Phase 3 Trial Update of Abraxane for Advanced Melanoma

Celgene announced results from a Phase 3 metastatic melanoma study (CA033) of Abraxane (paclitaxel [bound to albumin (human)]).

The trial was a randomized, open-label, international study conducted in chemotherapy-naïve patients with Stage IV metastatic melanoma. In the study, 529 chemotherapy-naïve patients were randomized to receive either Abraxane 150mg/m2 weekly for 3 out of 4 weeks (n=264) or standard chemotherapy, dacarbazine (DTIC-Dome; Bayer) 1000 mg/m2 every three weeks (n=265). The primary endpoint was progression-free survival (PFS) based on blinded assessment of CT scans obtained every 8 weeks, evaluated per RECIST. The secondary endpoint was overall survival (OS) and other endpoints included objective response rate (ORR), disease control rate (DCR), and safety/tolerability.

Abraxane showed a statistically significant improvement in PFS compared to patients receiving dacarbazine chemotherapy (4.8 vs. 2.5 months, respectively [HR: 0.792; 95.1% CI: 0.631, 0.992; P=0.044]). An interim analysis of OS 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; P=0.094]).

Abraxane is an albumin-bound form of paclitaxel that is manufactured using patented nab technology. Abraxane is approved for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; prior therapy should have included an anthracycline unless clinically contraindicated. Abraxane is also approved for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

For more information call (800) 890-4619 or visit www.celgene.com.