Celgene's Abraxane meets main goal in melanoma trial; reviews nanomedicines

Celgene International Sarl, a subsidiary of the USA’s Celgene Corp (Nasdaq: CELG) has announced results of its Phase III, randomized, international study (CA033) of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in chemotherapy-naive patients with metastatic melanoma. In the study, the primary endpoint was met with patients receiving Abraxane demonstrating a statistically-significant improvement in progression-free survival compared to patients receiving dacarbazine (DTIC) chemotherapy.

The safety profile of Abraxane observed in the CA033 study is consistent with other Abraxane pivotal clinical trials. Data from this study will be presented at the Society for Melanoma Research (SMR) Congress 2012 in Los Angeles in November. Future regulatory and clinical strategies are being reviewed in light of these results.

The CA033 study is a Celgene-sponsored, open-label, controlled, randomized trial comparing Abraxane to standard chemotherapy, DTIC, in patients with metastatic melanoma. DTIC is the only chemotherapy approved since 1975 by the US Food and Drug Administration for metastatic melanoma. In the study, 529 chemotherapy-naïve patients were randomized to receive either Abraxane (150mg/m2 weekly for three out of four weeks) or DTIC (1000 mg/m2 every three weeks). The primary study endpoint was independently-assessed progression free survival. Secondary endpoints included overall survival, overall response rate and disease control, safety and tolerability.