ARROW Trial: Multiple Myeloma Patients Have Longer PFS With Kyprolis Once-Weekly Regimen

Results of the Phase 3 ARROW trial revealed that patiehts with refractory multiple myeloma can live up to 3.6 months longer, without their disease worsening, when Kyprolis (carfilzomib) is administered once-weekly at the 70 mg/m² dose with dexamethasone rather than Kyprolis administered twice-weekly at the 27 mg/m² dose with dexamethasone, according to Amgen.

The study consisted of 478 patients with relapsed and refractory multiple myeloma who have received 2 or 3 prior lines of therapy—this includes a proteasome inhibitor and an immunomodulatory agent (IMiD). The patients were treated with once-weekly Kyprolis regimen and had achieved a statistically significant superior progression-free survival (PFS) with a median of 11.2 months while those who were treated with the twice-weekly regimen had a median PFS of 7.6 months.

"Kyprolis has been demonstrated to be the most effective proteosome inhibitor available to patients with multiple myeloma," Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a statement. "We are encouraged by the efficacy and safety profile of Kyprolis and dexamethasone administered once-weekly in the ARROW study."

In August, Kyprolis had been accepted by the FDA for review as a supplemental New Drug Application based on the overall survival (OS) data from the Phase 3 ENDEAVOR trial that revealed Kyprolis and dexamethasone can reduce the risk of death by 21% and increase OS by 7.6 months compared to Velcade.

"These data, along with compelling overall survival results from the phase 3 ASPIRE trial, clearly demonstrate that Kyprolis-based regimens should be considered new standards of care for appropriate patients with relapsed multiple myeloma,” said Harper in August.

The new once-weekly KYPROLIS regimen was also found to have an overall safety profile that was comparable to the twice-weekly regimen. However, the most frequently reported treatment emergent adverse events were in either treatment arm anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.