Shares of Celgene Corporation (CELG) have hit new record highs of $136.36 in Thursday trading after its cancer drug Revlimid met its primary endpoint of progression-free survival in a phase III trial in newly-diagnosed multiple myeloma patients. Patients in the trial were treated with a combination of Revlimid and the steroid dexamethasone.
The combination is already approved in almost 70 countries, including the U.S., for treatment of patients that have already tried at least one other therapy without results, but not in naïve patients. Revlimid is also approved in several countries for a specific population in the treatment of transfusion-dependent anaemia caused by myelodyspastic syndromes as well as in the U.S. for treatment of certain patients with mantle cell lymphoma, an approval garnered in June. Sales in 2012 for Revlimid were about $3.8 billion.
The Revlimid/dexamethasone combo was compared to patients receiving triple-drug regimine of melphalan, prednisone and thalidomide, in one of the largest international studies ever in 1,623 newly-diagnosed multiple myeloma patinets.
The primary endpoint was progression-free survival (meaning the cancer didn’t spread or get worse) with secondary endpoints of overall survival, response rate, quality of life and safety. Celegene said that it plans to present additional information on the trial at an upcoming medical meeting. Further, the company intends to start speaking with regulatory authorities with plans to submit dossiers for registration in the U.S., Europe and other markets.
Celgene had pulled a European marketing application for a broader use of Revlimid a year ago after regulators requested additional data.
No numerical data were disclosed by Celgene at this point.
Multiple myeloma, the second most common form of blood cancer, is formed by malignant plasma cells and eventually ends up disrupting production of healthy blood cells. According to the American Cancer Society, the lifetime risk of getting multiple myeoloma is 1 in 149. The organization estimates that 22,350 new cases will be diagnosed in 2013 with about 10,710 people dying of the disease this year.
Shares of CELG have slipped back slightly for the record intraday highs from this morning, holding ahead by 6.8 percent at $133.53 with two hours left in the trading day. Shares are up by about 70 percent so far this year.
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