Updated clinical data from two Phase III pivotal studies evaluating Revlimid ( Lenalidomide ) plus Dexamethasone in previously treated multiple myeloma patients were presented during the 47th American Society of Hematology ( ASH ) Meeting in Atlanta.

The updated clinical data from the pivotal International Phase III trial ( MM-010 ), demonstrated that the combination of Lenalidomide plus Dexamethasone led to a statistically significant improvement in median time to disease progression ( p=0.001 ).

The updated clinical data from the pivotal North American Phase III trial ( MM-009 ), reported that the combination of Lenalidomide plus Dexamethasone led to a statistically significant improvement in overall survival in addition to a statistically significant improvement in median time to disease progression.

Data from the International study reported that:

- The median time-to-disease progression with Lenalidomide plus Dexamethasone was 49 weeks, compared with 20 weeks for placebo plus Dexamethasone ( p<0.001 )

- Best response rate with Lenalidomide plus Dexamethasone was 59 percent, ( p<0.001 ) compared with 24 percent for placebo plus Dexamethasone

- Complete response ( CR ) and near complete response ( nCR ) rate ( based on EBMT criteria ) with Lenalidomide plus Dexamethasone was 17 percent ( p<0.001 ), compared with 4 percent for placebo plus Dexamethasone

The updated clinical data from the pivotal North American Phase III trial ( MM-009 ), reported that the combination of Lenalidomide plus Dexamethasone led to a statistically significant improvement in overall survival in addition to a statistically significant improvement in median time to disease progression.

Both trials are randomized, double-blind, placebo-controlled, phase III studies using Lenalidomide plus Dexamethasone versus placebo plus Dexamethasone in relapsed or refractory multiple myeloma patients.

An Independent Data Monitoring Committee reviewed the pre-specified interim analysis and determined that both Phase III trials overwhelmingly exceeded the pre-specified efficacy stopping rule of p<0.0015 for the primary endpoint, time-to-disease progression.

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 Lenalidomide 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 Lenalidomide 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 Lenalidomide 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.

Lenalidomide is a member of a group of novel compounds, ImiDs that are being evaluated by Celgene as a treatment for a broad range of hematology and oncology conditions, including; multiple myeloma, myelodysplastic syndromes ( MDS ), chronic lymphocytic leukemia as well as solid tumor cancers. REVLIMID affects multiple intracellular biological pathways.

Source: Celgene, 2005


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