Patients with myelodysplastic syndromes treated with Revlimid are living longer and remaining transfusion independent

May 18 2007

New updated results from a pivotal Phase II trial evaluating Revlimid in patients with an incurable blood cancer known as 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 currently taking place in Florence, Italy.

Breakthrough data presented at the meeting showed that Revlimid, or 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 percent of cytogenic responders having a ten-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 three or four 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 Revlimid were able to remain transfusion free for an average of 2.2 years and, after four years, patients were still responding to treatment. Additionally, among patients who showed a cytogenic response to Revlimid, 87 percent had a ten year survival estimate compared to only four percent of non-cytogenic responders.

Additional data from a retrospective analysis of a German database on MDS patients treated with Revlimid was also presented at the Symposium and showed that Revlimid can also prevent disease progression in patients with MDS with chromosome 5q deletion. This is noteworthy because, according to the MDS Foundation, approximately 30 percent of patients diagnosed with MDS will typically progress to acute myeloid leukemia (AML). Patients receiving Revlimid also had a statistically significant overall survival advantage.

MDS, a cancer in which the bone marrow fails to make enough functioning blood cells, affects 300,000 people worldwide killing 60,000 to 70,000 a year. MDS patients suffer from anemia and fatigue and need whole-body blood transfusions as much as twice a month. Repeated transfusions can lead to a toxic buildup called "iron overload" that severely damages the heart, liver and pancreas, and patients eventually succumb to the disease.

Revlimid is indicated for the treatment of patients with transfusion- dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid is also used as treatment in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy.