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26 Jul 2016

Celgene decides against pursuing new indication for its Revlimid

Data from a Phase III study indicate overall survival showed no benefit of Revlimid.

Celgene Corporation and the Lymphoma Study Association (LYSA) have announced that the Lymphoma Academic Research Organisation (LYSARC) reported initial data from a Phase III, randomized, double-blind, international clinical study (REMARC). This investigational study evaluated maintenance therapy with Revlimid (lenalidomide) compared with placebo in diffuse large B-cell lymphoma (DLBCL) patients responding to first-line rituximab plus CHOP chemotherapy (R-CHOP) induction therapy. LYSARC sponsored the study under a Clinical Trial Agreement with Celgene.

REMARC achieved the primary endpoint of a statistically significant improvement in progression-free survival for patients receiving Revlimid. The interim analysis of overall survival, a key secondary endpoint, showed no benefit in the Revlimid arm. Based upon these interim results, Celgene does not currently plan to seek approval for this indication. "We thank the patients and their families for participating in the REMARC trial and look forward to presenting these important data at a future hematology conference," said Bertrand Coiffier, Professor of Hematology, Hospices de Lyon and University Claude Bernard Lyon 1 and Principal Investigator, REMARC. "We are continuing to partner with LYSA to complete the analyses of the REMARC study," said Michael Pehl, President Hematology and Oncology of Celgene. "We remain committed to finishing the four ongoing Phase III trials evaluating Revlimid and are confident about its potential as a treatment option across different settings in lymphoma."

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