Celgene reports positive results from Phase III trial of Revlmid in patients with non-del-5q MDS

Results from the multicenter, randomized, placebo controlled Phase III trial (MDS-005) showed that significantly more patients treated with lenalidomide achieved red-blood-cell-transfusion independence (RBC-TI) of at least 56 days compared with placebo, which is the primary endpoint of the trial.

Patients who had a score change of at least one from baseline were assessed, while clinically relevant domains of HRQoL were pre-selected as fatigue, dyspnea, physical functioning, emotional functioning and global quality of life.

The company said that in the current analysis, HRQoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire at baseline, every 12 weeks thereafter and at discontinuation.

According to the company, at week 12, mean changes in HRQoL scores from baseline were not significantly different between treatment arms for the pre-selected domains and at week 24, HRQoL score changes favored lenalidomide versus placebo for all pre-selected domains.

Based on the results of MDS-005, the company intends to submit a regulatory filing with the US Food and Drug Administration (FDA) in the second half of 2015.

Currently, Revlimid is not approved for the treatment of patients with non-del-5q MDS and in the US the drug is approved in combination with dexamethasone to treat patients with multiple myeloma.

The drug is also approved in combination with dexamethasone to treat patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, including Europe, the Americas, the Middle East and Asia.

Revlimid is also approved in combination with dexamethasone to treat patients whose disease has progressed after one therapy in Australia and New Zealand.