Study of Lenalidomide in Newly Diagnosed Multiple Myeloma Patients Reaches Primary Endpoint

A phase III study of Revlimid in combination with dexamethasone in patients with newly diagnosed multiple myeloma met its primary endpoint of PFS.

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A phase III study of lenalidomide (Revlimid) in combination with dexamethasone in patients with newly diagnosed multiple myeloma met its primary endpoint of progression-free survival (PFS), with the combination exhibiting a statistically significant improvement over the control arm regimen, according to an announcement made by Celgene, the drug’s manufacturer.

Lenalidomide, an analog of thalidomide with anti-angiogenic, antitumorigenic, and immunomodulating activity, was previously approved for the treatment of multiple myeloma in patients who have received treatment with at least one prior therapy. Though it has been studied in newly diagnosed patients before, it is not currently approved by the FDA for use in this patient population.

In the phase III, randomized, international Front-Line Investigation of Revlimid/Dexamethasone versus Standard Thalidomide (FIRST) trial, also known as MM-020/IFM 07-01, 1623 patients who were ineligible for autologous stem cell transplantation received one of three regimens: continuous oral lenalidomide plus low-dose dexamethasone until disease progression; lenalidomide plus low-dose dexamethasone for eighteen 28-day cycles (72 weeks); or melphalan, prednisone, and thalidomide (MPT) for up to twelve 42- day cycles (72 weeks).

Celgene did not disclose specific data regarding the endpoint. However, in a statement, the company said that safety and efficacy in the treatment arms is ongoing and the results of the trial are expected to be presented at a future conference or meeting. The company did not make any statements regarding secondary endpoints, which include overall survival, response rate, quality of life, and safety.

Lenalidomide has been explored for use in a number of hematologic malignancies. Earlier this year, the drug received approval from the FDA for the treatment of mantle cell lymphoma in patients who have relapsed or whose disease has progressed after two prior therapies including at least one prior treatment with bortezomib.

In the US, lenalidomide is also approved for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. However, the UK’s National Institute for Health and Care Excellence (NICE) issued a draft guidance that raised issues over whether the price of lenalidomide was justified and whether it was capable of extending the lives of patients with MDS. If the draft guidance is confirmed after a consultation process, the drug will not be recommended for use in Britain.