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Amgen Announces Top-Line Results From Phase 3 Focus Trial Of Kyprolis® In Patients With Relapsed And Advanced Refractory Multiple Myeloma

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Aug. 13, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that the Phase 3 clinical trial FOCUS (Car Filz Omib for Advan Ced Refractory M Ultiple Myeloma European Study) did not meet its primary endpoint of improving overall survival (OS) (HR=0.975, 95 percent CI, 0.760, 1.249). 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, Inc.

Detailed results will be submitted for presentation at an upcoming scientific meeting.

About FOCUSThe randomized, open-label Phase 3 FOCUS (Car Filz Omib for Advan Ced Refractory M Ultiple Myeloma European Study) trial evaluated single-agent Kyprolis versus an active control regimen of low-dose steroids plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma following treatment with at least three prior therapies. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, overall response rate, clinical benefit rate, duration of response and safety. Patients were randomized to receive Kyprolis (20mg/m 2 on days 1 and 2 of cycle 1 followed by 27mg/m 2 on days 8, 9, 15, and 16 of cycle 1 and all doses cycle 2 through 9, and 27 mg/m 2 on days 1,2,15, and 16 of cycle 10 and beyond) or an active control regimen of oral steroids and optional cyclophosphamide. The trial enrolled 315 patients.

About Multiple MyelomaMultiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the U.S., approximately 70,000 people are living with multiple myeloma and approximately 24,000 new cases are diagnosed annually.[1] Worldwide, nearly 230,000 people are living with multiple myeloma and approximately 114,000 new cases are diagnosed annually.[2] In Europe, approximately 89,000 people are living with multiple myeloma, and approximately 39,000 new cases are diagnosed annually.[3]

About Kyprolis ® (carfilzomib) for InjectionOn July 20, 2012, the FDA granted accelerated approval of Kyprolis ® (carfilzomib) for Injection for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

Kyprolis is marketed in the U.S. by Onyx Pharmaceuticals, Inc., an Amgen subsidiary.

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