ATLANTA, June 5, 2006 /PRNewswire-FirstCall via COMTEX/ — Celgene Corporation (CELG : news, chart, profile ) announced updated clinical data from two multi-centered, randomized, double-blind, placebo-controlled Phase III pivotal studies evaluating lenalidomide plus dexamethasone in previously treated multiple myeloma patients were presented at the 42nd American Society of Clinical Oncology (ASCO) Meeting in Atlanta, Georgia on Monday, June 5, 2006.
The updated clinical data from the pivotal North American Phase III trial
(MM-009) reported overall survival (p<0.0001) in addition to median time to disease progression (p<0.0001) in patients receiving lenalidomide plus dexamethasone compared to patients receiving dexamethasone plus placebo. The updated clinical data from the pivotal International Phase III trial
(MM-010) reported overall survival (p=0.03). As of June 2006, median overall survival in the International trial in patients treated with lenalidomide plus dexamethasone has not been reached as compared to 20.6 months with dexamethasone plus placebo.
Dr. Weber presented updated results from the North American Phase III special protocol assessment trial (MM-009) that reported:
* The median overall survival (OS) with lenalidomide plus dexamethasone
was 29.6 months, compared with 20.2 months for dexamethasone plus
* The median time-to-disease progression (TTP) with lenalidomide plus
dexamethasone was 11.1 months, compared with 4.7 months for
dexamethasone plus placebo (p<0.0001)
* Best response rate with lenalidomide plus dexamethasone was 59.4
percent, compared with 21.1 percent for dexamethasone plus placebo
* Complete response (CR) rate (based on EBMT criteria) with lenalidomide
plus dexamethasone was 12.9 percent, compared with 0.6 percent for
dexamethasone plus placebo (p<0.001)
* The most common side effects observed in this trial with the
combination of lenalidomide and dexamethasone were constipation,
diarrhea and neutropenia
Both trials were randomized, double-blind, placebo-controlled, phase III studies using lenalidomide plus dexamethasone versus dexamethasone plus placebo in previously treated multiple myeloma patients.
Patients in both lenalidomide 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.
These trials were designed to investigate the effectiveness and safety of cyclic dosing of lenalidomide at 25mg combined with high-dose dexamethasone
(HDD) compared with placebo and HDD in previously treated patients with multiple myeloma. These trials enrolled 705 patients and are being conducted in 97 sites internationally. Lenalidomide and HDD are given in 28-day
cycles: lenalidomide 25 mg once daily on days 1-21 every 28 days, and HDD 40 mg on days 1-4, 9-12 and 17-20 every 28 days. After four cycles the HDD schedule is reduced to 40 mg on days 1-4 every 28 days). The primary endpoint of the study is time-to- disease progression calculated as the time from randomization to the first documentation of progressive disease based on EBMT myeloma response criteria.
In the North American trial, patients treated with lenalidomide and dexamethasone had an increase in side effects as compared to patients treated with dexamethasone plus placebo. Grade 3/4 toxicities included neutropenia, thrombocytopenia and anemia. Deep vein thrombosis and pulmonary embolism occurred in 14.1 percent of patients treated with lenalidomide plus dexamethasone, compared to 3.4 percent of patients treated with dexamethasone plus placebo.