December 9, 2007 / 10:29 PM / 12 years ago

UPDATE 1-Celgene's Revlimid shows survival benefit-trial

(Updates with details, changes dateline, previous NEW YORK)

BOSTON, Dec 9 (Reuters) - Celgene Corp CELG.O said on Sunday that its multiple myeloma drug Revlimid sharply increased survival when combined with a low dose of the steroid dexamethasone in previously untreated patients.

Data presented at the annual meeting of the American Society of Hematology showed a 96 percent survival rate at one year and 87 percent at two years in patients who took the low-dose combination treatment.

That compared to an 88 percent survival rate at one year for patients who received Revlimid together with a high dose of dexamethasone and a rate of 75 percent at two years in the high-dose group.

The trial, conducted by the Eastern Cooperative Oncology Group, showed that the ultimate overall survival rates did not necessarily correlate with early patient responses to the regimes. The best overall patient response for the high-dose arm was 82 percent, compared to 71 percent in the low-dose arm.

“The question is: Why?” said Dr. Vincent Rajkumar, a Mayo Clinic Cancer Center hematologist and lead investigator on the study. “There are some answers we are getting from analyzing the study. About half the deaths in the high-dose dex arm were related to toxicity, and others also due to disease progression.”

Last April, the ECOG Data Monitoring Committee reviewed the preliminary results of the trial and recommended patients in the high-dose dexamethasone arm of the trial be moved to the low-dose arm because of the clear survival benefit.

The latest data showed that reducing the amount of dexamethasone in the treatment combination also reduced the number of serious side effects such as deep vein thrombosis. (Reporting by Toni Clarke and Ed Leefeldt; Editing by Jan Paschal)

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