Celgene Presents Revlimid Data - Analyst Blog

Recently, Celgene Corp. (CELG) announced positive results from the planned second interim analysis of a late-stage study (n=459) of continuous Revlimid (lenalidomide) for treating patients, aged 65 or more, suffering from newly diagnosed multiple myeloma. The data, presented during the European Haematology Association's annual congress in Spain, demonstrated improvement in progression-free survival (PFS).
 
The patients enrolled in the study were divided into three groups. One group, consisting of 152 members, evaluated patients receiving Revlimid combined with melphalan and prednisone, followed by Revlimid alone (MPR-R). The second group, comprising 153 members, evaluated patients receiving Revlimid in conjunction with melphalan and prednisone, followed by placebo (MPR). The third group, comprising 154 subjects, evaluated patients receiving placebo, melphalan and Revlimid, followed by placebo (MP).
 
The interim analysis from the randomized, double-blind study revealed a median PFS of 13 months in the MP arm.  However, the median PFS in the MPR-R arm has not yet been established. The subjects in the MPR-R arm displayed a 58% reduction in the risk of disease progression compared to those in the MP arm. This reflected an improvement from the reduction in risk of disease progression reported at the first interim analysis in December 2009. At the time of the second analysis, it was projected that 55% of patients in the MPR-R arm would remain progression free after two years as opposed to only 16% in the MP arm.
 
Revlimid is currently approved for myelodysplastic syndromes (MDS) and second-line multiple myeloma (MM). If Revlimid is approved as a first-line therapy for patients suffering from multiple myeloma, a type of blood cancer in which the malignant plasma cells are overproduced in the bone marrow, then it would be a major boost for the company’s top line.
 
Our Take
 
Apart from Revlimid, the company boasts of Vidaza, Thalomid and Istodax (gained through the recent acquisition of Gloucester Pharmaceuticals) in its product portfolio. Although Celgene, with Vidaza and Revlimid, will dominate the myelodysplastic syndromes market, it will face tough competition in the multiple myeloma market. The negative growth of its other product Thalomid is likely to continue due to the availability of better alternatives in the market for multiple myeloma. We believe that the addition of Istodax is aimed to make up for the disappointing performance of Thalomid.
 
Currently, we are Neutral on Celgene. Our Neutral long-term stance on the company indicates that the stock is expected to perform in line with the US equity market over the next six to twelve months. We advise investors to retain them over the time period.
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