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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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Data from at Least 18 Phase III Trials Expected from Mid-2016 Through Mid-2018

2016

REMARC trial with REVLIMID® in DLBCL maintenance
CONTINUUM® trial with REVLIMID® in CLL maintenance
ETNA trial with ABRAXANE® in neoadjuvant breast cancer
PSA-006 trial with OTEZLA® in biologic naïve psoriatic arthritis
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Source: press release, 1/28/16. http://ir.celgene.com/releasedetail.cfm?ReleaseID=952157

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Jacqualyn A. Fouse, PhD, President, Global Hematology and Oncology, gave guidance for data from the REMARC trial. She stated, "In 2016, we will see the read out of the REMARC trial in diffuse large B-cell lymphoma and our overall program for Revlimid in lymphoma will continue to advance."
Source: Q4 2014, earnings conference call, 1/28/16.

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Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line
Enrollment: 650
Study Start Date: April 2009
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT01122472?term=REMARc&rank=1

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
REVLIMID (lenalidomide) NHL B-Cell Oncology HematologicNon-Hodgkins Lymphoma (NHL) (B-cell)Thalidomide analogImmune system

Mechanism of action: REVLIMID (lenalidomide) is a thalidomide analog with potential antineoplastic activity. Lenalidomide inhibits TNF-alpha production, stimulates T cells, reduces serum levels of the cytokines vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF), and inhibits angiogenesis. This agent also promotes G1 cell cycle arrest and apoptosis of malignant cells.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-09-01 - 2016-12-31

Results:

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Jul 25, 2016

Celgene and LYSARC Provide Update on the Phase III ‘REMARC' Study of REVLIMID® Maintenance Treatment in Patients with Diffuse Large B-Cell Lymphoma Responding to First-Line R-CHOP Therapy

SUMMIT, N.J. & LYON, France--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) and the Lymphoma Study Association (LYSA) today 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."

A Broad Phase III Program in NHL Underway; Data from Additional Trials Expected in 2017

The REMARC study is part of a broad research program at Celgene focused on multiple areas of non-Hodgkin lymphoma. In addition to the REMARC study, REVLIMID® is also being evaluated in:

RELEVANCE®, a combination with rituximab in previously untreated follicular lymphoma;
AUGMENT®, a combination with rituximab in relapsed/refractory follicular and marginal zone lymphoma;
MAGNIFY®, a combination with rituximab in relapsed/refractory follicular, marginal zone and mantle cell lymphoma; and,
ROBUST®, a combination with R-CHOP in previously untreated ABC-subtype DLBCL.
Data from RELEVANCE® and AUGMENT® are expected in the first and second half of 2017, respectively. Beyond REVLIMID®, Celgene is also exploring multiple clinical candidates in non-Hodgkin lymphomas and T-cell lymphomas.

REVLIMID® is not approved for use in DLBCL.
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Source: press release, 7/25/16. http://ir.celgene.com/releasedetail.cfm?ReleaseID=981035

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