Doxil/Velcade Prolongs TTP in Myeloma

• ORLANDO—The combination of liposomal doxorubicin (Doxil) and bortezomib (Velcade) significantly improved time to progression (TTP) in patients with relapsed or refractory multiple myeloma, compared with bortezomib alone, according to a planned interim analysis of the phase III open-label, multicenter trial(DOXIL-MMY-3001). Robert Z. Orlowski, MD, PhD, of the University of North Carolina at Chapel Hill, presented the results at the 48th Annual Meeting of the American Society of Hematology (abstract 404).

The 646 patients had failed at least one prior therapy; they were randomized to bortezomib alone at 1.3 mg/m² on days 1, 4, 8, and 11 of a 21-day cycle or bortezomib at the same dose plus liposomal doxorubicin 30 mg/m² on day 4.

For the combination, median TTP was 9.3 months vs 6.5 months for monotherapy (HR 1.82, P = .000004)). The overall response rate (48% vs 43%)

trended in favor of the combination. Response duration was significantly better with the combination (10.2 months vs 7.0 months, P = .0006). There was a trend toward improved overall survival with the combination (HR 1.48, P = .113). The incidence of serious adverse events was higher in the combination arm (36% vs 31%) but was judged to be acceptable. Ortho Biotech has filed a supplemental NDA for Doxil/Velcade for the treatment of myeloma.