2012 Press Releases
Onyx Pharmaceuticals Initiates Phase 3 Kyprolis™ Head-to-Head Comparison Trial vs. Velcade® in Patients with Relapsed Multiple Myeloma
South San Francisco, CA. Jul. 02, 2012
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that the company has begun enrollment in the ENDEAVOR trial, a Phase 3 trial evaluating KyprolisTM (proposed brand name for carfilzomib) in combination with dexamethasone, versus bortezomib (Velcade®) with dexamethasone in patients with relapsed multiple myeloma.
“The ENDEAVOR trial is the first head-to-head trial conducted with Kyprolis, and is an important step in the development program,” said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. “The initiation of this trial underscores our commitment to patients with multiple myeloma who are in need of new treatment options beyond the currently available therapies.”
The FDA is currently reviewing a New Drug Application (NDA) for potential accelerated approval of Kyprolis in the United States for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD). The Prescription Drug User Fee Act (PDUFA) date for completion of the NDA review by the FDA is July 27, 2012.
Phase 3 Trial Design
The ENDEAVOR (RandomizEd, OpeNLabel, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial is an 888 patient study evaluating Kyprolis in combination with dexamethasone, versus Velcade® (bortezomib) with dexamethasone in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens. The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival, overall response rate, duration of response, and safety. Patients will be randomized to receive Kyprolis intravenously (20mg/m2 on days 1 and 2 of cycle 1 only, then 56 mg/m2 subsequently) with low-dose dexamethasone (20mg), versus bortezomib (1.3 mg/m2) with low-dose dexamethasone. Bortezomib can be administered subcutaneously or intravenously at the discretion of the investigator and in accordance with regulatory approval of bortezomib. The study will be conducted at approximately 200 sites worldwide. For information about this study, please visit www.clinicaltrials.gov under trial identification number NCT01568866.
About the Kyprolis™ (proposed brand name for carfilzomib) Development Program
Kyprolis is an investigational agent and is not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other health authorities.
The NDA submission currently under review by the FDA is based on the Kyprolis 003-A1 study, an open-label, single-arm Phase 2b trial of Kyprolis (20mg/m2 in cycle 1 and 27mg/m2 in subsequent cycles), as well as supportive data from additional studies.
In addition to the ENDEAVOR trial, Kyprolis is being studied in several clinical trials either as a single-agent or in combination with other therapies, including:
- A Phase 3 clinical trial, known as the ASPIRE trial, has completed enrollment and is evaluating the combination of lenalidomide and low-dose dexamethasone with or without Kyprolis in patients with relapsed multiple myeloma who have received one to three prior therapies. The company has an agreement with the FDA on a Special Protocol Assessment (SPA) and has received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the trial.
- A Phase 3 clinical trial, called the FOCUS trial, is evaluating single-agent Kyprolis in patients with relapsed and refractory myeloma who have received three or more prior therapies. The trial is designed to facilitate regulatory approvals around the world.
- A Phase 1/2 study, being conducted by Onyx’s partner Ono Pharmaceutical Co., Ltd, is evaluating Kyprolis in Japanese patients with relapsed/refractory multiple myeloma.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually.i Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually.ii
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.
This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the progress and results of the clinical development, the expanded access program, safety, regulatory processes, commercialization efforts or commercial potential of Kyprolis (carfilzomib). These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks related to the submission, review, potential approval of the NDA, development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2011, 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 description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
i National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
ii International Agency for Research on Cancer, GLOBOCAN 2002 database