Results of a University of Arizona Cancer Center’s scientist–led clinical trial show that a drug already approved for breast and lung cancer improved progression-free survival in patients with metastatic melanoma.
The findings of the Phase III study of nab-paclitaxel, brand name Abraxane®, therapy compared to standard dacarbazine therapy were presented at the Society for Melanoma Research (SMR) in California Nov. 11.
Evan Hersh, MD, a professor of medicine at the UA College of Medicine, said the UACC was the site of the initial Phase I and II studies when researchers first detected activity of nab-paclitaxel in melanoma patients. The drug, originally developed by Abraxis BioScience, was later acquired by Celgene Corporation. Dr. Hersh said he chaired a Phase II study which showed activity in patients that had one or two previous treatments for their melanoma as well as others who had a more intensive treatment for their disease. Dr. Hersh then chaired the Phase III study with Celgene.
Melanoma is the most serious form of skin cancer, and while it occurs less often than non-melanoma skin cancers, it causes more deaths. There have been no chemotherapy drugs approved for metastatic melanoma since 1975, however there has been considerable progress with so-called targeted therapy and with immunotherapy.
“Metastatic melanoma presents significant treatment challenges due in part to limited therapies, low survival rates at diagnosis and no advances in chemotherapy in 37 years,” Dr. Hersh said. “Despite advances with targeted treatment and immunotherapies, there is still a need for new agents including chemotherapy treatments for patients with metastatic melanoma as the long term survival of patients with metastatic disease is poor.”
In the Phase III study, a randomized, open-label multicenter multinational study, nab-paclitaxel showed a statistically significant improvement in median progression-free survival in chemotherapy-naïve patients with metastatic melanoma compared to patients receiving dacarbazine chemotherapy (4.8 versus 2.5 months). An interim analysis of overall survival, the secondary endpoint, shows a trend in favor of the nab-paclitaxel arm compared to treatment with dacarbazine (12.8 and 10.7 months, respectively).
Dr. Hersh said it is hoped that nab-paclitaxel and other agents under development will eventually provide a major improvement in the survival of melanoma patients with spread throughout the body.
The melanoma program of the UACC consists of a team of medical, dermatological, surgical and radiation oncologists as well as a group of basic scientists who are devoted to development of an improved understanding, prevention and treatment of all stages of malignant melanoma.
Nov. 13, 2012