THOUSAND OAKS, Calif. and
观看比赛直播 SOUTH SAN FRANCISCO, Calif.,
观看比赛直播 FIFA 2026开球时间 March 1, 2015 世界杯直播频道 /PRNewswire/ --
世界杯直播频道 世界杯直播频道 Amgen (NASDAQ: AMGN) and its subsidiary
世界杯直播频道 Onyx Pharmaceuticals, Inc., today announced the results from 世界杯直播频道 a planned interim analysis showing that the Phase 观看比赛直播 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis® (carfilzomib)
for Injection in combination with low-dose dexamethasone versus Velcade® (bortezomib) and low-dose dexamethasone met the primary endpoint of progression-free survival (PFS). Patients with
世界杯直播频道 观看比赛直播 观看比赛直播 relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clinically significant 世界杯直播频道 superiority over Velcade (median PFS 18.7 months
versus 9.4 months, HR=0.53, 95 percent CI, 0.44 – 0.65).
The Kyprolis combination demonstrated FIFA 2026开球时间 superiority over 世界杯直播频道 the 观看比赛直播 Velcade 世界杯直播频道 combination for secondary objectives of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature
世界杯直播频道 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 and continue to be monitored.
Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in
FIFA 2026开球时间 世界杯直播频道 the Phase 3 ASPIRE study. In ENDEAVOR, the rates for cardiac and renal failure were higher in the 世界杯直播频道 Kyprolis arm versus the Velcade arm. There was an increase in the incidence of hypertension and dyspnea
in the Kyprolis arm compared to Velcade and that observed in the FIFA 2026开球时间 ASPIRE study.
Full 世界杯直播频道 data will be submitted for presentation at the
世界杯直播频道 American Society of Clinical Oncology 2015 Annual Meeting.
"We are excited FIFA 2026开球时间 about the results with Kyprolis FIFA 2026开球时间 in the ENDEAVOR and FIFA 2026开球时间 ASPIRE studies and the 世界杯直播频道 potential positive impact for patients with relapsed multiple myeloma," said
FIFA 2026开球时间 Robert A. Bradway, chairman and chief executive officer at Amgen.
"As new treatment options become available FIFA 2026开球时间 to patients with relapsed 世界杯直播频道 multiple myeloma, comparative trials, like ENDEAVOR, are becoming 世界杯直播频道 increasingly important to help physicians make informed decisions about
世界杯直播频道 FIFA 2026开球时间 the optimal care for patients," said
观看比赛直播 FIFA 2026开球时间 观看比赛直播 FIFA 2026开球时间 Pablo J. Cagnoni, M.D., president,
Onyx Pharmaceuticals, Inc. "Demonstrating superiority over Velcade in this head-to-head trial supports our goal of ensuring continued improvement of patient outcomes and potentially establishing
FIFA 2026开球时间 Kyprolis as the backbone of therapy for patients with multiple myeloma."
The ENDEAVOR study is the first of two head-to-head studies for Kyprolis versus Velcade, an established FIFA 2026开球时间 proteasome inhibitor, currently approved to treat multiple myeloma.
About ENDEAVOR
The randomized ENDEAVOR (RandomizEd, OpeN FIFA 2026开球时间 Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib
Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial of 929 patients evaluated Kyprolis in 世界杯直播频道 combination with FIFA 2026开球时间 low-dose 观看比赛直播 dexamethasone, versus Velcade with low-dose
FIFA 2026开球时间 观看比赛直播 世界杯直播频道 观看比赛直播 世界杯直播频道 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 was PFS, defined as the time from
FIFA 2026开球时间 世界杯直播频道 观看比赛直播 FIFA 2026开球时间 世界杯直播频道 treatment FIFA 2026开球时间 initiation to disease progression or death.
Patients received Kyprolis as a 30 世界杯直播频道 minute infusion along with low-dose FIFA 2026开球时间 dexamethasone 世界杯直播频道 (20 mg). For Cycle 1 only, 观看比赛直播 Kyprolis was administered at 20 mg/m2 on days 1 观看比赛直播 and 2, followed by escalation to
观看比赛直播 观看比赛直播 FIFA 2026开球时间 56 mg/m2 on days 8, 9, 15, and 16. Patients who tolerated 56 mg/m2 in FIFA 2026开球时间 Cycle 1 were kept at this dose for subsequent cycles on days 1, 2, 8, 9, 15, and 16 on a 28 day cycle. Patients
FIFA 2026开球时间 who received Velcade (1.3 mg/m2) with low-dose dexamethasone (20 mg) were administered Velcade subcutaneously or intravenously at the discretion of the investigator and in 观看比赛直播 世界杯直播频道 accordance with
观看比赛直播 世界杯直播频道 世界杯直播频道 regulatory approval of Velcade. More than 75 percent of the patients in the control arm received Velcade subcutaneously. This study was conducted at 235 sites worldwide. For 观看比赛直播 information about this trial,
世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 观看比赛直播 please visit http://www.clinicaltrials.gov/ under trial identification number NCT01568866.
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. Worldwide, nearly 230,000 people
世界杯直播频道 FIFA 2026开球时间 are living with multiple myeloma,1 approximately FIFA 2026开球时间 114,000 new cases were diagnosed and 80,000 people died in 2012.2 In the U.S., approximately 83,000 people are living with FIFA 2026开球时间 multiple
世界杯直播频道 myeloma and more than 22,000 new 世界杯直播频道 cases were diagnosed and more 观看比赛直播 than 10,000 people died in 2013.3 In
FIFA 2026开球时间 世界杯直播频道 世界杯直播频道 Europe, approximately 89,000 people are living with multiple myeloma,1 approximately 42,000 new cases 世界杯直播频道 were FIFA 2026开球时间 diagnosed and approximately 26,000 people died in 2012.1,2
About Kyprolis® (carfilzomib) for Injection
On
世界杯直播频道 FIFA 2026开球时间 July 20, 2012, the U.S.
FDA granted accelerated approval of Kyprolis for the treatment of patients with multiple myeloma who have received at least two prior 世界杯直播频道 therapies including bortezomib and an immunomodulatory agent
世界杯直播频道 观看比赛直播 (IMiD) and have demonstrated disease progression on or 世界杯直播频道 within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms,
FIFA 2026开球时间 has not been verified. Kyprolis is administered intravenously over 2 to 10 minutes, on two consecutive days each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days
FIFA 2026开球时间 世界杯直播频道 17 to 28) at a recommended Cycle 1 dose of 20 mg/m2/day and if tolerated increased Cycle 2 dose and subsequent cycles doses of 27 mg/m2/day.
Kyprolis is also approved for use in
世界杯直播频道 世界杯直播频道 Argentina,
观看比赛直播 FIFA 2026开球时间 世界杯直播频道 世界杯直播频道 Mexico and
世界杯直播频道 世界杯直播频道 Israel.
Kyprolis is marketed in the U.S. by
FIFA 2026开球时间 FIFA 2026开球时间 Onyx Pharmaceuticals, Inc., an
世界杯直播频道 世界杯直播频道 观看比赛直播 FIFA 2026开球时间 Amgen subsidiary.
Kyprolis is a product of
FIFA 2026开球时间 Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals is a subsidiary of
Amgen and FIFA 2026开球时间 holds 世界杯直播频道 development and commercialization rights to Kyprolis globally, excluding
世界杯直播频道 FIFA 2026开球时间 Japan. For more information about Kyprolis, visit http://www.kyprolis.com/.
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
Safety FIFA 2026开球时间 data have FIFA 2026开球时间 been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who
世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 世界杯直播频道 received single-agent Kyprolis. FIFA 2026开球时间 There were 37 deaths in the Phase 2 studies, or 7 percent of patients. The most common causes of death, other than disease progression, were cardiac events 观看比赛直播 (5 patients),
世界杯直播频道 世界杯直播频道 end-organ failure (4 patients) and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia, pulmonary hypertension, pulmonary
观看比赛直播 complications, infusion reactions, tumor lysis syndrome, 世界杯直播频道 thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New FIFA 2026开球时间 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 FIFA 2026开球时间 cardiac complications.
Pulmonary 观看比赛直播 arterial hypertension (PAH) was reported in 2 世界杯直播频道 percent of patients treated with Kyprolis and was Grade 3 or greater in less than 1 percent of patients. Dyspnea was reported in 世界杯直播频道 35 percent of patients
FIFA 2026开球时间 世界杯直播频道 enrolled in FIFA 2026开球时间 clinical trials. Grade 世界杯直播频道 3 dyspnea occurred in 5 percent; no Grade 世界杯直播频道 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, 世界杯直播频道 vomiting, weakness, shortness of breath, hypotension, syncope,
FIFA 2026开球时间 chest 世界杯直播频道 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 FIFA 2026开球时间 severity of
FIFA 2026开球时间 reactions. Tumor FIFA 2026开球时间 lysis syndrome (TLS) occurred following Kyprolis administration in <1 世界杯直播频道 percent FIFA 2026开球时间 of patients. Patients with multiple myeloma and a high 世界杯直播频道 tumor burden should be considered to be at greater
FIFA 2026开球时间 risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1 percent of patients and discontinuation of treatment 世界杯直播频道 with Kyprolis in <1 percent of patients.
Cases of hepatic failure, including fatal cases, have been reported 世界杯直播频道 (<1 世界杯直播频道 percent). Kyprolis can cause elevations of serum transaminases and bilirubin.
There are no adequate and well-controlled studies in 世界杯直播频道 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 percent or greater) observed in clinical
观看比赛直播 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, 世界杯直播频道 dyspnea, 世界杯直播频道 diarrhea and pyrexia. Serious adverse reactions were reported in 45 percent of patients.
Full prescribing information is available at http://www.kyprolis.com/.
About Amgen
Amgen is committed to unlocking the potential FIFA 2026开球时间 of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering FIFA 2026开球时间 innovative human therapeutics. This
FIFA 2026开球时间 approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen 世界杯直播频道 focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
FIFA 2026开球时间 FIFA 2026开球时间 观看比赛直播 A biotechnology FIFA 2026开球时间 pioneer since 1980,
FIFA 2026开球时间 世界杯直播频道 Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is 观看比赛直播 developing a pipeline of medicines with breakaway
观看比赛直播 世界杯直播频道 观看比赛直播 世界杯直播频道 potential.
世界杯直播频道 FIFA 2026开球时间
For more information, visit http://www.amgen.com/ and follow us on www.twitter.com/amgen.
About Onyx Pharmaceuticals, Inc.
Based in
FIFA 2026开球时间 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 South San Francisco, California,
世界杯直播频道 FIFA 2026开球时间 观看比赛直播 Onyx Pharmaceuticals, Inc., an
世界杯直播频道 观看比赛直播 世界杯直播频道 Amgen subsidiary, 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
世界杯直播频道 世界杯直播频道 世界杯直播频道 FIFA 2026开球时间 on developing novel medicines 观看比赛直播 that target key molecular pathways. For more information about Onyx, visit the company's website at http://www.onyx.com/.
Onyx Pharmaceuticals is on Twitter. Sign up 世界杯直播频道 to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.
Forward-Looking Statements
This news release contains 世界杯直播频道 forward-looking statements that are based on the current expectations and beliefs FIFA 2026开球时间 of
FIFA 观看比赛直播 2026开球时间 FIFA 2026开球时间 观看比赛直播 Amgen Inc. and its subsidiaries (
FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 Amgen) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical
FIFA 2026开球时间 观看比赛直播 FIFA 2026开球时间 观看比赛直播 世界杯直播频道 fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital 观看比赛直播 expenditures, cash, 观看比赛直播 other financial metrics, expected legal, arbitration,
FIFA 2026开球时间 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 观看比赛直播 the
世界杯直播频道 观看比赛直播 Securities and Exchange Commission (
FIFA 2026开球时间 FIFA 2026开球时间 世界杯直播频道 SEC) reports filed by
Amgen Inc., including
FIFA 2026开球时间 世界杯直播频道 Amgen Inc.'s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 观看比赛直播 8-K. Please 世界杯直播频道 refer to
FIFA 2026开球时间 FIFA 2026开球时间 FIFA 2026开球时间 Amgen 观看比赛直播 Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to
FIFA 2026开球时间 世界杯直播频道 Amgen's business. Unless otherwise 世界杯直播频道 noted,
世界杯直播频道 观看比赛直播 Amgen is providing this information as of
观看比赛直播 FIFA 2026开球时间 March 1, 2015 and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ 世界杯直播频道 materially from those
FIFA 2026开球时间 FIFA 2026开球时间 Amgen 世界杯直播频道 projects. 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;
观看比赛直播 观看比赛直播 consequently, there can be no 世界杯直播频道 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 世界杯直播频道 human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell
世界杯直播频道 世界杯直播频道 culture systems FIFA 2026开球时间 or animal models. The length of time that it takes for
FIFA 2026开球时间 观看比赛直播 世界杯直播频道 Amgen and its partners to complete clinical trials and obtain regulatory approval for product 世界杯直播频道 marketing has in the past varied and
世界杯直播频道 Amgen expects similar variability in the future.
FIFA 2026开球时间 FIFA 2026开球时间 Amgen develops product candidates internally and through licensing FIFA 2026开球时间 collaborations, partnerships and FIFA 2026开球时间 joint ventures. Product candidates that are derived from relationships may be subject to disputes
FIFA 2026开球时间 FIFA 2026开球时间 between the parties or may prove to be 观看比赛直播 not as effective or as safe as
FIFA 2026开球时间 FIFA 2026开球时间 Amgen may have believed at the time of entering into such relationship. Also,
世界杯直播频道 Amgen or others could identify FIFA 2026开球时间 safety, side FIFA 2026开球时间 effects or manufacturing problems with
世界杯直播频道 Amgen's products after they are on the market.
观看比赛直播 FIFA 2026开球时间 Amgen's business may be impacted by government investigations, litigation and product liability claims. If
世界杯直播频道 FIFA 2026开球时间 FIFA 2026开球时间 Amgen fails to meet the compliance obligations in the corporate integrity FIFA 2026开球时间 agreement between
FIFA 2026开球时间 Amgen and the FIFA 2026开球时间 U.S. government,
世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 Amgen could become subject to significant sanctions.
世界杯直播频道 FIFA 2026开球时间 世界杯直播频道 Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain 观看比赛直播 sales of certain
世界杯直播频道 世界杯直播频道 观看比赛直播 FIFA 2026开球时间 观看比赛直播 观看比赛直播 观看比赛直播 of its current products and product candidate development.
In addition, sales of
FIFA 2026开球时间 Amgen's products (including products of
世界杯直播频道 Amgen's wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers FIFA 2026开球时间 and may be
FIFA 2026开球时间 FIFA 2026开球时间 affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and 世界杯直播频道 healthcare cost containment as well as U.S. legislation affecting pharmaceutical
世界杯直播频道 pricing and reimbursement. Government and others' regulations 观看比赛直播 and reimbursement policies may affect the development, usage and pricing of
世界杯直播频道 FIFA 2026开球时间 Amgen's products. In addition,
观看比赛直播 FIFA 2026开球时间 Amgen competes with other companies with respect to some of its marketed products as well as 世界杯直播频道 for the discovery and development of new products.
Amgen believes that some of 世界杯直播频道 its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and FIFA 2026开球时间 marketed.
FIFA 2026开球时间 世界杯直播频道 FIFA 2026开球时间 Amgen's products may compete against 观看比赛直播 products that have lower prices, established reimbursement, superior performance, are easier to administer, or FIFA 2026开球时间 that are FIFA 2026开球时间 otherwise competitive with its products.
FIFA 2026开球时间 世界杯直播频道 In addition, while
FIFA 2026开球时间 世界杯直播频道 Amgen and its partners routinely obtain patents for their products and technology, the protection of
FIFA 2026开球时间 FIFA 2026开球时间 Amgen's products offered by patents and patent applications may be challenged, invalidated or circumvented by its competitors and FIFA 2026开球时间 there can be no guarantee of
FIFA 2026开球时间 FIFA 2026开球时间 Amgen's or its partners' ability to obtain or maintain patent protection for
FIFA 2026开球时间 FIFA 2026开球时间 Amgen's products or product candidates.
观看比赛直播 世界杯直播频道 Amgen cannot guarantee that it will be able to produce commercially successful products or maintain 世界杯直播频道 the commercial success 观看比赛直播 of its existing products.
FIFA 2026开球时间 世界杯直播频道 Amgen's stock price may be affected by actual or 观看比赛直播 perceived market opportunity, competitive position and success or failure of its products or 观看比赛直播 product candidates. FIFA 2026开球时间 Further, the discovery of significant
世界杯直播频道 世界杯直播频道 世界杯直播频道 problems FIFA 2026开球时间 with a product similar to one of
FIFA 2026开球时间 Amgen's products that 世界杯直播频道 implicate an entire class FIFA 2026开球时间 of 世界杯直播频道 products could have FIFA 2026开球时间 a material adverse effect on sales of the affected products and on
Amgen's business and results of operations.
FIFA 2026开球时间 Amgen's efforts to integrate the operations of companies it has acquired may not be successful. Cost saving initiatives FIFA 2026开球时间 may result in
世界杯直播频道 FIFA 2026开球时间 Amgen incurring impairment or other related charges on its assets.
FIFA 2026开球时间 Amgen may experience difficulties, delays or unexpected costs and not achieve anticipated cost savings from its recently announced restructuring plan.
观看比赛直播 FIFA 2026开球时间 Amgen's business performance could affect or limit the ability of
世界杯直播频道 世界杯直播频道 Amgen's Board of Directors to declare a dividend or their ability to pay a dividend or repurchase
FIFA 2026开球时间 世界杯直播频道 Amgen common stock.
The scientific information discussed in this news release relating to new indications for
世界杯直播频道 观看比赛直播 FIFA 2026开球时间 Amgen's products is preliminary and investigative and is not part of the labeling 观看比赛直播 approved by the
FIFA 2026开球时间 U.S. Food and Drug Administration (
FIFA 2026开球时间 FDA) for the products. The products FIFA 2026开球时间 are 观看比赛直播 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
世界杯直播频道 of the products for these uses.
Velcade® (bortezomib) is a registered trademark of
观看比赛直播 Millennium Pharmaceuticals, Inc.
CONTACT:
观看比赛直播 观看比赛直播 FIFA 2026开球时间 世界杯直播频道 Amgen,
世界杯直播频道 世界杯直播频道 世界杯直播频道 Thousand Oaks
Kristen Davis, 805-447-3008 (
观看比赛直播 FIFA 2026开球时间 观看比赛直播 Amgen media)
Lindsay Treadway, 650-266-5346 (Onyx media)
Arvind Sood, 805-447-1060 (investors)
References
1 Bray F, Ren JS, Masuyer 观看比赛直播 E, Ferlay J. Estimates of global FIFA 2026开球时间 cancer prevalence for 27 sites in the adult 观看比赛直播 population in 2008. Int J Cancer. 2013
FIFA 2026开球时间 Mar. 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 世界杯直播频道 26.
2 Ferlay J, et al. GLOBOCAN 世界杯直播频道 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet].
世界杯直播频道 观看比赛直播 Lyon, France:
世界杯直播频道 FIFA 2026开球时间 International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on 15/January/2015.
世界杯直播频道 FIFA 2026开球时间
3
National Cancer Institute. SEER Stat Fact FIFA 观看比赛直播 2026开球时间 Sheets: Myeloma. http://seer.cancer.gov/statfacts/html/mulmy.html.
观看比赛直播
