Opdivo® (nivolumab) used alone or in combination with Yervoy® (ipilimumab) appears to extend progression-free survival in patients with advanced melanoma. These findings were presented at 2015 Annual Meeting of the American Society of Clinical Oncology (May 29–June 2, Chicago, Illinois) and published in the New England Journal of Medicine.

Standard treatment for advanced melanoma typically involves surgery to remove the cancer. Because many patients will experience a recurrence following treatment with surgery alone, doctors have been searching for an appropriate therapy to be administered after surgery to improve outcomes.

Both Opdivo and Yervoy have appeared promising in the treatment of advanced melanoma. These drugs are designed to help the immune system recognize and fight cancer. Opdivo belongs to a new class of medicines called PD-1 inhibitors, which block the protein PD-1. PD-1 inhibits certain types of immune responses. Yervoy, a type of drug know as a monoclonal antibody, targets a molecule known as CTLA4. CTLA4 is found on the surface of T cells (a type of immune cell) and is thought to inhibit immune responses. It’s thought that blocking PD-1 or CTLA4 or both may improve the immune system’s ability to fight cancer.

To determine whether Opdivo and Yervoy were more effective alone or in combination, researchers evaluated Opdivo alone, Opdivo plus Yervoy, and Yervoy alone in patients with advanced melanoma. The 945 patients included in the study hadn’t been previously treated. They were divided into treatment groups, where they received either Opdivo alone, Opdivo plus Yervoy, or Yervoy alone. The researchers were primarily looking at progression-free survival.

Patients who received the combination of Opdivo plus Yervoy had the longest progression-free survival—11.5 months. Those receiving Opdivo alone had the second longest progression-free survival—6.9 months—followed by Yervoy alone—2.9 months.

Opdivo plus Yervoy or Opdivo alone appeared most effective among patients whose tumors were positive for PD-1 (the protein Opvido is designed to block). Progression-free survival with the combination therapy and Opdivo alone among this group was 14 months. Patients with PD-1-negative tumors had the best progression-free survival with the combination therapy—11.2 months versus 5.3 months with Opvido alone.

While more effective, the combination of Opdivo and Yervoy caused more serious side effects than either drug alone. Among patients receiving the combination, 55% experience moderate to severe side effects, compare with 27% for those on Yervoy alone and 16% for those on Opvido alone.

Opdivo and Yervoy in combination or Opvido alone appeared active in the treatment of patients with metastatic melanoma that hadn’t been previously treated. When combined with Yervoy or used alone, Opvido extended progression-free survival longer than Yervoy alone.

Reference: Larkin J, Chiarion-Sileni V, Gonzalez R, et al.  Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. New England Journal of Medicine [early online publication]. May 31, 2015.

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