EARLIER TREATMENT, IMPROVED SURVIVAL IN APEX
Survival by Number of Prior Therapies*
In APEX, patients with 1 prior therapy had a median survival of greater than 31 months (median not reached with 22 months of follow-up). Patients with 2 to 3 prior therapies had a 23-month median overall survival.
*Survival by number of prior therapies was based on a retrospective subset analysis of the APEX trial.
EARLIER TREATMENT, INCREASED RESPONSE
Overall Response (CR + PR)†2 to VELCADE® in APEX
In APEX
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Patients with 1-3 prior therapies treated with single-agent VELCADE achieved 9% complete response (CR); 34% achieved partial response (PR), of which 7% achieved near complete response (nCR)
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Response rates were independent of: beta2 -microglobulin level, chromosome 13 deletion status, or age ≥ 65
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Patients receiving single-agent VELCADE had a median time to progression (TTP) of 6.2 months
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†In APEX, 251 patients (38%) received 1 prior therapy; 128 were evaluable on the VELCADE arm (n=132) and 110 were evaluable on the dexamethasone arm (n=119). Initial analysis at study termination: overall response rate (CR + PR) for patients with a median of 2 prior therapies was 38%, and 45% for those with 1 prior therapy. With updated follow-up (median 22-month follow-up), the response rates for VELCADE were updated. Overall response was based on criteria established by the European Group for Blood and Marrow Transplantation (EBMT) with an additional category for near complete response (nCR). Complete response (CR) required 100% disappearance of the original myeloma protein from blood and urine on at least 2 determinations 6 weeks apart by immunofixation,
less than 5% plasma cells in the bone marrow, stable bone disease, and normal calcium. Near complete response (nCR) required that all CR criteria be met except that immunofixation was positive. Partial response (PR) required
≥ 50% reduction in serum myeloma protein and ≥ 90% reduction in urine myeloma protein on at least 2 determinations 6 weeks apart, stable bone disease and normal calcium.
‡Retrospective subset analysis of patients who received VELCADE on APEX study (n=118) matched with patients from the dexamethasone arm who crossed over to receive VELCADE in a companion
study (n=118). Patients were matched for number of prior therapies, age, prior thalidomide, and
baseline albumin. One hundred two (102) patients were evaluable for response in each group.
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