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news.Cell Therapeutics has announced positive results of a Phase II clinical study, which demonstrated that the addition of radioimmunotherapy to high-dose chemotherapy followed by autologous stem-cell transplantation produced a high rate of progression-free survival at two years without a significant increase in the toxicity of the HDC regimen underscoring the potential role for RIT in ASCT.
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The trial evaluated the safety and efficacy of combining a standard dose of Zevalin followed by high-dose Beam and autologous stem-cell transplantation (ASCT) in patients with non-Hodgkin’s lymphoma who were considered ineligible for total-body irradiation because of older age or prior radiotherapy. Primary endpoints of the study were overall and progression-free survival. Secondary endpoints included safety and long-term complications.
The study, conducted at the City of Hope Comprehensive Cancer Center, used a single dose of Zevalin in patients undergoing ASCT following high-dose chemotherapy (HDC) with the Beam regimen (carmustine, cytarabine, etoposide, and melphalan). Thirty-seven of the 41 patients had failed prior rituximab therapy. Seven of the ten patients transplanted in partial remission (70%) converted to complete remissions following the Zevalin-based regimen. The addition of Zevalin to the Beam regimen did not appear to add to the toxicity of HDC; the day 100 mortality rate was zero percent. Importantly the two-year overall and progression-free survival estimates were approximately 89% and 70%.
Jack Singer, chief medical officer at Cell Therapeutics, said: “The promise of utilizing targeted radioimmunotherapy together with high-dose chemotherapy prior to autologous stem-cell transplant is an exciting new potential application of Zevalin. We expect to explore this as an additional registration direction for Zevalin.”