Nivolumab has demonstrated encouraging safety and clinical efficacy data in patients with platinum-resistant ovarian cancer, a new study published online ahead of print in the Journal of Clinical Oncology.1
For the phase 2 study, researchers enrolled 20 women with platinum-resistant ovarian cancer and assigned them to receive nivolumab 1 or 3 mg/kg intravenously every 2 weeks.
Results showed that the best overall response was 15% with two patients achieving a durable complete response, which occurred in the 3 mg/kg cohort. Median progression-free survival was 3.5 months (95% CI: 1.7, 3.9) and the median overall survival was 20.0 months (95% CI: 7.0, not reached) at the time of study termination.
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In regard to safety, 40% of the 20 patients experienced grade 3 or 4 treatment-related adverse events. Two patients experienced severe adverse events.
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The findings indicate that large-scale investigations should be conducted to further evaluate the efficacy and safety of nivolumab in patients with platinum-resistant ovarian cancer.
Nivolumab is already approved by the U.S. Food and Drug Administration (FDA) for the treatment of unresectable or metastatic melanoma and metastatic squamous non-small cell lung cancer.
Reference
- Hamanishi J, Mandai M, Ikeda T, et al. Safety and antitumor activity of anti-PD-1 antibody, nivolumab, in patients with platinum-resistant ovarian cancer [published online ahead of print September 8, 2015]. J Clin Oncol. doi: 10.1200/JCO.2015.62.3397.
