Amgen said Tuesday that in a Phase III study of patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant, Kyprolis (carfilzomib) failed to demonstrate superiority in progression-free survival (PFS) versus Takeda's Velcade (bortezomib). Top-line results from the CLARION trial showed that for the primary endpoint, PFS for the two drugs was 22.3 months and 22.1 months, respectively.
Sean E. Harper, executive vice president of R&D at Amgen, called the findings "disappointing," but explained that "the myeloma landscape has changed dramatically since the design of the CLARION study with very few newly diagnosed patients treated with melphalan-based regimens, particularly in the US."
In the study, 955 patients with newly diagnosed melanoma were randomised to treatment with Kyprolis or Velcade, both in combination with melphalan and prednisolone, for 54 weeks. Amgen noted that while data for the secondary endpoint of overall survival are not yet mature, there is no significant difference between the two treatment groups.
The company said that results from the study will be presented at a future research conference. The drugmaker added that it is supporting several investigator-sponsored studies of Kyprolis, including the Phase III ENDURANCE trial comparing Kyprolis and Velcade, both together with Celgene's Revlimid (lenalidomide) and dexamethasone, in patients with newly diagnosed multiple myeloma.
Kyprolis was initially authorised in the US for the treatment of multiple myeloma in patients whose disease progressed despite treatment with at least two prior therapies. The drug has since been approved in the US, EU and Canada in combination with Revlimid and dexamethasone for the treatment of patients with relapsed multiple myeloma who received at least one prior treatment.
Amgen obtained rights to Kyprolis as part of its $10-billion takeover of Onyx Pharmaceuticals in 2013. Sales of the drug for the first half of 2016 reached $326 million.
For related analysis, read ViewPoints: Amgen's Kyprolis fails to pull out of Velcade's slipstream when it matters.
To read more Top Story articles, click here.