Clinical Trial Report: Opdivo (Nivolumab) for Liver Cancer

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:

1. Sangro B, et al.: J Hepatol. 59(1):81-88, 2013 (LINK)
2. Luis Paz-Ares, et al.: 2015 Annual Meeting of the American Society of Clinical Oncology®: abst #LBA109

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