News Feature | June 27, 2014

Bristol-Myers Skin Cancer Drug Clinical Trial Succeeds

By Marcus Johnson

Bristol-Myers skin cancer drug nivolumab has met its primary end point at late-stage clinical trials, which has led the company to end the trial ahead of schedule. Bristol-Myers concluded that patients treated with the company’s nivolumab drug lived longer than patients who were treated with only chemotherapy. The researchers compared nivolumab with dacarbazine, which is used to treat skin cancer. Nivolumab was tested as a treatment for melanoma, which is considered to be the most deadly form of skin cancer. All patients in the study suffered from advanced melanoma.

Bristol-Myers declined to list specific results from the study. But with these positive results in hand, the company is preparing to file for an FDA approval for the drug as a NSCLC treatment.  Bristol-Myers has continued to test nivolumab in conjunction with Yervoy, another drug already approved for the treatment of melanoma. The company has stated that it is also continuing to test the drug against multiple tumor types in more than 35 studies in order to fully understand the drug’s other potential uses.

Michael Giordano, the head of the company’s oncology development, commented on the results of the study, saying it “represents the first well-controlled, randomized Phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit.”

Nivolumab is an immunotherapy, which means that the drug manipulates the body’s own immune system in order to fight against cancer. Immunotherapies are considered to be longer lasting than current cancer treatments, as cancer cells and mutate and become resistant to chemotherapy. With immunotherapy treatments, the body becomes better at identifying cancer cells and the chance of remission is curbed.

The National Cancer Institute estimates that every year, 76,100 people are diagnosed with melanoma, with 9,710 deaths due to the skin cancer.