by Dr. C.H. Weaver M.D. updated 3/2019
Kyprolis Approved for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved Kyprolis™ (carfilzomib) for the treatment of patients with multiple myeloma that has already been treated with at least two prior therapies—including Velcade® (bortezomib) and a drug such as thalidomide or lenalidomide—and that has worsened within 60 days of the last treatment.
Kyprolis is a type of targeted drug known as a proteasome inhibitor. The approval of Kyprolis was based in part on a study of 266 people with relapsed, previously treated multiple myeloma. Study participants received up to 12 cycles of treatment with Kyprolis.
Overall, 23% of patients responded to treatment (had a reduction in detectable myeloma). One patient had a complete response (a disappearance of detectable myeloma). The median duration of these responses was 7.8 months.
The most common side effects of Kyprolis are fatigue, anemia, nausea, low platelet counts, shortness of breath, diarrhea, and fever. Some patients experience serious side effects, including heart failure.
Kyprolis is already approved as a single-agent for the treatment of patients with multiple myeloma who have received at least one prior therapy; or in combination with Revlimid (lenalidomide) plus dexamethasone for patients with recurrent multiple myeloma who have received one to three prior treatment strategies. Now, Kyprolis is approved for use in combination with dexamethasone for patients with recurrent multiple myeloma who have received one to three prior treatments.
The new approval is based upon results from the phase III trial referred to as the ENDEAVOR study. The trial included 929 patients who had received one to three prior therapies, but had experienced a recurrence of their disease. Patients were treated with either Kyprolis plus dexamethasone, or Velcade (bortezomib)—another proteasome inhibitor approved for multiple myeloma—plus low-dose dexamethasone.
- The median progression-free survival (time from initiation of treatment until disease progression or death) was approximately 18.7 months for patients treated with Kyprolis/dexamethasone, compared with only 9.4 months for patients treated with bortezomib/dexamethasone.
- Overall, the tolerability of Kyprolis/dexamethasone was comparable to that of bortezomib/dexamethasone.
- Overall anti-cancer responses occurred in 77% of patients treated with Kyrpolis/dexamethasone and 63% of patients treated with bortezomib/dexamethasone.
- Survival data are not yet mature enough to determine any differences in treatment regimens; however, this data will be updated upon maturity.
Reference: Amgen press release. FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma. Available at: . Accessed January 22, 2016.
The results from a planned interim analysis of the Phase 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis® (carfilzomib in combination with low-dose dexamethasone versus Velcade®(bortezomib) and low-dose dexamethasone have demonstrated that the Kyprolis® treated patients lived twice as long without their disease worsening.
The ENDEAVOR study is the first of two head-to-head studies for Kyprolis versus Velcade, an established proteasome inhibitor, currently approved to treat multiple myeloma. The randomized ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial of 929 patients evaluated Kyprolis in combination with low-dose dexamethasone, versus Velcade with low-dose dexamethasone in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens. This study was conducted at 235 sites worldwide.
The results of the study reveled that patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening compared to Velcade. Kyprolis treated patients survived on average 18.7 months compared to only 9.4 months for those receiving Velcade.
The Kyprolis combination was also reported to have higher overall response rates and less neuropathy. Overall survival data are not yet mature and continue to be monitored. More mature data will be available at the American Society of Clinical Oncology 2015 Annual Meeting in late May.
Reference: Amgen. 2015*. Phase 3 Head-to-Head ENDEAVOR Study Demonstrates Superiority Of Kyprolis® (carfilzomib) Over Velcade® (bortezomib) In Patients With Relapsed Multiple Myeloma*. Mar. 1.
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