Study demonstrates drug's effectiveness for treating metastatic melanoma
Patients with metastatic cancer who are treated with ipilimumab experience improved survival, according to a study published in the New England Journal of Medicine.
For the study, led by Andrew Pecora, MD, FACP, CPE, chairman and executive administrative director, John Theurer Cancer Center, researchers focused on 676 patients with stage III or IV (metastatic) melanoma who had been previously treated unsuccessfully with another cancer drug. The patients were randomly assigned to one of three treatment groups: ipilimumab plus an inactive version of gp 100, a cancer vaccine; ipilimumab plus gp 100; and gp 100 plus ipilimumab placebo. The patients were administered treatments once every 3 weeks, for a total of four treatments.
According to the press release announcing the findings, ipilimumab is the first drug shown in randomized, placebo-controlled trials to improve survival in stage IV melanoma. Researchers reported that patients who received ipilimumab, alone and in combination with gp 100, lived on average about 10 months compared to 6.4 months for those who received only gp 100. After 2 years, approximately 23% of those who received ipilimumab were alive compared to 14% of those who did not receive the drug. Furthermore, 10 to 15% of those who received ipilimumab suffered immune system attacks, and seven of the 540 patients who received the drug died from the attacks.
The results of the study have led the FDA to grant priority review status to the approval of ipilimumab as treatment for metastatic melanoma.
“This study, and the FDA's decision, provides new hope for people with this devastating cancer,” said Dr. Pecora. “We are proud to have played a role in helping move another promising cancer treatment closer to the market.”