Bristol-Myers Squibb Company (NYSE: BMY) announced positive results from a Phase 3 randomized, double blind study of ipilimumab which demonstrated that overall survival (OS) was significantly extended in patients with previously-treated metastatic melanoma who received ipilimumab.
The results were statistically significant for patients receiving ipilimumab alone or ipilimumab in combination with a gp100 peptide vaccine when compared to those patients who received the control therapy of gp100 alone.
44 to 46 percent of patients treated with ipilimumab were alive at one year compared to 25 percent of patients treated with the control arm. At two years, 22 to 24 percent of patients treated with ipilimumab were alive compared to 14 percent of patients treated with the control arm.
As in other studies of ipilimumab, the most common side effects reported in the study were immune-related and based on the mechanism of action. These immune-related adverse events were sometimes severe and life-threatening, and most often affected the gastrointestinal, skin, liver, or endocrine systems.
The data were published in the New England Journal of Medicine and presented at the 46th Annual Meeting of the American Society of Clinical Oncology.
“Metastatic melanoma is one of the deadliest forms of cancer with no approved options for pre-treated patients,” said Steven J. O’Day, M.D., Chief of Research and Director of the Melanoma Program at The Angeles Clinic and Research Institute, California, and presenter of the study results. “For the first time, a significant improvement in overall survival has been demonstrated in previously-treated advanced melanoma patients in a large, randomized Phase 3 study.”
“Results from this ipilimumab study are exciting and show the potential of harnessing the immune system to treat cancers like metastatic melanoma,” said F. Stephen Hodi, M.D., Department of Medicine, Harvard Medical School, Dana-Farber Cancer Institute and lead author on the New England Journal of Medicine paper.
Ipilimumab is a novel T-cell potentiator that specifically blocks the inhibitory signal of CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. Suppression of CTLA-4 can augment the immune system’s T-cell response in fighting disease.
Ipilimumab is an investigational compound and is not currently approved for use by health authorities. Bristol-Myers Squibb is in discussions with health authorities worldwide and expects to submit applications for regulatory approval of ipilimumab in advanced melanoma this year.
Source: Bristol-Myers Squibb, USA