ASH: Velcade outperforms Dex

Millennium Pharmaceuticals, Inc. today announced extended survival data from the multi-center phase III APEX trial, the largest randomized study in relapsed myeloma, and the only trial to demonstrate a survival advantage for a single agent, VELCADE, in this setting. The results demonstrate a six-month survival advantage for patients in the VELCADE arm.

VELCADE demonstrated a median overall survival of 30 months.

The updated results, based on median follow-up of 22 months, from the APEX study continue to show VELCADE is superior to high-dose dexamethasone in overall survival and one-year survival rates, response rates and time to progression. The APEX trial was conducted at 93 centers in North America, Europe and Israel and enrolled 669 patients with multiple myeloma who had received one to three prior therapies.

Data from 669 evaluable patients showed:

• Median overall survival was 30 months in the VELCADE arm versus 24 months in the dexamethasone arm providing a six-month survival advantage in the VELCADE arm
• One-year survival was 80 percent in the VELCADE arm versus 67 percent in the dexamethasone arm
• Importantly, statistical significance was maintained even though 62 percent of patients crossed over to receive VELCADE after experiencing progressive disease on the dexamethasone arm

Data from 333 evaluable patients in the VELCADE arm showed:

• Overall response rate was 43 percent
  - 16 percent had complete (nine percent) or near-complete (seven percent) response
  - 34 percent had partial response
• Responding patients received a median number of 10 cycles of treatment
• In patients with 100 percent reduction of M-protein (measurement of disease), duration of response was longer (11.5 months)
• Although median time to response remained rapid at 1.4 months, maximum reduction of M-protein occurred in later cycles of therapy, approximately:
  - 20 percent of patients achieved best M-protein response after cycle 8
  - 30 percent of patients achieved best M-protein response after cycle 6
  - 50 percent of patients achieved best M-protein response after cycle 4
  
  Source: http://www.mlnm.com