EXTEND SURVIVAL: THE MOST ACTIVE SINGLE-AGENT IN A LARGE RANDOMIZED TRIAL
30-month median overall survival versus 24 months with high-dose dexamethasone in updated APEX analysis (P = 0.0272, median 22-month follow-up, 44% events occurred)*1,2
VELCADE® Is the First and Only Single Agent to Provide a Survival Benefit in Relapsed Multiple Myeloma
Initial APEX analysis: VELCADE demonstrated a significant survival
advantage versus high-dose dexamethasone (survival hazard ratio = 0.57; range: 0.40, 0.81; P less than 0.05 [precise P-value cannot be rendered], median 8.3 months follow-up, 20% events occurred)
* APEX (N = 669) was a prospective, phase 3, international, randomized, stratified, open-label clinical trial in multiple myeloma patients with 1-3 prior therapies (median of 2) which compared single-agent VELCADE to high-dose dexamethasone. Primary endpoint was time to progression (TTP). Exclusion criteria were: refractory to high-dose dexamethasone, platelet count less than 50,000/μL or patients with ≥ grade 2 peripheral neuropathy. Of 333 patients on the VELCADE arm, 315 were evaluable for response.
Of 336 patients on the dexamethasone arm, 312 were evaluable for response. Patients were randomized to receive either VELCADE 1.3 mg/m2 bolus IV injection for 8 cycles or dexamethasone 40 mg for 4 cycles. The trial was terminated at a preplanned interim analysis of TTP. All dexamethasone patients were offered VELCADE. With continued follow-up (median 22 months), median overall survival was reached in both arms: 30 months with VELCADE versus 24 months with dexamethasone (survival hazard ratio = 0.77; range: 0.61, 0.97; P = 0.0272); Kaplan-Meier plot was redrawn.
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