Millennium Discovers Biomarkers Potentially Predictive of Response to VELCADE® for Injection
News Apr 23, 2007
Findings published in the April 15th issue of Blood show that a team of researchers led by Millennium Pharmaceuticals, Inc. has discovered biomarkers which may lead to identifying multiple myeloma patients likely to respond to VELCADE.
Findings published in Blood highlight Millennium leadership in personalized medicine and could strengthen the role of VELCADE as foundation of therapy in broad range of multiple myeloma patients.
VELCADE is a therapy for previously treated multiple myeloma patients with an unsurpassed median survival of 29.8 months as a single agent.
These findings add to the body of evidence that supports the role of VELCADE in the treatment of a broad range of multiple myeloma patients and highlight the applicability of genomics research. This research, in combination with similar ongoing studies, may ultimately lead to improved outcomes for patients.
The identification of these biomarkers was the result of a collaborative effort by researchers from Millennium and leading multiple myeloma academic centers. These centers included Dana-Farber Cancer Institute, Boston; Myeloma Institute of Research and Therapy at the University of Arkansas for Medical Services, Little Rock; Mayo Clinic, Scottsdale; and Department of Hematology, Erasmus Medical Center, Rotterdam.
The combined team performed genomics analyses on tumor samples from multiple myeloma patients in VELCADE clinical trials. These trials included the APEX Phase III study, which demonstrated the superiority of VELCADE over standard-of-care dexamethasone in previously treated multiple myeloma patients and is one of the first and largest prospective randomized trials to include genomics analyses.
Findings from the analyses showed that patients with an increased expression of genes in the NFk-B and adhesion molecule pathways may be more sensitive to VELCADE therapy.
Additionally, these findings showed that the biomarkers did not predict sensitivity to dexamethasone therapy, indicating that the biomarkers may be specific to VELCADE.
"Millennium is recognized as a leader in personalized medicine, and this publication is a testament to the strength of our clinical innovation," said Nancy Simonian, M.D., Chief Medical Officer, Millennium.
"The genomic findings add further knowledge about VELCADE efficacy in treating a broad range of multiple myeloma patients."
Millennium and its co-development partner, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) is continuing genomics research on VELCADE in additional trials. Studies include a Phase III trial conducted by the Dutch and German co-operative groups, HOVON and GMMG, which is evaluating a VELCADE based combination in patients with newly diagnosed multiple myeloma.
In addition, genomics research is ongoing in a Phase III trial evaluating a VELCADE based combination therapy in indolent non-Hodgkin's lymphoma.
"While the published results represent an important step forward in our genomics research, the next critical step is to conduct similar analyses with VELCADE in combination with other anti-cancer agents," said George Mulligan PhD, Associate Director, Translational Medicine, Millennium.
"We are committed to improving outcomes for multiple myeloma patients and this work should bring us closer to determining optimal treatment strategies," Mulligan added.
China is poised to introduce a new regulation on gene editing in humans. A draft of the country’s new civil code lists human genes and embryos in a section on personality rights to be protected. Experiments on genes in adults or embryos that endanger human health or violate ethical norms can accordingly be seen as a violation of a person’s fundamental rights.READ MORE