News Feature | September 8, 2014

Celgene's Combination Regimen For Multiple Myeloma Reaches Primary Endpoint

By Lori Clapper

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Celgene announced that its findings from its open-label phase III randomized study of Revlimid (lenalidomide) in combination with dexamethasone had met its primary endpoint of progression free survival (PFS).  The research was performed in newly diagnosed multiple myeloma (NDMM) patients who are not candidates for stem cell transplants.

The results, which were published in the September 4th issue of the New England Journal of Medicine, showed that the combination of Revlimid and dexamethasone in surviving patients after 37 months impacted median progression-free survival in the following ways:

  • 25.5 months with continuous oral lenalidomide plus low-dose dexamethasone (Rd)
  • 20.7 months with a fixed course of oral lenalidomide plus low-dose dexamethasone (Rd18)
  •  21.2 months with melphalan, prednisone, and thalidomide or MPT.

The pre-planned interim analysis of overall survival demonstrated a 22 percent reduction in risk of death for continuous Rd vs. MPT, although the difference did not cross the pre-specified superiority boundary.

Additional secondary endpoints showed response rates were also significantly better with continuous Rd (75 percent) and with Rd18 (73 percent) than with MPT (62 percent; P<0.001) for both comparisons.

In February 2014, Celgene submitted REVLIMID/ dexamethasaone combination for the treatment of newly diagnosed multiple myeloma patients with the European Medicines Agency (EMA). This was followed by an application to the FDA in April 2014.

Celgene recently announced in August that it had paired up with Bristol-Myers Squibb to carry out a Phase I clinical trial assessing the safety, tolerability, and preliminary efficacy of another combination cancer treatment.  This particular investigational regimen included Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), and Celgene's nab technology-based chemotherapy Abraxane. The study is intended to explore a variety of tumor types, including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC). The proprietary name Opdivo has been proposed in the U.S. and other countries, but has not been approved by regulatory authorities.