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THOUSAND OAKS, Calif. , May 26, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced that the Kyprolis Global Economic Model (K-GEM) 1 has been published in the Journal of Medical Economics showing that in the United States (U.S.), Kyprolis ® (carfilzomib) in combination with lenalidomide and dexamethasone (KRd) is cost-effective compared to lenalidomide and dexamethasone (Rd) alone in patients with relapsed or refractory multiple myeloma. The K-GEM demonstrated an incremental cost-effectiveness ratio of $107,250 per Quality-Adjusted Life Year (QALY). Kyprolis provides substantial value when its cost per QALY is contrasted against willingness-to-pay estimates of $150,000-$300,000 per QALY, which are cited as reasonable benchmarks for cancer in the U.S. 2- 4
"Each time a patient with multiple myeloma experiences a relapse, the ability to achieve and sustain a meaningful response to treatment declines, so we continue to seek better ways of treating patients with this complex disease. 5 For the healthcare system, each relapse means the disease burden and cost of care increases," said Andrzej Jakubowiak, M.D., Ph.D., lead author of the manuscript. "The rigorous approach taken in the K-GEM demonstrates the economic value of the KRd regimen over standard of care, with clear evidence of compelling value for patients, payers and society."
The K-GEM incorporated data directly from a head-to-head Phase 3 trial (ASPIRE) in patients with relapsed or refractory multiple myeloma who had received one to three prior therapies. The ASPIRE trial showed that treatment with KRd resulted in a significant improvement (additional 8.6 months) in median progression-free survival (PFS) compared to Rd (26.3 months vs. 17.6 months, hazard ratio for progression or death = 0.69; 95 percent confidence interval [CI]: 0.57 to 0.83; p <0.0001). 6 The most common adverse reactions leading to discontinuation in the KRd arm included pneumonia (1 percent), myocardial infarction (0.8 percent) and upper respiratory tract infection (0.8 percent). A critical assumption in economic models of cancer and also the K-GEM, where trial results have not matured sufficiently to fully characterize the extent of survival, is the extrapolation of overall survival. While a common evidence-based practice in health economics, it should not be considered a claim of extended survival.
About the Kyprolis Global Economic Model The Kyprolis Global Economic Model (K-GEM) provides a robust framework for considering the value of Kyprolis in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. It was co-developed with experts worldwide over a number of years, and has been used as the basis for a number of statutory Health Technology Assessment analyses around the world. The K-GEM incorporated data directly from a comparative Phase 3 trial (ASPIRE) in patients with relapsed multiple myeloma who had received one to three prior therapies.
About ASPIRE The international, randomized Phase 3 ASPIRE (C A rfilzomib, Lenalidomide, and Dexametha S one versus Lenalidomide and Dexamethasone for the treatment of P at I ents with R elapsed Multiple My E loma) trial evaluated Kyprolis in combination with lenalidomide and dexamethasone (KRd), versus lenalidomide and dexamethasone (Rd) alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens. 6 The primary endpoint of the trial was PFS, defined as the time from treatment initiation to disease progression or death. 6 Secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DOR), disease control rate, health-related quality of life (HR-QoL) and safety. 6 Patients were randomized to receive Kyprolis (20 mg/m2 on days 1 and 2 of cycle one only, escalating to 27 mg/m2 on days 8, 9, 15 and 16 of cycle one and continuing on days 1, 2, 8, 9, 15 and 16 of subsequent cycles), in addition to a standard dosing schedule of lenalidomide (25 mg per day for 21 days on, 7 days off) and low-dose dexamethasone (40 mg per week in four-week cycles), versus lenalidomide and low-dose dexamethasone alone. 6 The study randomized 792 patients at sites in North America , Europe and Israel .
About Multiple Myeloma Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. 7 It is a disease that, in 2012, accounted for approximately one percent of all cancers globally. 8,9 In the U.S., there were more than 95,000 people living with, or in remission from, multiple myeloma in 2013. 10
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. 11 Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. 11 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. 11,12 The irreversibility of Kyprolis' binding has also been shown to offer a more sustained inhibition of the targeted enzymes. 12
Kyprolis is approved in the U.S. for the following:
Kyprolis is also approved in Argentina , Israel , Kuwait , Mexico , Thailand , Colombia , Korea, Canada , Switzerland and Russia and the European Union. Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.
For more information, please visit www.kyprolis.com .
Important Safety Information Regarding Kyprolis ® (carfilzomib) for Injection
IMPORTANT SAFETY INFORMATION
Cardiac Toxicities
Acute Renal Failure
Tumor Lysis Syndrome
Pulmonary Toxicity
Pulmonary 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.
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