MMRF PRESS RELEASES
Multiple Myeloma Research Consortium (MMRC) Helps to Advance Clinical Development of Carfilzomib
Top-line Phase IIb Data from Onyx Pharmaceuticals Trial May Form the Basis for NDA Filing in Advanced Myeloma
Norwalk, CT — July 28, 2010
Positive data from the pivotal Phase IIb clinical trial (003-A1) of Onyx Pharmaceutical’s carfilzomib in relapsed and refractory multiple myeloma, one of 25 clinical trials conducted entirely or in part through the Multiple Myeloma Research Consortium (MMRC), may provide the foundation for Onyx to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by year-end, for potential accelerated approval. The 003-A1 trial was conducted through the Multiple Myeloma Research Consortium (MMRC) as part of its commitment to accelerating the development of next-generation treatments for multiple myeloma, an incurable blood cancer.
“The MMRC provides strategic solutions that have injected speed and efficiency at many points during the carfilzomib clinical trials,” said Michael G. Kauffman, M.D., Ph.D., Chief Medical Officer of Onyx Pharmaceuticals. “We are grateful for the MMRC’s continued commitment to accelerating the availability of carfilzomib, and consider them a true partner in the development of this potential new treatment option.”
In 2006, the MMRC identified carfilzomib as a promising new treatment during its development by Proteolix, Inc. (now a part of Onyx), and entered into a collaboration to support the therapy’s development for relapsed/refractory multiple myeloma. MMRC development support included:
- Providing access to and strategic counsel around engaging its network of experts and securing 003-A1 investigators;
- Supplying the company with access to centralized contracts and guidance on site selection and protocol design to accelerate initiation of the 003-A1 trial; and,
- Accrual of 60 percent of patients into the trial via MMRC Member Institutions, which represented 36 percent of the total number of study sites. These efforts were important in rapidly completing the trial’s enrollment and rendering high-quality data.
“With so few treatment options for multiple myeloma patients with advanced disease, there is a significant and unmet need for the development of new treatments, such as carfilzomib and other new treatments under study in the MMRC,” said Kathy Giusti, Founder and Chief Executive Officer of the MMRC and a multiple myeloma patient. “We are extremely proud to have worked side-by-side with the team developing carfilzomib and to have played a role in generating these results, particularly since they may form the basis for an NDA submission by year-end.”
Findings from the Onyx-sponsored 003-A1 trial showed that 36 percent of patients responded to carfilzomib, with 24 percent of patients reaching a partial response or better for a median duration of 7.4 months. Patients in 003-A1 had received a median of five prior therapeutic regimens – representing 13 different anti-myeloma drugs – and were refractory to their last treatment.
Through its clinical trials network, the MMRC also collaborated on the Phase II trial (004) of carfilzomib in multiple myeloma patients who had relapsed after one to three prior therapies and a Phase I/II clinical trial of carfilzomib in combination with lenalidomide (Revlimid®) and dexamethasone (CRD) in patients with newly diagnosed, previously untreated multiple myeloma. Carfilzomib is one of 14 promising compounds under study in clinical trials being conducted through the MMRC; four of these compounds have moved into Phase III clinical trials.
About the Multiple Myeloma Research Consortium (MMRC)
The Multiple Myeloma Research Consortium (MMRC) is a 509(a)3 non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. It is led from MMRC offices in Norwalk, Conn., and comprises 13 member institutions: University of California, San Francisco, City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, the Cancer Center at Hackensack University Medical Center, H. Lee Moffitt Cancer Center & Research Institute, Mayo Clinic, Ohio State University, Mount Sinai School of Medicine, University Health Network (Princess Margaret Hospital), University of Chicago, University of Michigan, and Washington University. The MMRC was founded in 2004 by Kathy Giusti, a myeloma patient, and with the help of the scientific community. The MMRC is a sister organization to the Multiple Myeloma Research Foundation (MMRF), the world's leading funder of multiple myeloma research. The MMRC is widely recognized as an optimal research model to rapidly address critical challenges in drug development and to explore opportunities in today's most promising research areas–genomics, compound validation, and clinical trials. The MMRC is the only consortium to join academic institutions through membership agreements, customized IT systems, and an integrated tissue bank. For more information, please visit: www.themmrc.org.