Carfilzomib Effective at Treating Relapsed Multiple Myeloma
the Cancer Therapy Advisor take:
Researchers of the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) study announced positive efficacy and safety results of the combination of carfilzomib and lenalidomide for patients with relapsed multiple myeloma.
The study reached its primary endpoint of progression-free survival when patients treated with carfilzomib, lenalidomide, and low-dose dexamethasone lived nearly nine months longer without disease progression compared to those only treated with lenalidomide and dexamethasone. The study's secondary endpoint, overall survival, is not yet ready for analysis, but seems to show no statistical significance.
The safety profile of carfilzomib, a proteasome inhibitor, appears to be consistent with the already marketed Kyprolis® (carfilzomib) used to treat mutliple myeloma in those who have received at least two prior therapies, including bortezomib and an immunomodulatory agent. Those adverse effects include: fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. The rate of cardiac adverse reactions, such as heart failure and heart attacks, were also similar.
Results of the ASPIRE study will be presented at the American Society of Hematology annual meeting in December 2014, and Amgen will pursue FDA approval in the first half of 2015.
Positive efficacy and safety results of the combination of carfilzomib and lenalidomide.
Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) met its primary endpoint of progression-free survival (PFS). Patients treated with Kyprolis® (carfilzomib) for Injection in combination with Revlimid® (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening (median 26.3 months) compared to patients treated with Revlimid and low-dose dexamethasone (Rd) (median 17.6 months) (HR=0.690, 95 percent CI, 0.570, 0.834, p<0.0001). While the data for overall survival, a secondary endpoint, are not yet mature, the analysis showed a trend in favor of KRd that did not reach statistical significance.
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