A post-hoc analysis of the phase 3 ASPIRE study indicates that treatment combining carfilzomib with lenalidomide and dexamethasone (KRd arm) extended the time patients with multiple myeloma live. Cumulative rates of complete response increased over time, particularly in the first 15 months of therapy, the data indicate. Risk of death, or progression, was estimated to be reduced by 42% during the 18-month treatment window. Progression-free survival hazard ratio was 0.58 (95% CI, 0.46-0.72) at 18 months. An analysis based on cytogenetic risk status indicated a significant improvement in progression-free survival for those treated with carfilzomib compared with lenalidomide and dexamethasone alone.1
Neutropenia (34.2%), anemia (25.5%), thrombocytopenia (22.4%), and fatigue (22.4%) were the most common adverse effects recorded in the ASPIRE trial.
In addition, data from the separate phase 3 ENDEAVOR trial indicate that patients with multiple myeloma treated with carfilzomib plus dexamethasone had improved progression-free survival compared with those patients receiving a combination of bortezomib plus dexamethasone. Treatment with carfilzomib plus dexamethasone also achieved superior progression-free survival, compared with treatment with subcutaneous bortezomib alone.
Carfilzomib (Kyprolis) is currently approved in the United States for use in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma. Results from this analysis were presented at the 21st Congress of the European Hematology Association (EHA).
1. Amgen. New analyses from pivotal phase 3 studies show Kyprolis® (carfilzomib) allows patients with relapsed multiple myeloma to live longer without disease progression [press release]. PR Newswire Web site. http://www.prnewswire.com/news-releases/new-analyses-from-pivotal-phase-3-studies-show-kyprolis-carfilzomib-allows-patients-with-relapsed-multiple-myeloma-to-live-longer-without-disease-progression-300283159.html. Posted June 10, 2016. Accessed June 14, 2016.