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CHECKMATE: Experienced HCC patients respond well to Opdivo
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AMSTERDAM — Patients with HCC who failed prior therapy experienced encouraging survival outcomes and response rates with Opdivo, according to data presented at the International Liver Congress.
Jorg Trojan, MD, of Goethe University in Frankfurt, Germany, noted that Nexavar (sorafenib, Bayer & Onyx Pharmaceuticals) is currently the only treatment option for HCC. “Most patients progress or have intolerability,” he said. “Thereafter, there is no approved treatment option.”
The current phase 1/2 multi-cohort study included 262 patients. There were 48 patients in a dose escalation arm who received 0.1 mg/kg to 10 mg/kg of Opdivo (nivolumab, Bristol-Myers Squibb), which included 11 sorafenib-naive patients and 37 sorafenib-experienced patients. A dose expansion arm included 214 patients who received 3 mg/kg nivolumab, and of whom 69 patients were sorafenib-naive.
Trojan focused his presentation on 145 patients with sorafenib experience in the dose expansion arm. This group comprised 30 patients with HCV, 43 patients with HBV and 72 patients uninfected with viral hepatitis.
The overall response rate in this group was 14.5%. Overall response rates for the subgroups were 20% for patients with HCV, 14% for those with HBV and 12.5% for the uninfected patients.
Trojan said that the disease control rate among these patients was nearly 56%. The time to response was 2.1 months for the HCV group, 2 months for HBV, and 4 months for the uninfected. Therapy was ongoing in these groups, with 27% of patients with HCV, 19% of those with HBV, and 18% of uninfected patients still receiving care.
“We observed substantial decreases in tumor volume in all three experienced subgroups,” Trojan said. “There was also a decrease in tumor burden over time.”
The overall survival rate in this group was 16.7%. This endpoint was not reached in the HCV or HBV cohorts.
Regarding the dose escalation group, the overall response rate was 9.1% for sorafenib-naive patients and 18.9% for those with experience, for an overall response rate of 16.7%. The overall response rate in the entire dose expansion group was 16.8%, with 21.7% of sorafenib-naive patients in this group responding.
The regimen demonstrated an expected side effect profile. “There was a slight increase in grade 3 to 4 transaminases, but these events were mild and reversible with the established algorithm,” Trojan said. “Otherwise, there were no new signals.”
Trojan described nivolumab as an anti-PD-1 blocking antibody that has shown the capacity to restore T-cell mediated anti-tumor activity. Previous data from CHECKMATE 040 were published recently.
“In sorafenib-experienced patients with or without chronic viral hepatitis, nivolumab demonstrated long-term survival and durable objective responses with extended follow up,” Trojan concluded. “There was limited antiviral activity in HCV- and HBV-infected patients.” – by Rob Volansky
Reference:
Trojan J, et al. Abstract GS-010. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.
Disclosure: Trojan reports being on the advisory board or speakers bureau of Bristol-Myers Squibb.