Millennium Pharmaceuticals Inc announced that in the final survival endpoint analysis in the phase III confirmatory APEX study comparing patients receiving Velcade to those receiving high-dose dexamethasone, Velcade produced a statistically significant survival benefit.
The study was designed to include survival as a secondary endpoint and allowed crossover for patients experiencing disease progression on high-dose dexamethasone to receive Velcade. Both the interim data and the final survival analysis from the APEX study will be presented on June 6, 2004 at the upcoming American Society of Clinical Oncology (ASCO) meeting in New Orleans, LA.
"We are extremely pleased and enthusiastic about the clear survival advantage demonstrated in this trial," said David Schenkein, vice president, clinical oncology development, Millennium. "This is the first randomized study of a treatment in the relapsed multiple myeloma setting to show a survival advantage over a current standard of care. Further, these data potentially represent a significant opportunity to make an important difference in extending survival for patients living with multiple myeloma."
The confirmatory phase III APEX trial included patients with relapsed or refractory multiple myeloma whose disease had progressed after receiving one to three previous therapies. The study was halted one year early in December of 2003 after a data monitoring committee concluded the findings of a pre- specified interim analysis showed a statistically significant improvement in time to disease progression -- the primary endpoint of the trial -- in patients receiving Velcade compared to patients receiving high-dose dexamethasone.
Patients were randomized to receive either Velcade or high- dose dexamethasone, a recognized standard of care in this setting. The trial enrolled more than 670 patients in 95 sites in the United States, Canada and Europe. The trial design included a primary endpoint of time to disease progression and secondary endpoints that included measurements of clinical benefit, safety and survival.