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news.Ortho Biotech, the biopharmaceutical division of Janssen- Cilag, has announced positive results from a registration-enabling Phase III trial evaluating the Velcade-based therapy with melphalan and prednisone compared with melphalan and prednisone alone, for previously untreated patients with multiple myeloma who are not eligible for stem cell transplantation.
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The study showed Velcade-based therapy with melphalan and prednisone (VMP) achieves superior complete response rates which are significantly durable and may be prolonged with continued therapy after the initial complete response is achieved. The three-year survival rate was 72% with VMP, versus 59% with MP, resulting in a 36% reduced risk of death.
The primary endpoint of the randomized, international, open-label Phase III Vista study was time-to-progression, with secondary endpoints including: response rates, time to and duration of response, progression free and overall survival, safety, and clinical benefit by time to next therapy.
Of 682 randomized patients (VMP=344, MP=338) who received up to 54 weeks of treatment – overall response rate was 71% with VMP versus 35% with MP (p<10-6); complete response rate (CR) with VMP was 30% compared to four percent CR; median time to response was 1.4 months with VMP compared to 4.2 months with MP (p<10-10); median time to CR was 4.2 months with VMP compared to 5.3 months with MP (p<10-10). For patients achieving CR the median duration of response was 24 months with VMP compared to 12.8 months for MP, allowing patients a greater opportunity for a treatment-free interval. Median time-to-progression was 24 months with VMP, compared to 16.6 months with MP (p=0.0000001), resulting in a 52% reduced risk of progression. Safety and tolerability were consistent with known VELCADE, melphalan and prednisone profiles Jesus San Miguel, principal investigator for the trial, said: "Velcade continues to demonstrate value as a standard of care that can slow or halt the progression of multiple myeloma across all stages of the disease, especially in previously untreated patients."