Good news seems to find its way to Celgene's (NASDAQ: CELG ) door frequently these days. The company announced positive results today from a late-stage study of Revlimid with dexamethasone in treating newly diagnosed multiple myeloma. Shares jumped more than 6% on the news.
FIRST things first
This phase 3 clinical study, called FIRST (for Front-Line Investigation of Revlimid/Dexamethasone vs. Standard Thalidomide), included more than 1,600 patients -- making it one of the largest studies ever conducted for newly diagnosed multiple myeloma. Some of the patients received Revlimid with low doses of dexamethasone, while other patients received a regimen consisting of melphalan, prednisone and thalidomide, abbreviated as MPT.
Celgene's primary endpoint for the study focused on significant improvement in progression-free survival for the group of patients taking the Revlimid combo. Details have not yet been released, but the company said that this primary endpoint was met with statistical significance. No information was shared at this point about the secondary endpoints for the study -- overall survival, response rate, quality of life and safety. Celgene plans to give more details at an upcoming medical conference.
Whatever that additional information may reveal, the results from the FIRST study appear to have been solid. Celgene says it plans to actively pursue discussions with regulatory authorities in the U.S., Europe, and other countries.
As the market reaction shows, the FIRST results are clearly great news for Celgene. Revlimid already stands as a leader in second-line treatment of multiple myeloma. Gaining approval for newly diagnosed cases of the disease opens up more potential.
At this point, there don't appear to be any storm clouds on the horizon for Revlimid. Approval for the new indication should help it compete against Takeda's Velcade. Onyx Pharmaceuticals (NASDAQ: ONXX ) brought Kyprolis to the market. However, the drug really isn't a rival for Revlimid right now, since it is only approved as a third-line treatment for multiple myeloma. Kyprolis could pull some sales away from Celgene's Pomalyst, but I don't think there will be a significant impact.
AbbVie (NYSE: ABBV ) and Bristol-Myers Squibb (NYSE: BMY ) are moving ahead with elotuzumab in three different clinical studies. However, one of those is a phase 2 study that will complete in 2015 and would then presumably require a phase 3 study to follow. Another is a phase 3 study that doesn't finish until 2018. The third phase 3 study is scheduled to complete in early 2014. But it actually involves elotuzumab with Revlimid, so even a success shouldn't hurt Celgene's sales.
The announcement today adds to the momentum that Celgene has built up over the past couple of years. I expect that momentum to continue. Good news seems likely to keep showing up at this biotech's door for the foreseeable future.
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