Carfilzomib Represents Potent, Effective Addition to Standard Multiple Myeloma Therapy in Phase III Study

Carfilzomib, Lenalidomide, and Dexamethasone vs. Lenalidomide and Dexamethasone in Patients (Pts) with Relapsed Multiple Myeloma: Interim Results from ASPIRE, a Randomized, Open-Label, Multicenter Phase III Study

The recently approved targeted treatment carfilzomib has been shown to help slow or halt the spread of cancer by targeting the mechanisms that control excess proteins on which multiple myeloma cells thrive for continued growth. Carfilzomib adds to an increasing number of precision approaches that are shifting the treatment paradigm away from chemotherapy. In fact, the current global standard of care for patients with relapsed or treatment-resistant multiple myeloma is a combination of a drug called lenalidomide that specifically targets the immune system and the steroid dexamethasone.

In order to evaluate whether carfilzomib combined with standard therapy might improve treatment responses in patients with relapsed or treatment-resistant multiple myeloma, researchers enrolled 792 patients from 20 countries in a Phase III clinical trial, randomizing them to receive the standard combination of lenalidomide and dexamethasone (Rd) or the combination along with carfilzomib (KRd). Upon interim analysis, the group treated with KRd demonstrated a longer duration of response without disease progression (26.3 months) compared with the Rd-treated group (17.6 months). The difference in overall response rates in the two treatment groups was also significant, at 87.4 percent in the KRd group compared to 66.9 percent in the Rd group. Importantly, despite the addition of a drug to the regimen, no dramatic increase in toxicity was observed in the KRd group. In addition, patients in the KRd group consistently reported higher quality of life scores than those receiving Rd.

“By adding carfilzomib to the gold standard in multiple myeloma therapy, we are observing an unprecedented duration of remission without additional toxicity, a promising outcome in relapsed and heavily pre-treated patients,” said lead study author A. Keith Stewart, MD, of Mayo Clinic Arizona in Scottsdale. “We hope that the results of this trial will lead to approval of this treatment combination in patients with relapsed multiple myeloma worldwide.”