Onyx Pharmaceuticals Announces Data Presentations at 48th American Society of Clinical Oncology Annual Meeting

SOUTH SAN FRANCISCO, Calif., May 16, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the upcoming presentations of data highlighting Nexavar® (sorafenib) tablets, Kyprolis™ (proposed trademark for carfilzomib) and regorafenib, a Bayer-owned compound for which Onyx will receive a royalty on global net sales.  These presentations will take place at the 48th American Society of Clinical Oncology (ASCO) Annual Meeting, June 1-5, 2012, in Chicago, IL.

"The data being presented at ASCO demonstrates Onyx's commitment to bringing innovative treatment options to cancer patients, and we are excited to share this breadth of data across a range of cancers," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals.

Regorafenib

Randomized Phase III trial of regorafenib in patients (pts) with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) progressing despite prior treatment with at least imatinib (IM) and sunitinib (SU) – GRID trial

• Dr. George D. Demetri, Dana Farber Cancer Institute, United States
• Monday, June 4, 2012
• Oral presentation: 5:30 PM – 5:45 PM, S406
• Oral abstract session – Sarcoma
• Abstract #LBA10008

Phase III CORRECT trial of regorafenib in metastatic colorectal cancer (mCRC)

• Dr. Eric Van Cutsem, University of Leuven and Gasthuisberg University Hospital, Leuven, Belgium
• Sunday, June 3, 2012
• Oral presentation: 10:15 AM – 10:30 AM, E Hall D1
• Oral abstract session – Gastrointestinal (Colorectal) Cancer
• Abstract #3502

Regorafenib 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. 

Kyprolis™ (proposed trademark for carfilzomib)

Response rates to single-agent carfilzomib in patients refractory or intolerant to both bortezomib and immunomodulators in trial PX-171-003-A1

• Dr. David S. Siegel, Hackensack University Medical Center, United States
• Saturday, June 2, 2012
• Poster viewing: 8:00 AM - 12:00 PM, E450b
• Poster discussion: 12:00 PM-1:00 PM, E354a
• Poster discussion session –  Lymphoma and Plasma Cell Disorders, Poster #15
• Abstract #8035

Phase I/II study of carfilzomib plus melphalan-prednisone (CMP) in elderly patients with de novo multiple myeloma

• Dr. Brigitte Kolb, University Hospital, Nantes, France
• Sunday, June 3, 2012
• Oral presentation: 8:00 AM - 8:15 AM, E354a
• Oral Abstract Session - Myeloma
• Abstract #8009

A Phase I/II trial of cyclophosphamide, carfilzomib, thalidomide and dexamethasone (CYCLONE) in patients with newly diagnosed multiple myeloma

• Dr. Joseph Mikhael, Mayo Clinic, United States
• Sunday, June 3, 2012
• Oral presentation: 8:15 AM - 8:30 AM, E354a
• Oral Abstract Session - Myeloma
• Abstract #8010

Stringent complete response (sCR) in patients (pts) with newly diagnosed multiple myeloma (NDMM) treated with carfilzomib (CFZ), lenalidomide (LEN), and dexamethasone (DEX)

• Dr. Andrzej J. Jakubowiak, University of Chicago, United States
• Sunday, June 3, 2012
• Oral presentation: 8:30 AM - 8:45 AM, E354a
• Oral Abstract Session – Myeloma
• Abstract #8011

Hematologic safety data from four phase II studies of single-agent carfilzomib in relapsed and/or refractory multiple myeloma

• Dr. Ajay K. Nooka,  Emory University School of Medicine, United States
• Monday, June 4, 2012
• Poster time: 1:15 PM - 5:15 PM, S Hall A2
• General poster session – Lymphoma and Plasma Cell Disorders, Poster #37C
• Abstract #8086

A phase I/II study of carfilzomib (CFZ) as a replacement for bortezomib (BTZ) for multiple myeloma (MM) patients (Pts) progressing while receiving a BTZ-containing combination regimen

• Dr. James R. Berenson, Institute for Myeloma and Bone Cancer Research (IMBCR), United States
• Monday, June 4, 2012
• Poster time: 1:15 PM - 5:15 PM, S Hall A2
• General poster session – Lymphoma and Plasma Cell Disorders, Poster #38G
• Abstract #8098

A single-arm, open-label, multicenter phase I/II study of the combination of panobinostat (pan) and carfilzomib (cfz) in patients (pts) with relapsed/refractory multiple myeloma (RR MM)

• Dr. Jesus G. Berdeja, Sarah Cannon Research Institute, United States
• Monday, June 4, 2012
• Poster time: 1:15 PM - 5:15 PM, S Hall A2
• General poster session – Lymphoma and Plasma Cell Disorders, Poster #40H
• Abstract #TPS8115

Nexavar® (sorafenib) tablets

A Phase II trial of MEK inhibitor BAY 86-9766 in combination with sorafenib as first-line systemic treatment for patients with unresectable hepatocellular carcinoma (HCC)

• Dr. Ho Yeong Lim, Sungkyunkwan University School of Medicine, Korea
• Monday, June 4, 2012
• Poster viewing: 8:00 AM – 12:00 PM, S Hall A2
• General poster session – Gastrointestinal (Noncolorectal) Cancer, Poster #48F
• Abstract #4103

About the Kyprolis™ (proposed trademark 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.

A new drug application (NDA) for Kyprolis for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies is currently being reviewed by the U.S. FDA, and the anticipated date for completion of review is July 27, 2012. The NDA submission is based on the Kyprolis 003-A1 study, an open-label, single-arm Phase 2b trial, as well as safety data from additional studies.

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 3 clinical trial, called ENDEAVOR, is planned to begin enrolling patients in mid-2012.  The head-to-head trial will evaluate the combination of Kyprolis and low-dose dexamethasone vs. the combination of bortezomib and low-dose dexamethasone. 
• 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 Nexavar (sorafenib) tablets

Nexavar is approved in the U.S. for the treatment of patients with unresectable liver cancer and for the treatment of patients with advanced kidney cancer. Nexavar inhibits both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to inhibit members of two classes of kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is currently approved in more than 100 countries.

Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators.

Important Safety Considerations for Patients Taking Nexavar

Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer. Nexavar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential are advised to avoid becoming pregnant and female patients should also be advised against breastfeeding while receiving Nexavar.

Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction. Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar.

Uncommon but serious adverse reactions, including keratoacanthomas/squamous cell cancer of the skin and Stevens-Johnson Syndrome, have been reported in clinical trials.

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar. Hypertension may occur early in the course of treatment.  Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required.

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures. Nexavar can prolong the QT/QTc interval and increase the risk for ventricular arrhythmias.  Avoid use in patients with congenital long QT syndrome and monitor patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar.  Monitor patients taking concomitant warfarin regularly for changes in prothrombin time, INR, or clinical bleeding episodes.  Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of sorafenib.  Nexavar exposure decreases when co-administered with oral neomycin.  Effects of other antibiotics on Nexavar pharmacokinetics have not been studied.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in unresectable HCC, respectively, were: diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and hand-foot skin reaction (21% vs 3%). Grade 3/4 adverse reactions were 45% vs 32%.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in advanced RCC, respectively, were: diarrhea (43% vs 13%), rash/desquamation (40% vs 16%), fatigue (37% vs 28%), hand-foot skin reaction (30% vs 7%), alopecia (27% vs 3%),and nausea (23% vs 19%). Grade 3/4 adverse reactions were 38% vs 28%. During postapproval use of Nexavar, the following adverse drug reactions have been identified: angioedema and drug-induced hepatitis, including reports of hepatic failure and death.

For information about Nexavar including U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).

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.

Nexavar® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc. ("Bayer")

Kyprolis is the proposed trade name for carfilzomib.

Regorafenib is a compound under development by Bayer; Onyx will receive a royalty on potential future global net sales in human oncology and will co-promote with Bayer in the U.S.

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 potential expansion of Onyx's product portfolio, the possibility of royalty payments to Onyx from the sale of regorafenib, and the timing, progress and results of clinical development and the regulatory approval process. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: Nexavar being our only approved product; we may never receive marketing approval for Kyprolis (carfilzomib) or regorafenib; competition; failures or delays in our clinical trials or the regulatory process; dependence on our collaborative relationship with Bayer; if approved, we or Bayer, as the case may be, may be unsuccessful in launching, maintaining adequate supply of or obtaining reimbursement for Kyprolis or regorafenib; market acceptance and the rate of adoption of our products; pharmaceutical pricing and reimbursement pressures; serious adverse side effects, if they are associated with Nexavar, regorafenib or Kyprolis; government regulation; possible failure to realize the anticipated benefits of business acquisitions or strategic investments; protection of our intellectual property; the indebtedness incurred through the sale of our 4.0% convertible senior notes due 2016; and product liability risks. 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, as updated by Onyx's subsequent Quarterly Reports on Form 10-Q, under the heading "Risk Factors" for a more detailed description of these and other risks. 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.

SOURCE Onyx Pharmaceuticals, Inc.

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