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Amgen has announced positive results from the final analysis of the phase 3 ASPIRE trial. The study met the key secondary endpoint of overall survival (OS), demonstrating that Kyprolis (carfilzomib), lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 per cent over lenalidomide and dexamethasone alone (Rd) (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 per cent CI, 0.67 – 0.95). Per protocol, patients received 18 cycles of Kyprolis with Rd before continuing treatment with Rd alone to progression. This KRd regimen of twice-weekly Kyprolis administered at 27 mg/m2 is currently approved in the US, European Union and other countries based on the primary analysis of progression-free survival (PFS) in the ASPIRE study.
"For multiple myeloma patients, the first relapse is usually the most devastating," said David S. Siegel, M.D., Ph.D., chief of the Division of Multiple Myeloma at John Theurer Cancer Center in Hackensack, N.J., and investigator on the ASPIRE trial. "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."
"The ENDEAVOR study has already demonstrated that Kyprolis is the superior proteasome inhibitor versus Velcade," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "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."
Adverse events observed in this updated analysis were consistent with those previously reported for ASPIRE. The most common adverse events (greater than or equal to 20 percent) in the Kyprolis arm were diarrhea, anemia, neutropenia, fatigue, upper respiratory tract infection, pyrexia, cough, hypokalemia, thrombocytopenia, muscle spasms, pneumonia, nasopharyngitis, nausea, constipation, insomnia and bronchitis.
Amgen recently announced OS results from the phase 3 head-to-head ENDEAVOR trial, which showed Kyprolis at 56 mg/m2 in combination with dexamethasone reduced the risk of death by 21 per cent over Velcade (bortezomib) and dexamethasone (Vd). Patients treated with Kyprolis lived 7.6 months longer than those treated with Velcade (median OS 47.6 months for Kd versus 40.0 months for Vd, HR = 0.79, 95 per cent CI, 0.65 – 0.96).
The ASPIRE OS data will be submitted to a future medical conference, for publication, and to regulatory agencies worldwide to support a potential label update.
The Kyprolis clinical programme continues to focus on providing solutions for physicians and patients in treating this frequently relapsing and difficult-to-treat cancer. Kyprolis is available for patients whose myeloma has relapsed or become resistant to another treatment and continues to be studied in a range of combinations and patient populations.
Amgen's phase, relapsed multiple myeloma meets key, secondary endpoint
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