An interim analysis of the phase 3 CASTOR trial evaluating the efficacy and safety of daratumumab in combination with bortezomib and dexamethasone demonstrated that the regimen had superior progression-free survival compared with bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma.1

“These results suggest daratumumab could potentially be used in combination with standard therapy in patients with relapsed or refractory multiple myeloma,” said Peter F. Lebowitz, MD, PhD, Global Oncology Head, Janssen Research & Development.                              

Because the study achieved its primary endpoint, it will be stopped early per the Independent Data Monitoring Committee’s recommendation.

For the international, open-label, controlled study, researchers enrolled approximately 490 patients with relapsed or refractory multiple myeloma. Patients were randomly assigned to receive either daratumumab in combination with subcutaneous bortezomib and dexamethasone, or bortezomib and dexamethasone alone. Patients were treated until disease progression or unacceptable toxicity.

Daratumumab was administered at a dose of 16 mg/kg intravenously weekly for the first 3 cycles, on day 1 of cycles 4 to 9, and then every 4 weeks thereafter. Patients in both arms received bortezomib 1.3 mg/m2 subcutaneously on days 1, 4, 8, and 11 of each 21-day cycle for 8 cycles and dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 for 8 cycles.

The results, which showed that the immunotherapy combination improved progression-free survival compared with bortezomib and dexamethasone alone (P < .0001), will be submitted for presentation at an upcoming medical congress and for publication in a peer-reviewed journal.

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Daratumumab, a human CD38-directed monoclonal antibody, was initially approved by the U.S. Food and Drug Administration in 2015. It is indicated for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

Reference

  1. First phase 3 trial of daratumumab in combination with standard therapy in relapsed/refractory multiple myeloma meets primary endpoint in planned interim analysis [news release]. Raritan, NJ: Janssen; March 30, 2016. http://janssen.com/first-phase-3-trial-daratumumab-combination-standard-therapy-relapsedrefractory-multiple-myeloma. Accessed April 1, 2016.

An interim analysis of the phase 3 CASTOR trial evaluatingthe efficacy and safety of daratumumab in combination with bortezomib anddexamethasone demonstrated that the regimen had superior progression-freesurvival compared with bortezomib and dexamethasone alone in patients withrelapsed or refractory multiple myeloma.1

 

“These results suggest daratumumab could potentially be usedin combination with standard therapy in patients with relapsed or refractorymultiple myeloma,” said Peter F. Lebowitz, MD, PhD, Global Oncology Head,Janssen Research & Development.

                                   

Because the study achieved its primary endpoint, it will bestopped early per the Independent Data Monitoring Committee’s recommendation.

 

For the international, open-label, controlled study,researchers enrolled approximately 490 patients with relapsed or refractorymultiple myeloma. Patients were randomly assigned to receive either daratumumabin combination with subcutaneous bortezomib and dexamethasone, or bortezomiband dexamethasone alone. Patients were treated until disease progression orunacceptable toxicity.

 

Daratumumab was administered at a dose of 16 mg/kgintravenously weekly for the first 3 cycles, on day 1 of cycles 4 to 9, andthen every 4 weeks thereafter. Patients in both arms received bortezomib 1.3mg/m2 subcutaneously on days 1, 4, 8, and 11 of each 21-day cycle for8 cycles and dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12for 8 cycles.

 

The results, which showed that the immunotherapy combinationimproved progression-free survival compared with bortezomib and dexamethasonealone (P < .0001), will besubmitted for presentation at an upcoming medical congress and for publicationin a peer-reviewed journal.

 

Daratumumab, a human CD38-directed monoclonal antibody, wasinitially approved by the U.S. Food and Drug Administration in 2015. It isindicated for the treatment of patients with multiple myeloma who have receivedat least 3 prior lines of therapy including a proteasome inhibitor and animmunomodulatory agent or who are double-refractory to a proteasome inhibitorand an immunomodulatory agent.

 

Reference

First phase 3 trial of daratumumab incombination with standard therapy in relapsed/refractory multiple myeloma meetsprimary endpoint in planned interim analysis [news release]. Raritan, NJ:Janssen; March 30, 2016. http://janssen.com/first-phase-3-trial-daratumumab-combination-standard-therapy-relapsedrefractory-multiple-myeloma.Accessed April 1, 2016