Multiple Myeloma Patients Respond to Retreatment with VELCADE(R) (Bortezomib) for Injection
Monday December 11, 10:30 am ET
[Intriguing that some patients, who did not respond the first time, did the second. Unless it was the other drug in a combination that produced the response. Let's hope, that with all this competetive testing with Velcade/Thalidomid/Revlimid that goes on, a better understanding and better treatment options are gained for MM]
- Data show patients who received a first course of VELCADE therapy benefit from subsequent VELCADE based treatment -
ORLANDO, Fla., Dec. 11 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced findings from two retrospective analyses evaluating VELCADE®(bortezomib) for Injection as retreatment therapy in heavily pretreated relapsed multiple myeloma (MM) patients. These data showed overall response rates (complete response [CR] and partial response [PR]) to retreatment as high as 60 percent among patients who had an initial response to VELCADE treatment and as high as 29 percent among patients who did not show a response to their initial VELCADE treatment. These data were presented at the American Society of Hematology (ASH) 48th Annual Meeting in Orlando, Fla., December 9-12, 2006 and show repeat use of VELCADE in relapsed MM patients can improve disease outcomes, including in patients who did not respond to their first treatment of VELCADE.
"Relapsed patients have limited treatment options as they often develop resistance to therapy, especially when treated to progression," said Dixie Esseltine, M.D., Vice President, Global Medical Affairs, Millennium. "These results showed that patients can receive VELCADE in multiple lines of therapy, with treatment-free intervals and potentially benefit from retreatment with VELCADE with an improved clinical response."
Utility of VELCADE (Bortezomib) Retreatment for Patients with Relapsed Multiple Myeloma (Abstract #3532)
The retrospective review of 22 patients primarily from the Phase II SUMMIT and CREST and Phase III APEX studies was designed to assess the efficacy and safety of VELCADE based therapy as retreatment. Patients had received a median of 3.5 therapies prior to their initial VELCADE based treatment. VELCADE was dosed at 1.3 mg/m2 on days 1, 4, 8 and 11 for a median of 7.5 three-week cycles. In response to initial VELCADE therapy, ORR was 68 percent. As retreatment, patients received VELCADE as a single agent or in combination for a median of 5.5 cycles following at least a 60-day treatment break. Patient response was determined using M-protein values. The study was presented by Jeffrey Wolf, M.D., Alta Bates Comprehensive Cancer Center, Berkeley, Calif., and showed:
* Of all patients in the analysis, ORR to retreatment was 50 percent
-- Of patients who initially responded to VELCADE, ORR to retreatment
was 60 percent
-- Of patients who did not initially respond to VELCADE, ORR to
retreatment was 29 percent
* Of responding patients who had a treatment-free interval of at least
six months after their first treatment with VELCADE, the ORR was higher
at 75 percent
* During retreatment two patients withdrew due to toxicities
compared to three patients during initial treatment; no patients
required dose reduction for peripheral neuropathy compared to four
patients during initial treatment
An Observational, Retrospective Analysis of Retreatment with VELCADE (Bortezomib) of Multiple Myeloma Patients (Abstract #3531)
The retrospective analysis examined the efficacy and safety of VELCADE as retreatment in 95 MM patients who received at least two VELCADE based therapies. These patients were identified in the U.S. Oncology claims database. In response to initial therapy, 57 percent of patients achieved a PR or better. VELCADE was given as a single agent or in combination, and patients received a median of four and two VELCADE cycles during the first and second treatment, respectively. Median time between first and second VELCADE treatment was five months. The study was presented by Therese Conner, Outcomes Research, U.S. Oncology, Houston, Texas. Results showed:
* Of all patients in the analysis, ORR was 20 percent upon retreatment
regardless of initial response
* Of patients who achieved a PR or better on initial therapy, 32 percent
achieved at least a PR upon retreatment
* The most common adverse event was neuropathy; number of patients who
stopped treatment due to toxicity was lower with retreatment compared to
initial treatment
Data from the multicenter Phase IV EVEREST trial evaluating retreatment with VELCADE were presented at this year's European Society for Medical Oncology Conference. The ORR from this study was 39 percent. |
