BMS' Cancer Drug Nivolumab Shows Promising Results In Trial

Bristol-Myers Squibb’s experimental drug Nivolumab may boost survival of patients with advanced melanoma, according to an early phase trial conducted at John Hopkins Kimmel Cancer Center and 11 other institutions.

Patients who were involved in the trial had experienced disease progression after receiving previous systemic and sometimes multiple treatments. Those who responded to nivolumab survived for an average of 16.8 months after starting treatment. 62 percent of patients survived after one year of treatment and 43 percent survived after two years. Average survival among the patients whose tumor shrank was two years.

Study lead-author Suzanne Topalian, professor of surgery and oncology, and director of the melanoma program at Johns Hopkins, said “The results seen here are remarkable for these patients with treatment-resistant, advanced metastatic melanoma, who had limited life expectancies when they joined the trial.”

107 people with advanced melanoma received the intravenously administered medicine in an outpatient clinic every two weeks. Data suggest that some patients can remain on treatment safely for up to two years. The highest response rate was observed in 41 percent of patients who received 3mg per kg, the dose now being tested in Phase III trials. The patients given the dose survived an average of 20.3 months after starting treatment.

Results of the study were published in the Journal of Clinical Oncology. The experimental therapy is immune-based and designed to block a specific pathway that shields tumor cells from immune system components that have the potential to fight the disease. Two proteins are included in the pathway, namely programmed death-1 (PD-1) and programmed death ligand-1 (PD-L1). Once the two are joined, a biochemical shield is formed protecting tumor cells from being recognized and destroyed by the body’s immune system.

The drug is currently being tested in three larger, Phase III trials for treatment of melanoma compared to an existing standard therapy.