Snapshot of Kyprolis Trial Results That Led to FDA Approval of ONYX MM Drug

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Kyprolis - the new hope for multiple myeloma patients.

The final results of the clinical trials that led to the FDA approval of Kyprolis has been published in the journal, Blood. The results of the phase 2 study find that Kyprolis/carfilzomib is less toxic and effective in treating relapsed and refractory multiple myeloma patients. The US Food and Drug Administration recently approved Kyprolis based on the results of this study.

Kyprolis offers patients another option to Velcade. One that does not case neuropathy, and thus keeps patients free from pain and loss of sensation in the extremities.

Snapshot of Trial and Results

Trial was conducted from July 2008 to October 2009.Trial was conducted from July 2008 to October 2009.
Total number of participants was 266.
All participants had received a median of five prior therapies prior to enrolling for the study which included Velcade, Revlimid, or thalidomide.
All participants were refractory to the most recent therapy.
Participants received 20mg/m² of Kyprolis twice a week for three weeks. of Kyprolis twice a week for three weeks.
Subsequent treatment cycle had an increased dose of Kyprolis, 27mg/m² for 12 cycles.
Participants were administered 4mg dexamethasone prior to every dose of Kyprolis to prevent infusion reactions.
23% patients responded to Kyprolis.
0.4% showed complete response.
5% showed good partial response.
18% showed partial response.
Median response duration was 7.8 months.
Median progression-free survival time was 3.7 months.
Median overall survival time was 15.6 months.
Common side effects observed:
- Fatigue in 49%
- Low red blood cell counts in 46%
- Nausea in 45%
- Low platelet counts in 39%
There was drastic reduction in occurrence of peripheral neuropathy in patients after treatment with Kyprolis.

Results of this trial and other trials on Kyprolis indicate that Kyprolis is more effective in higher doses. The drug is being studied in combination with dexamethasone and Revlimid for refractory and relapsed multiple myeloma patients.