CHICAGO–The adverse event profile of nivolumab with or without ipilimumab in patients with glioblastoma was consistent with studies in other tumors and 6 month overall survival data is encouraging, a study presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL, has shown.
For the study, researchers enrolled 20 patients with first recurrence of primary glioblastoma multiforme and no prior bevacizumab treatment. Patients were randomly assigned 1:1 to receive nivolumab 3 mg/kg every 2 weeks or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks followed by nivolumab 3 mg/kg every 2 weeks.
Results showed that drug-related adverse events experienced by three or more patients included fatigue and nausea with nivolumab and fatigue, diarrhea, AST/ALT elevation, lipase elevation, vomiting, amylase elevation, headache, hyperthyroidism, nausea, and macropapular rash with the combination.
Researchers found that all adverse events associated with nivolumab treatment alone were grade 1 or 2, while 80% of those treated with nivolumab plus ipilimumab experienced grade 3 or 4 adverse events. Four patients discontinued combination treatment due to treatment-related adverse events prior to completing four doses of treatment. No patients died as a result of treatment.
In regard to efficacy, the overall survival rate at 6 months was 75% (70% in the nivolumab arm and 80% in the nivolumab plus ipilimumab arm). At 9 months, the overall survival rate was 60% in both arms.
In an interview with Cancer Therapy Advisor, John H. Sampson, MD, PhD, lead author and chief of the Division of Neurosurgery at Duke University in Durham, NC, said, “It’s early on. We certainly see evidence of response in some patients, which is rare for patients with glioblastoma…We saw less toxicity with nivolumab alone that with the combination, and we have encouraging preliminary overall survival statistics at 6 and 9 months.”
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More cohorts in this trial are planned to evaluate nivolumab plus radiotherapy with or without temozolomide in patients with newly diagnosed glioblastoma.
Due to the encouraging findings, the phase III portion of CHECKMATE-143 has been initiated to assess the efficacy of nivolumab 3 mg/kg monotherapy with bevacizumab in patients with recurrent glioblastoma multiforme.
- Sampson JH, Vlahovic G, Sahebjam S, et al. Preliminary safety and activity of nivolumab and its combination with ipilimumab in recurrent glioblastoma (GBM): CHECKMATE-143. J Clin Oncol. 2015:33;(suppl; abstr 3010).