Amgen showcases positive Phase III multiple myeloma drug at ASCO

pharmafile | June 7, 2016 | News story | Manufacturing and Production, Research and Development ASCO, Amgen, Kyprolis, dexamethasone, lenalidomide, multiple myeloma 

Amgen (NASDAQ: AMGN) has presented data showing a statistically significant increase in progression-free survival and overall response rate in multiple myeloma patients treated with Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone.

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. It is a rare and very aggressive disease that accounts for approximately one percent of all cancers.

Kyprolis works by causing cell death in myeloma cells as it has been shown to block proteasomes, which play an important role in breaking down proteins that are damaged or no longer needed. It has been approved in this indication in the US and in Europe.

The results of the ASPIRE Phase III trial were presented at the American Society of Clinical Oncology’s annual congress. In the trial, Kyprolis plus lenalidomide and dexamethasone (KRd) was compared to treatment with the latter two (Rd), alone.

Of patients who relapsed within one year of initial therapy and treated with KRd experienced a median progression-free survival rate of 24.1 months versus 12.5 months in those treated with Rd. Additionally, overall response rate was 79.3% for the Kyprolis combo, compared to 61.1% for the Rd patients. Similar positive results were found in progression-free survival in patients relapsing early after first prior transplant. Those treated with KRd experienced a median progression-free survival rate of 17.3 months compared to 11.1 months.

Sean E. Harper, executive VP of R&D at Amgen, comments: “A goal in treating relapsed multiple myeloma is to get patients into remission, and keep them in remission as long as possible. For some patients who relapse early, this may be a sign of a more aggressive disease. This analysis showed that in early relapsing multiple myeloma patients, the addition of Kyprolis to lenalidomide and dexamethasone resulted in patients living longer without their disease progressing, a significant milestone for patients living with this difficult-to-treat disease.”

Kyprolis received an accelerated assessment from the European Medicines Agency (EMA), and  orphan drug designation in 2008, given to medicines intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of no more than five in 10,000 people.

Sean Murray

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