ASH: Revlimid plus Dex better than Dex alone

Celgene Corporation announced updated clinical data from two Phase III studies evaluating REVLIMID (lenalidomide) plus dexamethasone in previously treated multiple myeloma patients. The updated clinical data from the pivotal International Phase III trial (MM-010), demonstrated that the combination of REVLIMID plus dexamethasone led to a statistically significant improvement in median time to disease progression. The updated clinical data from the pivotal North American Phase III trial (MM-009), reported that the combination of REVLIMID plus dexamethasone led to a statistically significant improvement in overall survival in addition to a statistically significant improvement in median time to disease progression. As of June 2005, median overall survival in patients treated with REVLIMID plus dexamethasone has not been reached as compared to 104 weeks with dexamethasone plus placebo.

The data were presented at the plenary session during the 47th American Society of Hematology (ASH) Meeting in Atlanta, on Sunday, December 11. Data from the International study reported that:

• The median time-to-disease progression with REVLIMID plus dexamethasone was 49 weeks, compared with 20 weeks for placebo plus dexamethasone
• Best response rate with REVLIMID plus dexamethasone was 59 percent, compared with 24 percent for placebo plus dexamethasone
• Complete response and near complete response rate with REVLIMID plus dexamethasone was 17 percent, compared with 4 percent for placebo plus dexamethasone
• Side effects were well characterized and manageable; the combination of REVLIMID and dexamethasone appeared to be well tolerated with constipation, diarrhea and neutropenia being most common.

Consistent with previous interim findings, results showed best response rates of 59% in patients treated with REVLIMID plus dexamethasone, compared to 24% of patients treated with placebo plus dexamethasone.

Patients in both REVLIMID trials had been heavily treated prior to enrollment, many having failed three or more rounds of therapy with other agents. In addition, more than 50 percent of patients in the study had undergone stem cell transplantation.

In both trials, patients treated with REVLIMID and dexamethasone had an increase in side effects as compared to patients treated with placebo plus dexamethasone. Grade 3/4 toxicities included neutropenia, thrombocytopenia and anemia. Deep vein thrombosis occurred in 4.5 percent and 13.5 percent of patients treated with REVLIMID plus dexamethasone, compared to 5.0 percent and 3.5 percent of patients treated with placebo plus dexamethasone in the International and North American trials, respectively. Pulmonary embolism occurred in 4.0 percent and 2.9 percent of patients treated with REVLIMID plus dexamethasone, compared to 1.1 percent and 0.6 percent of patients treated with placebo plus dexamethasone in the International and North American trials, respectively.

Source: www.celgene.com