Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that abstracts for the upcoming Society for Melanoma Research meeting have been published online in the organization’s official journal at
. The publication includes an abstract reviewing results from a phase III metastatic melanoma study with ABRAXANE
(paclitaxel protein-bound particles for injectable suspension) (albumin-bound).
In the randomized, open-label, international study (CA033), ABRAXANE showed a statistically significant improvement in progression-free survival (PFS) in chemotherapy-naïve patients with metastatic melanoma compared to patients receiving dacarbazine chemotherapy (4.8 vs. 2.5 months, respectively (HR:0.792; 95.1% CI: 0.631, 0.992;
=0.044)). An interim analysis of overall survival, the secondary endpoint, shows a trend in favor of the ABRAXANE arm compared to treatment with dacarbazine (12.8 and 10.7 months, respectively (HR:0.831; 99.9% CI: 0.578, 1.196;
“Metastatic melanoma presents significant treatment challenges due in part to limited therapies, low survival rates at diagnosis and no advances in chemotherapy in thirty-seven years,” said Dr. Evan M. Hersh, lead principal investigator and Professor of Medicine at the University of Arizona College of Medicine and Arizona Cancer Center, Tucson, AZ. “Despite advances with targeted treatment and immunotherapies, there is still a need for new agents including chemotherapy treatments for patients with metastatic melanoma.”
The safety profile of ABRAXANE observed in the CA033 study is comparable with other ABRAXANE pivotal clinical trials. The most common grade ≥3 treatment-related adverse events reported in ≥10% patients were neuropathy (ABRAXANE: 25% vs. dacarbazine: 0%), neutropenia (ABRAXANE: 20% vs. dacarbazine: 10%). The median time to neuropathy improvement with ABRAXANE was 28 days.
These results will be presented at the Society for Melanoma Research 2012 Congress on Sunday, November 11
, in Hollywood, CA.
Future regulatory and clinical strategies are being reviewed in light of these results.
These results are from an investigational study. ABRAXANE is not approved for the treatment of metastatic melanoma.