Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The New England Journal of Medicine has reported encouraging clinical data from two Celgene-sponsored multi-centered, randomized, double-blind, placebo-controlled Phase III pivotal studies evaluating lenalidomide plus dexamethasone in previously treated multiple myeloma patients.
Subscribe to our email newsletter
The updated clinical data from the pivotal international Phase III trial reported median time-to-disease progression (TTP) in patients receiving lenalidomide plus dexamethasone compared to patients receiving dexamethasone plus placebo (p< 0.0001). In the North American Phase III trial (MM-009) the updated clinical data reported overall survival and median TTP in patients receiving lenalidomide plus dexamethasone compared to patients receiving dexamethasone plus placebo (p< 0.0001). The median TTP with lenalidomide plus dexamethasone was 11.3 months, compared with 4.7 months for dexamethasone plus placebo (p< 0.0001). This constituted the longest TTP seen to date in previously treated multiple myeloma patients in Phase III trials. Overall response rate with lenalidomide plus dexamethasone was 60.2%, compared with 24% for dexamethasone plus placebo (p< 0.001). These randomized Phase III trials have produced the highest response rate to date of any Phase III trial in previously treated patients with multiple myeloma. In addition, patients in the two Phase III trials showed the greatest improvement to date in TTP and deepest response rates if used earlier on in the treatment. Finally, patients in the trial showed the greatest duration of response at more than 15 months.