New updated results from a pivotal phase II trial evaluating lenalidomide (Revlimid) in patients with myelodysplastic syndromes (MDS) were presented by Dr. Alan List, from the H. Lee Moffitt Cancer Center & Research Institute, at the 9th International Symposium on MDS in Florence, Italy. Breakthrough data presented at the meeting showed that lenalidomide can provide long-term survival benefit and prevent disease progression in MDS patients with chromosome 5q deletion.
"These landmark data demonstrate that Revlimid, in many cases, can help patients with MDS live transfusion-free for several years. More importantly, we found that Revlimid can provide a significant long-term survival advantage, with 87% of cytogenic responders having a 10-year survival estimate," said Dr. List, professor of oncology and medicine and chief, division of malignant hematology at Moffitt, and lead investigator of the study. "It is very rewarding to see patients treated with Revlimid, living longer, living 3 or 4 years transfusion-free and having a better quality of life overall."
The updated data presented by Dr. List at this year's Symposium showed that patients with MDS with chromosome 5q deletion who received lenalidomide were able to remain transfusion-free for an average of 2.2 years and, after 4 years, patients were still responding to treatment. Additionally, among patients who showed a cytogenic response to lenalidomide, 87% had a 10-year survival estimate compared to only 4% of noncytogenic responders.
Additional data from a retrospective analysis of a German database on MDS patients treated with lenalidomide were also presented at the Symposium and showed that the agent can prevent disease progression in patients with MDS with chromosome 5q deletion. This is noteworthy because, according to the MDS Foundation, approximately 30% of patients diagnosed with MDS will typically progress to acute myeloid Leukemia (AML). Patients receiving lenalidomide also had a statistically significant overall survival advantage.
Lenalidomide is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. The drug is also used as treatment in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy.