Biotech Tracker News - Millennium’s (NASDAQ: MLNM) Velcade (bortezomib) is a promising developmental compound
December 04, 2002 Millennium’s (NASDAQ: MLNM) Velcade (bortezomib) is a promising developmental compound currently in phase III clinical trials for the treatment of multiple myeloma. BiotechTracker’s modeling shows that, whereas similar developmental compounds have a 64% probability of FDA approval, Velcade’s probability of approval approaches 75%.  Velcade will be a hot topic at the American Society of Hematology meetings (ASH), which begin on Friday. Velcade will be featured on Monday at a platform presentation, “A Phase II Multicenter Study of the Proteasome Inhibitor Bortezomib (VELCADE, Formerly PS-341) in Multiple Myeloma Patients (pts) with Relapsed/Refractory Disease.” The presentation will demonstrate the clinical utility of Velcade using a data set considering the entire 202-patient phase II cohort. The data augment earlier material from evaluation of Velcade in 78 patients.  The researchers have completed the treatment phase of this clinical trial that assessed Velcade use in study subjects with advanced, relapsed/refractory multiple myeloma. The study participants received a rapid intravenous infusion of Velcade 1.3 mg/m2 on days 1, 4, 8, and 11 of a 21-day cycle for up to 8 cycles. Dexamethasone co-therapy was permitted for those with progressive myeloma after 2 cycles or stable myeloma after 4. Tumor response rate was the surrogate marker used as an appropriate phase II primary endpoint.  202 study subjects were evaluated in 2 sub-cohorts. Sub-cohort 1 assessed the initial 78 patients. This group had received a mean of 5 prior treatment regimens and was a median 4 years from its initial diagnosis of multiple myeloma. 74% of these subjects had previously received thalidomide with 54% having received high-dose therapy. A pre-dexamethasone assessment of Velcade response revealed:  an overall response rate of 32%  a major response rate of 27% (4% complete, 23% partial)  a 9% “near complete” response rate given the absence of but one specific criteria  a 4% complete response rate  68% of patients had either decreased or stable paraprotein, M-protein, levels.  The median duration of response for complete and partial responders had yet to be reached at abstract submission – 10.2 months (median) of follow-up. Evidence of a Velcade contribution to improved hemoglobin, improved performance status, enhanced quality-of-life, and responsive levels of non-M-protein immunoglobulins was observed.  At Monday’s platform presentation, we will further appraise efficacy and safety data that includes an analysis of the contribution of dexamethasone co-therapy as well as more data describing the therapeutic effects seen for both sub-cohorts.  A poster presentation Monday will also address Velcade’s therapeutic effects in patients with earlier stage disease (relapsed or refractory multiple myeloma after front-line therapy). 54 subjects received either rapidly infused Velcade 1.0 mg/m2 or 1.3 mg/m2 on days 1, 4, 8, and 11 of a 21-day cycle for up to 8 cycles. Dexamethasone co-therapy was allowed for those with progressive or stable disease after 2 and 4 cycles, respectively. The primary objective, again, was tumor response rate.  Other significant Velcade presentations at ASH will survey utility in terms of:  preliminary phase I evidence, that merits further research, of significant although transient proteasome inhibition in patients with refractory or relapsed acute leukemias and myelodysplastic syndromes  preliminary phase I evidence, that merits further research, that Velcade plus Doxil (pegylated, liposomal doxorubicin from Alza) is well tolerated and has significant biological activity against multiple myeloma and possibly other refractory hematologic malignancies  preliminary pharmacogenomic responder/non-responder profiles will be available, as will confirmation of reassuring animal pharmacokinetic and tissue distribution profiles.
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