Onyx Pharmaceuticals Announces Data Presentations Highlighting Carfilzomib and Oprozomib at 54th American Society of Hematology Annual Meeting
Data From Proteasome Inhibitor Franchise to Be Presented
(firmenpresse) - SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 11/06/12 -- Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced the presentation of several studies evaluating carfilzomib, a selective, irreversible proteasome inhibitor, and oprozomib, an investigational oral proteasome inhibitor, previously known as ONX0912, at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition on December 8-11, 2012 at the Georgia World Congress Center in Atlanta, GA.
"The results being presented at ASH add to the depth and breadth of clinical experience for carfilzomib in a range of multiple myeloma disease settings, and begin to build our clinical understanding of oprozomib," said Barbara Klencke, M.D., Senior Vice President of Clinical Development at Onyx Pharmaceuticals. "We are encouraged by the data to be presented and the ongoing investigator and company-sponsored studies that will expand our knowledge of the appropriate use of carfilzomib. We remain committed to further studying our proteasome inhibitor therapies in multiple myeloma, other hematologic malignancies and, potentially, solid tumors."
Phase II Study of Infusional Carfilzomib in Patients with Relapsed or Refractory Multiple Myeloma
Dr. Nikoletta Lendvai, Memorial Sloan-Kettering Cancer Center
Tuesday, December 11, 8:30 - 8:45 a.m., Thomas Murphy Ballroom 2-3
Oral Session: Myeloma - Therapy, excluding Transplantation: Clinical issues in myeloma and amyloidosis patients: novel agent and novel agent-based combinations
Abstract # 947
Results from the Phase II Dose Expansion of Cyclophosphamide, Carfilzomib, Thalidomide and Dexamethasone (CYCLONE) in Patients with Newly Diagnosed Multiple Myeloma
Dr. Joseph Mikhael, Mayo Clinic
Monday, December 10, 10:30 - 10:45 a.m., Thomas Murphy Ballroom 2-3
Oral Session: Myeloma - Therapy, excluding Transplantation II
Abstract # 445
Carfilzomib Combined with Thalidomide and Dexamethasone (CTD) Is an Highly Effective Induction and Consolidation Treatment in Newly Diagnosed Patients with Multiple Myeloma (MM) Who Are Transplant Candidate
Dr. Pieter Sonneveld, Erasmus Medical Center, Rotterdam, Netherlands
Monday, December 10, 7:30 - 7:45 a.m., Thomas Murphy Ballroom 2-3
Oral Session: Myeloma - Therapy, excluding Transplantation: Treatment options for newly diagnosed myeloma patients
Abstract # 333
Carfilzomib, Cyclophosphamide and Dexamethasone (CCd) for Newly Diagnosed Multiple Myeloma (MM) Patients
Dr. Antonio Palumbo, University of Torino, Italy
Monday, December 10, 5:15 - 5:30 p.m., Thomas Murphy Ballroom 2-3
Oral Session: Myeloma - Therapy, excluding Transplantation III
Abstract # 730
Phase II Clinical and Correlative Study of Carfilzomib, Lenalidomide, and Dexamethasone (CRd) in Newly Diagnosed Multiple Myeloma (MM) Patients
Dr. Ola Landgren, National Cancer Institute (NCI)
Monday, December 10, 5:45 - 6:00 p.m., Thomas Murphy Ballroom 2-3
Oral Session: Myeloma - Therapy, excluding Transplantation III
Abstract # 732
A Multi-Center Phase I/II Trial of Carfilzomib and Pomalidomide with Dexamethasone (Car-Pom-d) in Patients with Relapsed/Refractory Multiple Myeloma
Dr. Jatin Shah, The University of Texas MD Anderson Cancer Center
Sunday, December 9, 12:15 - 12:30 p.m., Thomas Murphy Ballroom 2-3
Oral Session: Myeloma - Therapy, excluding Transplantation: Phase I-II trials in Relapsed and Relapsed-Refractory myeloma patients
Abstract # 74
Cardiac Event Rates in Patients with Newly Diagnosed and Relapsed Multiple Myeloma in US Clinical Practice
Dr. Kristin Kistler, United BioSource Corporation
Sunday, December 9, 6:00 - 8:00 p.m., Hall B1-B2
Poster Session: Myeloma - Biology and Pathophysiology, excluding Therapy: Poster II
Abstract #2916
A Phase Ib Study of 30-minute Infusion Carfilzomib 20/45 and 20/56 mg/m2 plus 40 mg Weekly Dexamethasone in Patients with Relapsed and/or Refractory (R/R) Multiple Myeloma
Dr. Ashraf Badros, University of Maryland Medical Center
Monday, December 10, 6:00 - 8:00 p.m., Hall B1-B2
Poster Session: Myeloma - Therapy, excluding Transplantation: Poster III
Abstract # 4036
Cardiac and Pulmonary Safety Profile of Single-agent Carfilzomib from Four Phase II Studies in Patients with Relapsed and/or Refractory Multiple Myeloma
Dr. Sagar Lonial, Winship Cancer Institute of Emory University
Monday, December 10, 6:00 - 8:00 p.m., Hall B1-B2
Poster Session: Myeloma: Therapy, excluding Transplantation: Poster III
Abstract # 4037
A Phase II Study of Prolonged Carfilzomib Therapy in Patients with Multiple Myeloma Previously Enrolled in Carfilzomib Phase 1 and 2 Clinical Trials
Dr. David Siegel, Hackensack University Medical Center
Sunday, December 9, 6:00 - 8:00 p.m., Hall B1-B2
Poster Session: Myeloma: Therapy, excluding Transplantation: Poster II
Abstract # 2962
A Phase Ib Dose-escalation Study of Split-dose Oprozomib (ONX0912) in Patients with Hematologic Malignancies
Dr. Michael Savona, Tennessee Oncology
Sunday, December 9, 5:30 - 5:45 p.m., Thomas Murphy Ballroom 2-3
Oral Session: Myeloma - Therapy, excluding Transplantation I
Abstract # 203
On July 20, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Kyprolis™ (carfilzomib) for Injection for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent Kyprolis. There were 37 deaths in the phase 2 studies, or 7% of patients. The most common causes of death, other than disease progression, were cardiac (5 patients), end-organ failure (4 patients), and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia; pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with Kyprolis and was Grade 3 or greater in less than 1% of patients. Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina can occur immediately following or up to 24 hours after administration of Kyprolis. Administration of dexamethasone prior to Kyprolis reduces the incidence and severity of reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis administration in < 1% of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with Kyprolis in < 1% of patients.
Cases of hepatic failure, including fatal cases, have been reported (< 1%). Kyprolis can cause elevations of serum transaminases and bilirubin.
There are no adequate and well-controlled studies in pregnant women using Kyprolis. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis.
The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia, and congestive heart failure. The most common adverse reactions (incidence of 30% or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Serious adverse reactions were reported in 45% of patients.
Full prescribing information is available at .
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.(1) Worldwide, more than 220,000 people are living with multiple myeloma and approximately 100,000 new cases are diagnosed annually.(2)
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 .
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, safety, regulatory processes, commercialization efforts or commercial potential of Kyprolis (carfilzomib) or oprozomib. 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 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.
(1) American Cancer Society, Cancer Facts & Figures 2012
(2) National Analysts & Kantar Health Market Research
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 06.11.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 1167548
Anzahl Zeichen: 0
contact information:
Contact person:
Town:
SOUTH SAN FRANCISCO, CA
Phone:
Kategorie:
Surgery & Treatments
Anmerkungen:
Diese Pressemitteilung wurde bisher 181 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Onyx Pharmaceuticals Announces Data Presentations Highlighting Carfilzomib and Oprozomib at 54th American Society of Hematology Annual Meeting
"
steht unter der journalistisch-redaktionellen Verantwortung von
Onyx Pharmaceuticals, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
