The findings were from an ongoing phase II National Cancer Institute-sponsored study and final results from a phase II investigator initiated study examining the potential role of Velcade (bortezomib) in patients with various forms of non-Hodgkin’s lymphoma (NHL).
In the National Cancer Institute-sponsored study, patients with follicular, mantle cell, small lymphocytic and marginal zone lymphoma received single-agent Velcade at 1.5mg/m2 twice weekly for two weeks every 21 days. Results included a 58% overall response rate in 24 evaluable patients of the 26 enrolled and generally manageable adverse events.
A separate, second study studied patients 16 years of age or older, with relapsed or refractory B-cell NHL. Patients were stratified into two arms, one mantle cell lymphoma and one B-cell lymphomas. Patients received single agent Velcade at 1.5mg/m2 twice weekly for two weeks every 21 days for up to six cycles. Results included a 41% patient response rate in the mantle cell lymphoma group and a 19% response rate in the B-cell lymphoma group.
“These studies provide evidence of promising activity of bortezomib in patients with both indolent and aggressive types of NHL that failed multiple prior therapies, and the studies are now being expanded to multiple centers to accumulate further experience of the efficacy of bortezomib against these lymphomas,” said Dr O’Connor, head of the laboratory of experimental therapeutics for the lymphoproliferative malignancies at Memorial Sloan-Kettering Cancer Center.
“We are very encouraged by the potential Velcade demonstrated in these patients with aggressive and indolent lymphoma,” stated Dr David Schenkein, vice president of clinical oncology development at Millennium. “These results support our goal of broadly exploring the use of Velcade in a number of hematological cancers, and we look forward to presenting additional lymphoma data during the first half of this year.”
Velcade is being co-developed by Millennium and Johnson & Johnson Pharmaceutical R&D. Millennium is responsible for commercialization of Velcade in the US, Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world, and Janssen Pharmaceutical KK is responsible for Japan.