Revlimid™ Promising for Treatment of Multiple Myeloma

Celgene has a ounced that the results of two clinical trials of Revlimid™ (lenalidomide) for treatment of multiple myeloma will be presented at the 10th International Workshop on Multiple Myeloma in Sydney, Australia April 10-15, 2005. According to interim results, Revlimid ™ provides impre ive activity in patients with multiple myeloma who have sto ed re onding to standard therapies.<1>

Revlimid™ is a derivative of thalidomide, which is a very active agent for the treatment of multiple myeloma but has serious side effects, e ecially thromoembolism. Revlimid™ is reported to have le toxicity than thalidomide but retai antimyeloma effects. Revlimid™ has recently been submitted to the FDA for review of treatment of myelody lastic syndromes (MDS). Revlimid™ is in clinical trials for the evaluation of treatment for other hematologic cancers besides MDS.<2> Revlimid™ prevents the growth of arteries and capillaries that carry nutrients to cancer cells. The deprivation of nutrients to cancer cells halts the progre ion and growth of cancer cells.

Two large clinical trials were recently conducted to compare the addition of Revlimid™ to dexamethasone, versus dexamethasone alone. One trial, the MM-009 trial, was a trial conducted in the United States that included patients with refractory multiple myeloma; 170 were treated with Revlimid™ plus dexamethasone and 170 were treated with dexamethasone only. After more than 15 months follow-up, time to cancer progre ion and overall anti-cancer re o e rates were significantly improved in the group of patients treated with Revlimid™/dexamethasone, compared to those treated with dexamethasone alone. Anti-cancer re o e rates were achieved in 51.3% of patients treated with Revlimid™/dexamethasone, compared with 22.9% of patients treated with dexamethasone only. At the time of last follow-up, the average time to cancer progre ion had not yet been reached in the group of patients treated with Revlimid™/dexamethasone, and was 5 months for those treated with dexamethasone only.

The second large clinical trial to compare Revlimid™ plus dexamethasone to dexamethasone in patients with refractory multiple myeloma was conducted in Europe(MM-010 trial). This trial included 176 patients treated with Revlimid™/dexamethasone and 176 patients treated with dexamethasone only. Again, overall anti-cancer re o e rates and time to cancer progre ion were significantly improved in the group of patients treated with Revlimid™/dexamethasone compared to the group treated with dexamethasone only. Overall anti-cancer re o es were achieved in 47.6% in patients treated with Revlimid™/dexamethasone, compared to only 18.9% in patients treated with dexamethasone only. At a roximately 11 months follow-up, the average time to cancer progre ion had not yet been

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