The big news yesterday evening was that Amgen’s phase III FOCUS trial in relapsed/refractory multiple myeloma failed to meet its primary endpoint of overall survival (HR=0.975).
Such a marginal hazard ratio (HR) tells us that the risk of death was not reduced by taking carfilzomib over best supportive care.
According to the company:
“The 315-patient, open-label study evaluated single-agent Kyprolis® (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. Nearly all patients in the control arm received cyclophosphamide. Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry.”
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This week Amgen announced that their second generation proteasome inhibitor, carfilzomib (Kyprolis), had met the primary endpoint of progression free survival (PFS) in the phase III ASPIRE trial. This study compared the triple combination of Kyprolis plus Revlimid and low dose dexamethasone (KRd) to the doublet of Revlimid plus low dose dexamethasone (Rd) in relapsed/refractory multiple myeloma. The overall survival (OS) is not yet mature and statistical significance was not been reached at the interim analysis. We will have to see how that data is looking in a few months time at the American Society of Hematology (ASH) meeting in December.
This is an important trial because the data will enable Amgen to file for approval of carfilzomib in Europe with the survival data. The PFS for the two groups (26.3 vs. 17.6 months) showed a clear benefit in favour of adding carfilzomib to standard therapy by 8.7 months:
“Results from the ASPIRE study will form the basis for regulatory submissions throughout the world beginning in the first half of 2015.”
Allowing time for CHMP approval and country reimbursement, this means that carfilzomib will possibly be available in 1H16 in Europe.
What impact will this data have on the multiple myeloma landscape?
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