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Carfilzomib-based combination improves multiple myeloma survival
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The ASPIRE trial met its key secondary endpoint of improved OS with the addition of carfilzomib to lenalidomide and dexamethasone, according to the agent’s manufacturer.
Final results from the phase 3 trial — which included 792 patients with relapsed multiple myeloma from North America, Europe and Israel — showed the addition of the proteasome inhibitor carfilzomib (Kyprolis, Amgen) to lenalidomide (Revlimid, Celgene) and dexamethasone conferred a 21% reduction in risk for death (median OS, 48.3 months vs. 40.4 months; HR = 0.79; 95% CI, 0.67-0.95).
“For multiple myeloma patients, the first relapse is usually the most devastating,” David S. Siegel, MD, PhD, chief of the division of multiple myeloma at John Theurer Cancer Center, said in a company-issued press release. “These data clearly show that the addition of Kyprolis — for just 18 cycles — to lenalidomide and dexamethasone at relapse gave patients a significantly improved chance of survival. With these results, this Kyprolis regimen should be considered a new standard of care.”
Toxicity appeared consistent with previously reported data. The most common adverse events observed among carfilzomib-treated patients included diarrhea, anemia, neutropenia, fatigue, upper respiratory tract infection, pyrexia, cough, hypokalemia, thrombocytopenia, muscle spasms, pneumonia, nasopharyngitis, nausea, constipation, insomnia and bronchitis.
ASPIRE is the second phase 3 trial to show a survival benefit in this setting with carfilzomib.
Amgen announced OS results from the phase 3 ENDEAVOR trial, which showed the addition of carfilzomib to bortezomib (Velcade, Takeda Oncology) and dexamethasone conferred a 21% reduction in mortality risk among patients with relapsed multiple myeloma (median OS, 47.6 months vs. 40 months; HR = 0.79; 95% CI, 0.65-0.96).
“The ENDEAVOR study has already demonstrated that Kyprolis is the superior proteasome inhibitor vs. Velcade,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “This overall survival benefit from the ASPIRE trial further supports the importance of proteasome inhibition and duration of treatment with Kyprolis in the treatment of relapsed multiple myeloma.”
The ASPIRE OS data will be submitted for presentation at a future medical conference, according to the release. The drug combination used in the study is FDA approved.