SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 05/21/13 -- Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced the upcoming presentation of data highlighting Kyprolis® (carfilzomib) for Injection, a second-generation proteasome inhibitor, and oprozomib, an oral proteasome inhibitor in early development, at the 18th Congress of the European Hematology Association (EHA) Annual Meeting, June 13-16, 2013 in Stockholm, Sweden.
"The data to be presented at EHA highlight the growing body of clinical experience supporting the potential of carfilzomib across all lines of multiple myeloma, and further enhance our understanding of the new tablet formulation of oprozomib in patients with hematologic malignancies," said Pablo Cagnoni, M.D., Executive Vice President, Global Research & Development and Technical Operations at Onyx Pharmaceuticals. "We are encouraged by the progress of our proteasome inhibitor development program and remain committed to bringing these potential therapies to patients around the world as quickly as possible."
Final results from the Phase 1b/2 study (PX-171-006) of carfilzomib (CFZ) in combination with lenalidomide and low-dose dexamethasone (CRd) for patients with relapsed or progressive multiple myeloma
•Dr. Ruben Niesvizky, Weill Cornell Medical College, United States •Saturday, June 15, 4:30-4:45 pm CEST •Oral Session: Clinical studies in Multiple Myeloma 1, Victoria Hall •Abstract #S577
Carfilzomib, cyclophosphamide and dexamethasone (CCd) for newly diagnosed multiple myeloma (MM) patients: Initial results of a multicenter, open-label Phase 2 study
•Dr. Antonio Palumbo, University of Torino, Italy •Saturday, June 15, 4:45-5:00 pm CEST •Oral Session: Clinical studies in Multiple Myeloma 1, Victoria Hall •Abstract #S578
Phase 1 study of the novel kinesin spindle protein inhibitor ARRY-520 + carfilzomib (CAR) in patients with relapsed and/or refractory multiple myeloma (RRMM)
•Dr. Jatin Shah, MD Anderson Cancer Center, United States •Saturday, June 15, 5:00-5:15 pm CEST •Oral Session: Clinical studies in Multiple Myeloma 1, Victoria Hall •Abstract # S579
CMP -- carfilzomib (CFZ) plus melphalan-prednisone (CMP) -- in elderly patients with newly diagnosed multiple myeloma (NDMM): Results of a Phase 1/2 trial
•Dr. Philippe Moreau, University of Nantes, France •Friday, June 14, 5:45-7:00 pm CEST •Poster Session: Multiple myeloma - Translational and clinical studies 1, Poster Hall •Abstract # P224
Phase 2 clinical and correlative study of carfilzomib, lenalidomide, and dexamethasone followed by lenalidomide extended dosing (CRd-R) in newly diagnosed multiple myeloma (MM) patients
•Dr. Ola Landgren, National Cancer Institute (NCI), United States •Friday, June 14, 5:45-7:00 pm CEST •Poster Session: Multiple myeloma - Translational and clinical studies 1, Poster Hall •Abstract # P228
Phase 1 study of the combination of carfilzomib and panobinostat for patients with relapsed and refractory myeloma: a multicenter MMRC clinical trial
•Dr. Jonathan Kaufman, Winship Cancer Institute, United States •Saturday, June 15, 5:45-7:00 pm CEST •Poster session: Multiple myeloma - Translational and clinical studies 2, Poster Hall •Abstract # P771
Preliminary results of a Phase 1/2 study of carfilzomib, lenalidomide, vorinostat and dexamethasone (QUAD) in relapsed and/or refractory multiple myeloma
•Dr. David Siegel, Hackensack University Medical Center, United States •Saturday, June 15, 5:45-7:00 pm CEST •Poster Session: Multiple myeloma - Translational and clinical studies 2, Poster Hall •Abstract # P774
Clinical profile of once-daily, modified-release oprozomib tablets in patients with hematologic malignancies: Results of a Phase 1b/2 trial
•Dr. Jonathan Kaufman, Winship Cancer Center, United States •Friday, June 14, 5:45-7:00 pm CEST •Poster Session: Multiple myeloma - Translational and clinical studies 1, Poster Hall •Abstract # P233
Important Indication and Safety Information Regarding Kyprolis® (carfilzomib) for Injection
Kyprolis® (carfilzomib) for Injection is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
The safety of KYPROLIS was evaluated in clinical studies of 526 patients with relapsed and/or refractory multiple myeloma.
Death due to cardiac arrest has occurred within a day of KYPROLIS administration. New onset or worsening of pre-existing congestive heart failure with decreased left ventricular function or myocardial ischemia have occurred following administration of KYPROLIS. Cardiac failure events (e.g. congestive heart failure, pulmonary edema, ejection fraction decreased) were reported in 7% of patients. Monitor for cardiac complications and manage promptly. Withhold KYPROLIS for Grade 3 or 4 cardiac events until recovery and consider whether to restart KYPROLIS based on a benefit/risk assessment. 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 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. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for pulmonary hypertension until resolved or returned to baseline and consider whether to restart KYPROLIS based on a benefit/risk assessment.
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. Monitor and manage dyspnea immediately; interrupt KYPROLIS until symptoms have resolved or returned to baseline.
Infusion reactions were 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. These reactions can occur immediately following infusion or up to 24 hours after administration of KYPROLIS. Administer dexamethasone prior to KYPROLIS to reduce the incidence and severity of reactions. Inform patients of the risk and symptoms, and to contact physician if symptoms of an infusion reaction occur.
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. Prior to receiving KYPROLIS, ensure that patients are well hydrated. Monitor for evidence of TLS during treatment, and manage promptly. Interrupt KYPROLIS until TLS is resolved.
KYPROLIS causes thrombocytopenia with platelet nadirs occurring around Day 8 of each 28-day cycle and recovery to baseline by the start of the next 28-day cycle. In patients with multiple myeloma, 36% of patients experienced thrombocytopenia, including Grade 4 in 10%. Thrombocytopenia following KYPROLIS administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with KYPROLIS in < 1% of patients. Monitor platelet counts frequently during treatment with KYPROLIS. Reduce or interrupt dose as clinically indicated.
Cases of hepatic failure, including fatal cases, have been reported ( < 1%). KYPROLIS can cause elevations of serum transaminases and bilirubin. Withhold KYPROLIS in patients experiencing Grade 3 or greater elevations of transaminases, bilirubin, or other liver enzyme abnormalities until resolved or returned to baseline. After resolution, consider if restarting KYPROLIS is appropriate. Monitor liver enzymes frequently.
KYPROLIS can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. There are no adequate and well-controlled studies in pregnant women using KYPROLIS. Carfilzomib caused embryo-fetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS.
Serious adverse reactions were reported in 45% of patients. The most common serious adverse reactions were pneumonia (10%), acute renal failure (4%), pyrexia (3%), and congestive heart failure (3%). Adverse reactions leading to discontinuation of KYPROLIS occurred in 15% of patients and included congestive heart failure (2%), cardiac arrest, dyspnea, increased blood creatinine, and acute renal failure (1% each).
The most common adverse reactions (incidence ≥ 30%) were fatigue (56%), anemia (47%), nausea (45%), thrombocytopenia (36%), dyspnea (35%), diarrhea (33%), and pyrexia (30%).
Since dialysis clearance of KYPROLIS concentrations has not been studied, the drug should be administered after the dialysis procedure.
Full prescribing information is available at http://www.kyprolis.com.
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.
Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.
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 Nexavar® (sorafenib) tablets, Kyprolis® (carfilzomib) for Injection and Stivarga® (regorafenib) tablets. 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 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2013, filed with the Securities and Exchange Commission under the heading "Risk Factors" 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.
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