The findings from the MLN2704 single ascending dose trial indicated that the novel antibody-chemotherapeutic was well tolerated and produced sustained anti-tumor activity, including one patient who achieved a durable partial response in measurable disease for 11 months, as well as a sustained prostate specific antigen (PSA) decline of more than 50%.
The two Velcade (bortezomib) studies in patients with progressive hormone-refractory prostate cancer, were a phase I/II clinical trial of Velcade in combination with docetaxel (Sanofi-Aventis’ Taxotere) and a phase II study of Velcade with and without steroids.
The findings from the study evaluating Velcade for injection and 40mg docetaxel in combination indicated that the combination was well tolerated and showed promising activity. Specifically, in the higher Velcade dose cohort, there were two partial responses in 18 patients with measurable disease and there were confirmed PSA declines of at least 50% in 36% of the 28 evaluable patients.
Findings from the phase II study of Velcade showed that, of nine patients with measurable disease, two patients achieved stable PSA and stable scans at 12 weeks, two patients had a stable PSA at 12 weeks but progressed radiographically, and one patient in the higher dose group demonstrated a partial response on scans but PSA continued to rise.