Nivolumab Found Safe and Effective in Ovarian Cancer Phase II Trial

Nivolumab acts as an immunomodulator by blocking ligand activation of the programmed cell death 1 (PD-1) receptor on the surface of activated T-cells. If another molecule, called PD-L1 or PD-L2, binds to PD-1, the T-cell becomes inactive. This is one way that the body regulates the immune system, to avoid an overreaction.

Many cancer cells make PD-L1, which inhibits T-cells from attacking the tumor. Nivolumab blocks PD-L1 from binding to PD-1, allowing the T-cell to work. Nivolumab has been approved by the [US] Food and Drug Administration for treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs. In addition, it was approved for the treatment of squamous non-small-cell lung cancer.

To increase the usefulness of the drug, investigators at Kyoto University (Japan) assessed the safety and antitumor activity of nivolumab in patients with platinum-resistant ovarian cancer. In a Phase II clinical trial lasting three years they injected nivolumab into 20 patients with platinum-resistant ovarian cancer every two weeks up to a period of one year or until the disease progressed.

Results published in the December 1, 2015, issue of the Journal of Clinical Oncology revealed that most of the patients were able to complete the trial with a median overall survival of 20 months. The encouraging safety and clinical efficacy of nivolumab as determined in this study indicated the merit of additional large-scale investigations.

"As a result of this study outcome, medical institutions - especially in the US - have become enthusiastic about running clinical trials for ovarian cancer using nivolumab," said senior author Dr. Ikuo Konishi, professor of gynecology and obstetrics at Kyoto University. "We hope this treatment will become more accessible in Japan in the near future."

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Kyoto University