Spectrum Pharmaceuticals, makers of the radioimmunotherapy treatment Zevalin, have announced the initiation of a Phase III clinical trial of Zevalin in patients over the age of 60 who have been diagnosed with diffuse large B-cell lymphoma (DLBCL).
The so-called ZEST trial will have as its primary end point overall survival.
The ZEST trial will test the efficacy of the Zevalin therapeutic regimen against the current gold standard in diffuse large B-cell lymphoma, R-CHOP combination chemotherapy.
In prior Phase II trials, when Zevalin was given to DLBCL patients as consolidation therapy following R-CHOP, it showed a 5-year overall survival rate of 84% and a 5-year progression-free survival rate of 75%.
In fact, adding Zevalin after R-CHOP actually boosted overall survival in DLBCL patients by 15% compared to those patients who received R-CHOP and no consolidation therapy.
Currently, Zevalin is approved for a specific subset of patients with indolent non-Hodgkin's lymphomas. A successful Phase III trial could win the company marketing approval for Zevalin as therapy against more aggressive B-cell lymphomas.