Early this morning, Celgene Corporation reported that the company's investigational drug Revlimid, also known as lenalidomide (and previously as CC-5013) has shown outstanding results in the treatment of relapsed or refractory myeloma in two Phase III clinical trials. Click here to see Celgene's press release.
The Independent Data Monitoring Committee (IDMC) responsible for overseeing these two trials found a statistically significant improvement in time to disease progression the primary endpoint of these Phase III trials in patients receiving Revlimid plus dexamethasone compared to patients receiving dexamethasone alone. The trials have been unblinded many months earlier than originally projected.
"This is enormously exciting news for myeloma patients, and it may be exciting news for many other cancer patients too,” said Susie Novis, president of the International Myeloma Foundation. "Although we don't know the detailed results of these trials yet, we do know that:
- The trials overwhelmingly showed a delay in time to disease progression for patients receiving Revlimid compared to original projections.
- The preliminary safety profile was favorable.
- Celgene is allowing all patients in these studies to get Revlimid if they want to.
- Plans are under way to offer expanded access to Revlimid for patients with previously treated myeloma (subject to appropriate regulatory approval)
- There are trials of Revlimid being carried out in several other types of cancer.
"The IMF sincerely hopes that this drug can show similar levels of effectiveness in some other cancers where new treatments are so badly needed,” Susie concluded.
Revlimid is not approved for clinical use in the US or anywhere else in the world. However, it previously demonstrated activity in the treatment of a subset of patients with myelodysplastic syndrome (MDS), a pre-leukemic blood disorder. Celgene is already in process of submitting an NDA for Revlimid based on these MDS data.
Celgene has now started talks with the FDA and with international regulatory authorities about potential approval of Revlimid for myeloma too. According to Jerome Zeldis, MD, PhD, "Following preliminary analysis we plan to use this data as the basis of a regulatory submission to the FDA and EMEA for Revlimid in previously treated multiple myeloma patients.” Dr. Zeldis is Chief Medical Officer and VP, Medical Affairs at Celgene.
The Revlimid Phase III trials included patients with relapsed or refractory multiple myeloma. Patients were randomized to receive Revlimid plus dexamethasone or dexamethasone alone. The trials enrolled 705 patients and were being conducted at 97 sites around the world. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Bladé myeloma response criteria.
Dr. Brian Durie, Chairman of the Board of the International Myeloma Foundation stated, "This announcement makes Revlimid the third new pharmaceutical agent, along with Thalomid and Velcade, to offer hope of extended survival for myeloma patients since late 1999. With progress coming at this pace, there is an increased probability that many myeloma patients and their families can look forward with optimism for even better treatments yet to come.”
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