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Amgen’s Kyprolis Receives Expanded Approval for Multiple Myeloma Treatment

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European Medicines Agency (EMA) approved and extended the current indication of Amgen’s Kyprolis® (carfilzomib) for the treatment of relapsed multiple myeloma.

Amgen-Inc-logoWithin one year, this is the second approval of the drug which will allow the drug to be used in combination therapy with dexamethasone in the adult patients suffering from multiple myeloma who already received a prior therapy.

Amgen kyprolis logo

The drug has been given green light after a comparative Phase III pivotal head to head study of Kyprolis with the standard proteasome inhibitor of Takeda, Velcade® (bortezomib). The combinatorial effect of Kyprolis with dexamethasone doubled the patient’s progression free survival (PFS) and also increased the complete response rates compared to the patients administered with Velcade with dexamethasone.

bortezomib-structure

In the Phase III study, ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib plus DExamethAsone Vs Bortezomib plus Dexamethas One study in Patients with Relapsed Multiple Myeloma). The comparative study was conducted in 929 multiple myeloma patients who had at least one relapse after their previous therapy. They were given low dose of Kyprolis and dexamethasone and studies against bortezomib with low-dose dexamethasone. The trial was conducted in two arms and in 235 sites worldwide making it a one of a kind, large clinical trial studies.

The results indicated higher PFS rate of 18.7 months in the patients who were given combination of Kyprolis with dexamethasone compared to 9.4 months in patients receiving Velcade® (bortezomib) in combination with dexamethasone.

The overall response rate evaluation of Kyprolis®  and dexamethasone  were observed to be higher (76.9%) than Velcade and dexamethasone and  the tolerability of both arms were found to be similar.

Proteasomes play key role in cell growth and function by waste protein breakdown. Kyprolis® (carfilzomib) can block proteasomes and lead to excessive accumulation of protein inside the cells. Kyprolis can also cause cell death specifically in myeloma cells as they contain large amount of abnormal protein.

carfilzomib proteosome inhibitor

Figure 1. Molecular mechanism of carfilzomib (photo credit: Blood 2013 121:893-897; doi:10.1182/blood-2012-10-459883).

In 2015, Kyprolis was first approved by EC to be used as a combination therapy with lenalidomide and dexamethasone for treatment of patients with multiple myeloma.

myeloma mechanism

Figure 2. Multiple myeloma (photo credit: medichere.com).

Multiple Myeloma is a rare, severe form of blood cancer and is incurable. The drug is given orphan status and is primarily characterized by repeated pattern of remission and relapse. This cancer accounts for one percent of cancer worldwide.

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen said, “Kyprolis-based regimens have now shown superiority over two former standard-of-care treatment options for relapsed multiple myeloma patients, reinforcing Kyprolis’ place as a foundational therapy in this patient population“.

Featured image credit: 3d rendered, medically accurate 3d illustration of a tumor © Eraxion (Stock Photo ID: 135149729)

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