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Top-line results from the phase 3 CLARION trial suggest that treatment with carfilzomib, melphalan, and prednisone (KMP) is not superior to treatment with bortezomib, melphalan, and prednisone (VMP).
The trial was designed to compare KMP and VMP in patients with newly diagnosed multiple myeloma (MM) who were ineligible for hematopoietic stem cell transplant.
The results showed that progression-free survival (PFS) rates were similar with the 2 regimens.
And although overall survival data are not yet mature, there seems to be a trend favoring the VMP regimen.
Amgen, the company developing carfilzomib, released these results yesterday.
“The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we’ve seen in the second-line setting,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.
“However, 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. We remain committed to exploring Kyprolis in combination with other agents to advance the treatment of multiple myeloma.”
Dr Harper said he could not comment on whether the CLARION trial will continue, as Amgen hopes to present data from the trial at the 2016 ASH Annual Meeting.
The CLARION trial is a head-to-head, randomized study in transplant-ineligible patients with newly diagnosed MM. A total of 955 patients were randomized 1:1 to receive KMP or VMP for 54 weeks. The median patient age was 72.
The trial did not meet the primary endpoint of superiority in PFS. The median PFS was 22.3 months in the KMP arm and 22.1 months in the VMP arm. The hazard ratio was 0.91 (95% CI, 0.75-1.10), and the difference between the arms was not statistically significant.
The data for overall survival, a secondary endpoint, are not yet mature. But the observed hazard ratio was 1.21 (95% CI, 0.90-1.64), and there was no significant difference between the treatment arms.
The incidence of grade 3 or higher adverse events was 74.7% in the KMP arm and 76.2% in the VMP arm.
The incidence of grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5% in the KMP arm and 35.1% in the VMP arm.
Fatal treatment-emergent adverse events occurred in 6.5% of patients in the KMP arm and 4.3% of those in the VMP arm. 
Top-line results from the phase 3 CLARION trial suggest that treatment with carfilzomib, melphalan, and prednisone (KMP) is not superior to treatment with bortezomib, melphalan, and prednisone (VMP).
The trial was designed to compare KMP and VMP in patients with newly diagnosed multiple myeloma (MM) who were ineligible for hematopoietic stem cell transplant.
The results showed that progression-free survival (PFS) rates were similar with the 2 regimens.
And although overall survival data are not yet mature, there seems to be a trend favoring the VMP regimen.
Amgen, the company developing carfilzomib, released these results yesterday.
“The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we’ve seen in the second-line setting,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.
“However, 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. We remain committed to exploring Kyprolis in combination with other agents to advance the treatment of multiple myeloma.”
Dr Harper said he could not comment on whether the CLARION trial will continue, as Amgen hopes to present data from the trial at the 2016 ASH Annual Meeting.
The CLARION trial is a head-to-head, randomized study in transplant-ineligible patients with newly diagnosed MM. A total of 955 patients were randomized 1:1 to receive KMP or VMP for 54 weeks. The median patient age was 72.
The trial did not meet the primary endpoint of superiority in PFS. The median PFS was 22.3 months in the KMP arm and 22.1 months in the VMP arm. The hazard ratio was 0.91 (95% CI, 0.75-1.10), and the difference between the arms was not statistically significant.
The data for overall survival, a secondary endpoint, are not yet mature. But the observed hazard ratio was 1.21 (95% CI, 0.90-1.64), and there was no significant difference between the treatment arms.
The incidence of grade 3 or higher adverse events was 74.7% in the KMP arm and 76.2% in the VMP arm.
The incidence of grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5% in the KMP arm and 35.1% in the VMP arm.
Fatal treatment-emergent adverse events occurred in 6.5% of patients in the KMP arm and 4.3% of those in the VMP arm.
Top-line results from the phase 3 CLARION trial suggest that treatment with carfilzomib, melphalan, and prednisone (KMP) is not superior to treatment with bortezomib, melphalan, and prednisone (VMP).
The trial was designed to compare KMP and VMP in patients with newly diagnosed multiple myeloma (MM) who were ineligible for hematopoietic stem cell transplant.
The results showed that progression-free survival (PFS) rates were similar with the 2 regimens.
And although overall survival data are not yet mature, there seems to be a trend favoring the VMP regimen.
Amgen, the company developing carfilzomib, released these results yesterday.
“The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we’ve seen in the second-line setting,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.
“However, 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. We remain committed to exploring Kyprolis in combination with other agents to advance the treatment of multiple myeloma.”
Dr Harper said he could not comment on whether the CLARION trial will continue, as Amgen hopes to present data from the trial at the 2016 ASH Annual Meeting.
The CLARION trial is a head-to-head, randomized study in transplant-ineligible patients with newly diagnosed MM. A total of 955 patients were randomized 1:1 to receive KMP or VMP for 54 weeks. The median patient age was 72.
The trial did not meet the primary endpoint of superiority in PFS. The median PFS was 22.3 months in the KMP arm and 22.1 months in the VMP arm. The hazard ratio was 0.91 (95% CI, 0.75-1.10), and the difference between the arms was not statistically significant.
The data for overall survival, a secondary endpoint, are not yet mature. But the observed hazard ratio was 1.21 (95% CI, 0.90-1.64), and there was no significant difference between the treatment arms.
The incidence of grade 3 or higher adverse events was 74.7% in the KMP arm and 76.2% in the VMP arm.
The incidence of grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5% in the KMP arm and 35.1% in the VMP arm.
Fatal treatment-emergent adverse events occurred in 6.5% of patients in the KMP arm and 4.3% of those in the VMP arm.