Nexavar (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals.(III) of the National Cancer Institute’s Surveillance, Epidemiology and End Results, 2007 Facts and figures
(I) Kumar S, Crowley J, Lee JH, Lahuerta JJ, Morgan G et al. Outcome of patients with relapsed myeloma after bortezomib therapy IMID:. A multicenter international working group poster presentation of the Myeloma Foundation: 15th Congress of the European Hematology Association, June 10-13, 2010, Barcelona, Spain.
As mentioned above 46 ° to the American Society of Clinical Oncology (ASCO), a fellow of the Phase 2 study, known as study 004 has demonstrated encouraging overall response rate, tolerability and sustainable disease control when carfilzomib was administered as single agent in patients with relapsed and / or refractory multiple myeloma. In 53 evaluable patients who had not been previously treated with bortezomib, carfilzomib achieved an overall response rate of 55 % and a median response duration of 11.5 months at 27mg/m2. Forty % of patients were refractory to the latest before entering the trial. 004 in the study population, treatment with carfilzomib was well tolerated and no adverse events or unexpected happened again. The use of any kind was rare, and no grade 4 adverse events were observed.
(Iv) International Agency for Research on Cancer, Globocan 2002 database
The company has also launched a large randomized international Phase 3 clinical trials, known as the ASPIRE trial, the study of the combination of lenalidomide and dexamethasone in low doses, with or without carfilzomib in patients with relapsed multiple myeloma. The Company has entered into an agreement with FDA on Special Protocol Assessment (SPA) and received scientific advice from the European Medicines Agency (EMA) for the design and analysis for the process ASPIRE. A second phase 3 clinical trial, known as the FOCUS trial, is planned to evaluate carfilzomib in patients with and provide a basis for a European registration. Carfilzomib is also being studied in advanced solid tumors.
The 003-A1 study was an open, an arm of the Phase 2b study. The study evaluated 266 patients with heavily pretreated relapsed and refractory multiple myeloma whose disease was refractory to their last treatment and had received at least two prior therapies, including bortezomib, thalidomide or lenalidomide is an alkylating agent, glucocorticoids and an anthracycline . Refractory disease was defined as a response <25percent or progression during treatment or within 60 days after the end of treatment. (Ii) patients in the 003-A1 trial had received a median of five prior therapies, which corresponds to a median of 13 anti-myeloma agents. Patients who completed the 12 cycles were eligible to enter an extension study. Responses and progression were determined according to the International Myeloma Working Group (IMWG) criteria. The study was conducted in collaboration with the Consortium for Research on multiple myeloma (MMRC) and other sites in the United States and Canada.
Multiple myeloma cells is the result of the most common hematologic abnormalities and plasma, usually in the bone marrow. In the United States, more than 50,000 people suffering from multiple myeloma and approximately 20,000 new cases are diagnosed each year. (Iii) in the world, over 180,000 people with multiple myeloma and approximately 86,000 new cases are diagnosed each year. (Iv)
(Ii), Anderson et al. Clinically relevant end points and new drug approvals for myeloma. Leukemia. 22:231
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced positive preliminary results from the Phase 2b 003-A1 carfilzomib monotherapy study, a selective inhibitor of the next generation of the proteasome, in patients with relapsed and refractory. In an independent review of the data, carfilzomib have reached an overall response rate (partial response or greater) of 24 % and a median duration of response of 7.4 months in patients who entered the study after receiving a median five lines before therapy (corresponding to an average of 13 anti-myeloma agents) and whose disease was refractory to their previous system. The clinical benefit rate (minimal response or better) in the study population was 36 %. Carfilzomib was well tolerated and there were no new or unexpected toxicities observed. The full results of the study will be presented in an upcoming scientific meeting
These statements include, without limitation, statements regarding the progress, timing and results of clinical development, safety, regulatory processes, commercialization efforts or potential of carfilzomib. These statements are subject to risks and uncertainties that could cause actual results or events to differ materially from those anticipated, including the risk that operations are not successfully integrated into Proteolix Onyx, Onyx is a risk that can not achieve the anticipated benefits of the acquisition and the risks associated with the development and commercialization of pharmaceutical products. All statements in this press release that are not statements of historical facts may be forward-looking statements. Please refer to the Annual Report on Form 10-K Onyx for the year ended December 31, 2009, filed with the Securities and Exchange Commission under the heading Risk Factors and Onyx’s Quarterly Reports on Form 10-Q for a more detailed discussion of these factors. Readers are cautioned not to place undue reliance on these forward-looking statements are only valid on the date of this release. Onyx undertakes no obligation to publicly update forward-looking statements to reflect new information, events or circumstances after the date hereof, except as provided by law.
Carfilzomib is a selective, next-generation proteasome inhibitor that has shown encouraging results in an extensive program of clinical trials in multiple myeloma.
Despite recent advances in the treatment of multiple myeloma, all patients eventually relapse. Kauffman, MD, Ph.D., Chief Medical Officer of Onyx Pharmaceuticals. A study by the International Working Group of myeloma patients, such as those included in the study 003-A1, can expect to encounter therapy, only 11 % of the time and survive only six to 10 months. (I) ’s single-agent activity with durable disease control and favorable tolerability observed in this study indicate that carfilzomib has the potential to alter the natural course of this deadly disease.