ABRAXANE received FDA approval for the first-line treatment of patients with advanced NSCLC in October, 2012. Through regional partnerships, Celgene has NSCLC applications under review in Japan, Australia, and New Zealand and anticipates receiving Regulatory Health Authority decisions in first half 2013. In addition, Celgene is evaluating regulatory strategies to obtain NSCLC in other countries.
Positive data from the phase III trial comparing ABRAXANE to dacarbazine in over 510 treatment-naïve metastatic malignant melanoma patients were presented at the Society of Melanoma Research meeting November, 2012. In this trial, chemotherapy-naïve patients with metastatic melanoma treated with ABRAXANE had a progression free survival of 4.8 months versus 2.5 months in patients treated with dacarabzine (HR:0.792; 95.1% CI: 0.631, 0.992; P=0.044). Mature phase III overall survival data are expected in mid-2013.
Inflammation & Immunology
Apremilast: Data from the PALACE-1 trial in psoriatic arthritis were presented at the American College of Rheumatology meeting in November, 2012. Results from PALACE-2 and -3 are expected to be presented in 2013. In addition, results from PALACE-4 in treatment-naïve psoriatic arthritis are expected during the first half of 2013.In January, the Company announced the phase III trials, ESTEEM-1 and -2, achieved a highly statistically significant benefit in the primary endpoint of PASI 75 at week 16 in psoriasis. In addition, patients on apremilast also achieved a statistically significant benefit over placebo in the major secondary endpoint, Static Physician Global Assessment (sPGA). Presentation of the full data set are planned for a medical congress in 2013. The phase II trial (BCT-001) in patients with Behçet’s disease achieved its primary endpoint of demonstrating a statistically significant improvement in the number of oral ulcers at day 85 between apremilast and placebo. Regulatory and clinical strategies are under review for this indication. Enrollment in the phase III POSTURE study of apremilast in ankylosing spondylitis is expected to complete in the second half of 2013. Data are expected in 2014.