Millennium: The Takeda Oncology Company reported results from three studies in relapsed multiple myeloma (MM). Two of the studies examined the use of VELCADE (bortezomib) for injection; the third study presents clinical data on MLN9708, the first investigational oral proteasome inhibitor.
“In these studies, VELCADE-based therapy provided median overall survival results ranging from 20 to 29 months, underscoring the importance of VELCADE in treating patients with relapsed multiple myeloma, including those who had previously been treated with it,” said Nancy Simonian, PhD, and chief medical officer of Millennium.
One analysis examined 42 patients who responded to VELCADE therapy and were retreated with VELCADE either as monotherapy or in combination. The results showed after initial VELCADE therapy, ORR was 100% and the CR/nCR rate was 33%. After retreatment with VELCADE, ORR was 64% and the CR/nCR rate was 29%.
A second study reported interim results from an international electronic observational study that evaluated 432 relapsed/refractory multiple myeloma patients. The results showed that ORR was 72.7 percent in the VELCADE-dexamethasone arm, compared to 68.4 percent in the VELCADE arm. In addition, CR rate was 24.1 percent in the VELCADE-dexamethasone arm, compared to 8.2 percent in the VELCADE arm.
In a Phase 1 dose-escalation study of the investigational agent MLN9708,an oral proteasome inhibitor, data were collected from 35 relapsed/refractory multiple myeloma patients, all of whom had received at least two prior therapies, which must have included VELCADE, lenalidomide or thalidomide, and corticosteroids. Interim data showed that the maximum tolerated dose was established as 2.0 mg/m2 and dose-limiting toxicities (DLT) of grade 3 rash and grade 4 thrombocytopenia were seen at 2.23 mg/m2.
Release Date: May 5, 2011
Source: Millennium: The Takeda Oncology Company
