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August 13, 2014
16:04 EDTAMGNAmgen says Phase 3 clinical trial FOCUS did not meet primary endpoint
Amgen and its subsidiary, Onyx Pharmaceuticals announced that the Phase 3 clinical trial FOCUS did not meet its primary endpoint of improving overall survival, OS. The 315-patient, open-label study evaluated single-agent Kyprolis® (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. Nearly all patients in the control arm received cyclophosphamide. Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rate of cardiac events observed in the Kyprolis arm was consistent with the current U.S. Kyprolis label. There was an increase in the incidence of renal adverse events of all grades observed in the Kyprolis arm compared to the active control arm and the label. "While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals.
News For AMGN From The Last 14 Days
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June 30, 2015
11:36 EDTAMGNRumor: Amgen moves up on speculation of an investor stake
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07:03 EDTAMGNCelgene leaps forward in immuno-oncology with Juno deal, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer said that Celgene (CELG) effectively spent $1B to buy into adoptive T cell therapy and own all of Juno Therapeutics' (JUNO) opportunities outside the U.S., leaping the company into a leading position in the immuno-oncology space. Schimmer additionally thinks Celgene's transaction should help boost investor confidence about the utility and value of CAR and TCR therapies, noting that he sees Bellicum Pharmaceuticals (BLCM), Cellectis (CLLS), Lion Biotechnologies (LBIO), bluebird bio (BLUE) and the Amgen (AMGN)-Kite Pharma (KITE) partnership as best positioned to compete in this rapidly advancing field. The analyst keeps an Overweight rating and $144 price target on Celgene.
June 24, 2015
07:56 EDTAMGNAmgen management to meet with Evercore ISI
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