Amgen's multiple myeloma drug meets phase III targets
- Amgen and its subsidiary, Onyx Pharmaceuticals, have publicized positive interim data from the ASPIRE study showing that multiple myeloma patients treated with Kyprolis combined with Revlimid (lenalomide) and low-dose dexamethasone gained an extra 8.7 months of progression-free survival, compared with Revlimid and dexamethasone alone.
- Results will be presented at the American Society of Hematology meeting later this year.
- Regulatory submissions for Kyprolis in the US and EU will occur during the first half of 2015.
Multiple myeloma is the second most common hematologic cancer. Currently, there are 70,000 people in the US and 230,000 people worldwide living with multiple myeloma. Each time a patient undergoes a treatment, the remission period is shortened, making new treatment options imperative to increasing progression-free survival (PFS).
The ASPIRE study showed the clinical benefit of Kyprolis in conjunction with other agents in extending PFS. As in previous studies, there were safety concerns related to an increased risk of cardiac arrest associated with this treatment regimen. But overall, patients in the Kyprolis arm of the study lived an average of 26.3 months, compared with 17.6 months among the control.