Activity of Nivolumab in Patients with Advanced Hepatocellular Carcinoma (HCC): CA209-040." This study targeted liver cancer patients, including 11 with HCV, 11 with HBV, and 21 without infection. Among them, 17 patients continued treatment, while 30 discontinued (CR: 2, PD: 26, side effects: 1, DLT: 1). For the group without virus infection and the HCV group, a dosage of 3 mg/kg was used (see Figure 1).
Table 1 shows that Grade 3 or higher adverse events occurred in 9 patients (19%), primarily consisting of Grade 3 AST/ALT elevations.
As shown in Figure 2 (where * denotes CR), the response rate was 19% (including 2 CRs). Broken down by subgroup, the response rates were 14% for the non-infected group, 36% for the HCV group, and 10% for the HBV group.
Figure 3 shows the 9-month and 12-month survival rates, which were 70% (95% CI: 52-82) and 62% (95% CI: 42-76), respectively.
In conclusion, Opdivo (nivolumab) appears to be partially effective for patients with HBV and HCV. An expanded clinical trial using a 3 mg/kg dosage is currently underway.
Source:
- Sangro B, et al.: J Hepatol. 59(1):81-88, 2013 (LINK)
- Luis Paz-Ares, et al.: 2015 Annual Meeting of the American Society of Clinical Oncology®: abst #LBA109
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