The others had disease progression. Grade 3 and 4 adverse reactions that occurred in more than 5% of patients were related to liver enzymes: 12% had increased AST, 10% had increased ALT, and 5% increased lipase. Notably, dose-limiting toxicity occurred in only one patient who had neither HBV nor HCV infection.

Response was evaluable in 39 patients, of whom 5% had a complete response (CR) and 14% had a partial response (PR) (Table).2


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Table: Best Overall Response to Nivolumab Among Evaluable Patients
Response (number of patients) No HBV/HCV (20 patients) HBV/HCV (19 patients) Total
Complete response 2 0 2
Partial response 0 6 6
Stable disease 12 6 18
Progressive disease 5 7 12

The duration of complete response was 14 to more than 17 months; partial response duration was less than 1 month to 8 or more months, and stable disease duration was 1.5 months to 17 or more months.

Overall survival at 6 months is 72%, according to Dr. El-Khoueiry. He added, “The response rate of 19% and the prolonged duration of response and stable disease are encouraging and offer potential promise” for patients with advanced HCC.

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Additionally, this study alleviates concerns about using immune checkpoint inhibitors in viral disease, as no specific safety signal emerged in the HBV/HCV.

Discussant Lawrence Fong, MD, of the University of California, San Francisco, concluded that this study provides evidence that for patients with advanced HCC and limited options, “nivolumab has clinical efficacy without significant toxicity,” and that “patients can achieve a durable response.”

References:

  1. Gao Q, Wang XY, Qiu SJ, et al. Overexpression of PD-L1 significantly associated with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma. Clin Cancer Res. 2009;15:971-979.
  2. El-Khoueiry AB, Melero I, Crocenzi TS, et al. Phase I/II safety and antitumor activity of nivolumab in patients with advanced hepatocellular carcinoma: CA209-040. J Clin Oncol. 2015;33(Suppl):Abstr LBA101. http://meetinglibrary.asco.org/content/146146-156. Accessed June 1, 2015.