Amgen presents new data on Kyprolis in multiple myeloma
Posted: 7 December 2015 | | No comments yet
The data showed Kyprolis in combination with dexamethasone significantly extended disease progression compared to bortezomib plus dexamethasone…
Amgen has presented new key data evaluating Kyprolis (carfilzomib) -based regimens in patients with relapsed multiple myeloma.
The data, presented during the 57th Annual Meeting and Exposition of the American Society of Haematology (ASH), showed Kyprolis in combination with dexamethasone significantly extended disease progression compared to bortezomib plus dexamethasone across a range of difficult-to-treat populations, specifically those with high risk and previously treated disease.
Data analyzed in three presentations across patient subgroups from the Phase 3 ENDEAVOR trial showed that patients with relapsed or refractory multiple myeloma, who were treated with Kyprolis plus dexamethasone, achieved superior progression-free survival (PFS) compared to those receiving bortezomib plus dexamethasone. The subgroup analyses evaluated the Kyprolis combination based on prior treatment, cytogenetic risk status and age, respectively.
Kyprolis shown to improve progression-free survival
A separate presentation analysed the efficacy and safety of the therapy according to baseline cytogenetic risk status, based on data from the Phase 3 ASPIRE trial in which Kyprolis in combination with lenalidomide and dexamethasone demonstrated a significant improvement in PFS compared to lenalidomide and dexamethasone.
“Our clinical research with Kyprolis aims to improve outcomes for patients in the relapsed setting, which are currently poor due to more aggressive disease biology as multiple myeloma progresses,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “This week’s presentations show that even in difficult-to-treat populations, Kyprolis significantly extends the time patients can live without their disease progressing and improves the depth and duration of a response, compared to current standard of care therapies.”
Kyprolis received approval from the US Food and Drug Administration (FDA) in July 2015 for combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.
The therapy is also indicated under FDA accelerated approval in July 2012 as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Last month, the European Commission granted marketing authorisation for Kyprolis in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Amgen has since submitted an application to expand the indication of Kyprolis to be used in combination with dexamethasone alone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.