Celgene Stays on a Roll with Hitting Primary Endpoints in Melanoma and Psoriatic Arthritis Trials

Andrew Klips  |

Less than one month ago, Celgene Corp. (CELG) reported that its international unit had met primary efficacy endpoints in a second phase III clinical trial for its apremilast treatment for psoriatic arthritis, an inflammatory joint condition that affects some psoriasis patients. The company plans to file a New Drug Application with the U.S Food and Drug Administration in the first quarter of 2013 for apremilast as a new psoriatic arthritis therapy.

Separately in September, the Summit, NJ-based company said that apremilast met its goal as a treatment for Behcet's disease in a phase II clinical trial. Behcet's disease is a rare disease that causes persistent oral and genital ulcers, skin lesions, and other problems including inflammation of the eyes.

Today, Celgene continued its string of promising clinical data in saying that the primary endpoint was met in a phase III investigational study of its breast cancer treatment Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in patients with metastatic melanoma. Abraxane is already FDA-approved as a treatment for breast cancer.

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The CA033 study is a Celgene-sponsored, open-label, controlled, randomized study comparing Abraxane to dacarbazine, or DTIC (the only chemotherapy approved for metastatic melanoma by the FDA since 1975), in patients with metastatic melanoma. 529 chemotherapy-naïve patients were randomized to receive either Abraxane (150mg/m2 weekly for 3 out of 4 weeks) or DTIC (1000 mg/m2 every three weeks).

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, according to the company.

Melanoma is an aggressive form of skin cancer characterized by uncontrolled growth of melanocytes in the skin. It is the deadliest form of skin cancer typically resulting in a brief life span if not caught early and allowed to spread to other parts of the body. About 132,000 new cases of melanoma are diagnosed worldwide, according to the World Health Organization with the incidence rate growing by 1000 percent in the past half-century. The American Cancer Society estimates there will be more than 76,000 new cases of melanoma and nearly 9,200 melanoma deaths this year in the United States.

Celgene added Abraxane to its pipeline when it acquired original owner Abraxis BioScience in June 2010 for $71.93 per share in a deal valued at $2.9 billion in cash and stock as it looked to bolster its solid tumor drug presence in addition to it blood cancer therapies.

Investors are also keen for Celgene to announce results from an Abraxane phase III study in pancreatic cancer which, according to the company, will be in a "few weeks" or "very soon" as they said at the European Society of Medical Oncology conference last weekend. Optimism amongst experts in oncology is very high for promising result on that front as well.
Shares closed at $76.78 Monday and are ahead by about 25 percent in the last 52 weeks.

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