Amgen announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE met its primary endpoint of progression-free survival (PFS). Patients treated with Kyprolis® (carfilzomib) in combination with Revlimid® (lenalidomide) and low-dose dexamethasone lived significantly longer without their disease worsening compared to patients treated with Revlimid and low-dose dexamethasone.
Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. In the U.S., approximately 70,000 people are living with multiple myeloma and approximately 24,000 new individuals are diagnosed annually. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine. Patients with multiple myeloma who have become refractory—or resistant—to the drugs Revlimid and Velcade® (bortezomib) have limited treatment options. There is no standard treatment for these patients and they typically have a poor prognosis.
Kyprolis belongs to a class of drugs known as proteasome inhibitors. They work by preventing the breakdown of protein in cancer cells, triggering their death. Researchers have previously reported the results of a study that included 52 patients with relapsed progressive multiple myeloma treated with Kyprolis, Revlimid, and dexamethasone 40 mg once weekly on 28-day cycles. Kyprolis, Revlimid, and low-dose dexamethasone was “well tolerated with durable responses even in patients refractory to Velcade and Revlimid.” Now the ASPIRE clinical trial has confirmed these initial observations. Patients treated with Kyprolis in combination with Revlimid and low-dose dexamethasone lived on average 26.3 months without their disease worsening compared to 17.6 months for patients treated with Revlimid and low-dose dexamethasone.
About ASPIRE The international, randomized Phase 3 ASPIRE (CArfilzomib, Revlimid, and DexamethaSone versus Revlimid and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial evaluated Kyprolis in combination with Revlimid and low-dose dexamethasone, versus Revlimid and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens. The primary endpoint of the trial was progression-free survival, defined as the time from treatment initiation to disease progression or death. Secondary endpoints included overall survival, overall response rate, duration of response, disease control rate, health-related quality of life, and safety. Patients were randomized to receive Kyprolis ® (2 on days 1 and 2 of cycle 1 only, then 27mg/m2 subsequently), in addition to a standard dosing schedule of Revlimid ® (25mg per day for 21 days on, 7 days off) and low-dose dexamethasone (40mg per week in 4 week cycles), versus Revlimid ® and low-dose dexamethasone alone. The study randomized 792 patients at sites in North America, Europe, and Israel.
Results from the ASPIRE study will form the basis for Kyprolis regulatory submissions throughout the world beginning in the first half of 2015. In the U.S., the data may support the conversion of accelerated approval to full approval and expand the current indication. Results from the ASPIRE study will be submitted for presentation at the upcoming 56th Annual Meeting of the American Society of Hematology later this year.
**Reference:**Wang M, Martin T, Bensinger W, et al. Phase 2 dose-expansion study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma. Blood. 2013; 122(18):3122-3128.
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