Results of the phase 3 clinical trial ASPIRE were presented at the American Society of Hematology Meetings this week. Relapsed multiple myeloma 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.1 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.
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. Patients with relapsed or refractory myeloma were treated with either Kyprolis® Revlimid ® and low-dose dexamethasone or a standard regimen of Revlimid ® and low-dose dexamethasone and directly compared.
Overall 792 relapsed or refractory patients from 20 countries who had been treated with one to three prior regimens enrolled in the trial. The objective response rate was significantly higher 87% vs 67%, and the rate of complete responses was more than three times higher for the Kyprolis® regimen: 32% vs 9%. 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. Despite the addition of Kyprolis®, toxicity was not significantly increased in that arm. Patients receiving Kyprolis®actually had higher health-related quality of-life scores
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.
- 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.
- Stewart K, Rajkumar V, Dimopoulos M, et al. Carfilzomib, Lenalidomide, and Dexamethasone vs Lenalidomide and Dexamethasone in Patients (Pts) with Relapsed Multiple Myeloma: Interim Results from ASPIRE, a Randomized, Open-Label, Multicenter Phase 3 Study. Presented at the 56th Annual Meeting of the American Society of Hematology, December 6-9, 2014. Abstract 79.
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