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Share Name | Share Symbol | Market | Type |
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Amgen Inc | NASDAQ:AMGN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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THOUSAND OAKS, Calif., June 10, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from a post-hoc analysis of the pivotal Phase 3 ASPIRE study which highlighted the benefit of continued treatment with Kyprolis® (carfilzomib) in combination with lenalidomide and dexamethasone (KRd) in patients with relapsed multiple myeloma. Separate sub-analyses of the Phase 3 ENDEAVOR study further confirmed efficacy and depth of response benefits of Kyprolis plus dexamethasone (Kd). These results were presented at the 21st Congress of the European Hematology Association (EHA).
Results from the ASPIRE analysis showed that cumulative rates of complete response or better (>CR) continued to increase over time in the KRd arm, most quickly in the first 15 months of treatment. In addition, the progression-free survival (PFS) hazard ratio (HR) at 18 months was 0.58 (95 percent CI: 0.46-0.72), while the overall study HR at 31 months was 0.69 (95 percent CI: 0.57-0.83), possibly related to patients in the KRd arm receiving Kyprolis for a maximum of 18 months (EHA abstract #P275). Researchers assessed PFS HR at 18 months following discontinuation of Kyprolis treatment in the KRd arm per the trial protocol. The most common all grade treatment-related adverse events in the ASPIRE trial included neutropenia (34.2 percent), anemia (25.5 percent), fatigue (22.4 percent) and thrombocytopenia (22.4 percent).
Six additional abstracts presented at EHA further demonstrate the benefit of Kyprolis-based regimens across a range of patient populations:
"This week's presentations at EHA continue to confirm that compared to previous standard of care therapies, across patient populations and therapeutic combinations, treatment with Kyprolis can extend the time patients live without their disease progressing," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This abundant clinical research provides substantive, meaningful evidence for Kyprolis as a foundational therapy for relapsed or refractory multiple myeloma patients."
Abstracts are currently available on the EHA website.
EHA Abstract #P275:
Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients with Relapsed Multiple Myeloma: Analysis of Response and Progression-Free Survival Hazard Ratio Over Time
In this post-hoc analysis of data from the Phase 3 ASPIRE trial, researchers evaluated the time to cumulative >CR and PFS HR at 18 months from randomization for KRd-treated patients (n=396) versus Rd-treated patients (n=396). KRd and Rd patients were followed for a median of 31 and 30 months for PFS, respectively. Per trial protocol, Kyprolis was discontinued after 18 cycles (28 days/cycle), so optimal duration of KRd treatment was not determined. All patients continued to receive Rd treatment until disease progression.
EHA Abstract #E1266: Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone: Subgroup Analysis of the Phase 3 ENDEAVOR Study to Evaluate the Impact of Prior Treatment on Patients with Relapsed Multiple Myeloma
This subgroup analysis evaluated treatment with Kd versus Vd in patients after first relapse versus more than two prior lines of therapy, as well as the effect of previous exposure to bortezomib or lenalidomide.
EHA Abstract #E1267: Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone: Subgroup Analysis of Patients with Relapsed Multiple Myeloma by Baseline Cytogenetic Risk Status (Phase 3 ENDEAVOR Study)
This pre-planned subgroup analysis evaluated the efficacy and safety outcomes in patients treated with Kd versus Vd according to patients' baseline cytogenetic risk status.
EHA Abstract #E1274: Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Relapsed Multiple Myeloma: Analysis of the Phase 3 ENDEAVOR Study by Age Subgroup
This pre-planned subgroup analysis evaluated results of the ENDEAVOR study according to patients' age (younger than 65, 65-74, and 75 and older). Of the 929 patients enrolled, 223 patients received Kd and 210 received Vd in the <65 years subgroup; 164 patients received Kd and 189 received Vd in the 65-74 years subgroup; and 77 patients received Kd and 66 received Vd in the ≥75 years subgroup.
EHA Abstract #E1328: Outcomes for Asian Patients With Relapsed Multiple Myeloma Treated With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone: A Subgroup Analysis of the Phase 3 ENDEAVOR Study
This pre-planned subgroup analysis evaluated the efficacy and safety outcomes in Asian patients (n=109) with relapsed multiple myeloma from the ENDEAVOR study. The majority of patients were from Japan (n=44; 40.4 percent), followed by Taiwan (n=24; 22.0 percent), Singapore (n=20; 18.3 percent), Republic of Korea (n=16; 14.7 percent), and Thailand (n=5; 4.6 percent).
EHA Abstract #P659: Carfilzomib and Dexamethasone Versus Subcutaneous Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma: Secondary Analysis from the Phase 3 Study ENDEAVOR
This subset analysis assessed the efficacy and safety of Kd compared to subcutaneous (SC) delivery of Vd, consistent with current standard of care, and the effect of prior exposure to bortezomib. The analysis compared Kd patients who had selected SC bortezomib delivery pre-randomization if randomized to the Vd arm (n=356) with Vd patients who used SC bortezomib (n=360).
EHA Abstract #P663: Efficacy and Safety by Cytogenetic Risk Status: Phase 3 Study (ASPIRE) of Carfilzomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients with Relapsed Multiple Myeloma
This pre-planned subgroup analysis assessed the efficacy and safety of KRd compared with lenalidomide and dexamethasone (Rd) according to baseline cytogenetic risk status in patients with relapsed multiple myeloma who had received one to three prior lines of therapy.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and very aggressive disease that accounts for approximately one percent of all cancers.2-4 In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year and 24,000 patient deaths are reported on an annual basis.2 Worldwide, more than 230,000 people are living with multiple myeloma.2
About Amgen's Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen's supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.
About Kyprolis® (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.5 Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.5 In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.5,6
Kyprolis is approved in the U.S. for the following:
Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada, Switzerland, Russia and the European Union. Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan.
For more information on Kyprolis in the U.S. please visit www.kyprolis.com.
Important EU Product Safety Information
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy. The most serious side effects that may occur during Kyprolis treatment include: Cardiac toxicity, pulmonary toxicities, pulmonary hypertension, dyspnea, hypertension including hypertensive crises, acute renal failure, tumor lysis syndrome, infusion reactions, thrombocytopenia, hepatic toxicity, posterior reversible encephalopathy syndrome (PRES) and thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS). The most common side effects are anemia, fatigue, diarrhea, thrombocytopenia, nausea, pyrexia, dyspnea, respiratory tract infection, cough and peripheral edema.
Please refer to the Summary of Product Characteristics for full European prescribing information.
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
INDICATION(S)
IMPORTANT U.S. SAFETY INFORMATION
Cardiac Toxicities
Acute Renal Failure
Tumor Lysis Syndrome
Pulmonary Toxicity
Pulmonary Hypertension
Dyspnea
Hypertension
Venous Thrombosis
Infusion Reactions
Thrombocytopenia
Hepatic Toxicity and Hepatic Failure
Thrombotic Microangiopathy
Posterior Reversible Encephalopathy Syndrome (PRES)
Embryo-fetal Toxicity
ADVERSE REACTIONS
Please see full Prescribing Information at www.kyprolis.com.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Forward Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration or the European Medicines Agency for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (Media)
Kristen Neese, 805-313-8267 (Media)
Arvind Sood, 805-447-1060 (Investors)
References
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-analyses-from-pivotal-phase-3-studies-show-kyprolis-carfilzomib-allows-patients-with-relapsed-multiple-myeloma-to-live-longer-without-disease-progression-300283159.html
SOURCE Amgen
Copyright 2016 PR Newswire
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