THOUSAND OAKS, Calif., Dec. 5, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new key data evaluating Kyprolis® (carfilzomib) -based regimens in patients with relapsed multiple myeloma. The data showed Kyprolis in combination with dexamethasone significantly extended disease progression compared to bortezomib plus dexamethasone across a range of difficult-to-treat populations, specifically those with high risk and previously treated disease. The analyses were presented during the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, Fla.
Data analyzed in three presentations across patient subgroups from the Phase 3 ENDEAVOR trial showed that patients with relapsed or refractory multiple myeloma, who were treated with Kyprolis plus dexamethasone, achieved superior progression-free survival (PFS) compared to those receiving bortezomib plus dexamethasone. The subgroup analyses evaluated the Kyprolis combination based on prior treatment, cytogenetic risk status and age, respectively (ASH abstracts #729, #30 and #1844). Pivotal data from the Phase 3 ENDEAVOR trial were previously presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) and published online in The Lancet Oncology today.
A separate presentation analyzed the efficacy and safety of Kyprolis according to baseline cytogenetic risk status, based on data from the Phase 3 ASPIRE trial in which Kyprolis in combination with lenalidomide and dexamethasone demonstrated a significant improvement in PFS compared to lenalidomide and dexamethasone (ASH abstract #731).
"Our clinical research with Kyprolis aims to improve outcomes for patients in the relapsed setting, which are currently poor due to more aggressive disease biology as multiple myeloma progresses," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This week's presentations show that even in difficult-to-treat populations, Kyprolis significantly extends the time patients can live without their disease progressing and improves the depth and duration of a response, compared to current standard of care therapies."
Multiple myeloma is characterized by very complex cytogenetic and molecular genetic aberrations.1 Cytogenetic analysis may provide more information about myeloma prognosis and help physicians with treatment plans.2 Myeloma cytogenetic analysis is an examination of the bone marrow cells to look for chromosome abnormalities.2
Abstracts are currently available on the ASH website.
ASH Abstract #729: Impact of Prior Treatment on Patients with Relapsed Multiple Myeloma Treated with Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone in a Subgroup Analysis of the Phase 3 ENDEAVOR Study (NCT01568866)
This preplanned, exploratory sub-analysis assessed treatment with Kyprolis and dexamethasone or bortezomib and dexamethasone in 929 total patients. The proportion of patients with one prior therapy compared to those with two or more prior lines of therapy was balanced between the treatment arms. The proportion of patients with prior bortezomib or lenalidomide exposure was also balanced across treatment arms within the subgroups of patients with one or two or more prior lines of therapy. The analysis demonstrated a favorable benefit-risk profile of Kyprolis regardless of prior treatment, including number and types of prior therapy.
- Median PFS for patients after one prior line of therapy was 22.2 months (95 percent CI, 17.7not estimable [NE]) for the Kyprolis-containing regimen versus 10.1 months (95 percent CI, 8.812.7) for the bortezomib-containing regimen (HR: 0.45). Median PFS for patients who had two or more previous lines of therapy was 14.9 months (10.2NE) for Kyprolis patients compared with 8.4 months (6.510.2) for bortezomib patients (HR: 0.60).
- Grade 3 or higher adverse events were reported in 69.8 percent of Kyprolis patients and 63.9 percent of bortezomib patients previously treated with one prior line, and 76.6 percent of Kyprolis patients and 69.9 percent of bortezomib patients with two or more prior lines.
ASH Abstract #30: Efficacy and Safety of Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Relapsed Multiple Myeloma Based on Cytogenetic Risk Status: Subgroup Analysis from the Phase 3 Study ENDEAVOR (NCT01568866)
In this preplanned, exploratory sub-analysis of the efficacy and safety of Kyprolis and dexamethasone versus bortezomib and dexamethasone based on baseline cytogenetic risk status, Kyprolis demonstrated superiority to bortezomib and a favorable benefitrisk profile, regardless of baseline cytogenetic risk status, in patients with high-risk relapsed multiple myeloma.
- Median PFS in the high-risk group (n=210) was 8.8 months (95 percent CI, 6.911.3) for Kyprolis patients versus 6.0 months (4.98.1) for bortezomib patients (HR: 0.646). Median PFS in the standard-risk group (n=575) was not estimable for Kyprolis (18.7NE) versus 10.2 months (9.312.2) for bortezomib (HR: 0.439).
- Grade 3 or higher adverse events for Kyprolis compared with bortezomib, in the high- and standard-risk groups, were 70.1 percent versus 63.1 percent, and 73.9 percent versus 68.3 percent, respectively.
ASH Abstract #1844: Carfilzomib and Dexamethasone versus Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma: Results of the Phase 3 Study ENDEAVOR (NCT01568866) According to Age Subgroup
In this exploratory subgroup analysis from the ENDEAVOR study according to age, treatment with Kyprolis and dexamethasone demonstrated clinically meaningful improvement in PFS compared with bortezomib and dexamethasone in all age subgroups examined, with a trend toward a greater improvement in the eldest-age subgroup (75 or older) than in the two younger-age subgroups (under 65 and 6574 years).
- Median PFS was improved with the Kyprolis regimen compared with the bortezomib regimen, within each age subgroup (under 65: NE versus 9.5 months [HR: 0.58]; 6574 years: 15.6 months versus 9.5 months [HR: 0.53]; 75 and older: 18.7 months versus 8.9 months [HR: 0.38]).
- Selected grade 3 or higher adverse events of interest that were higher in the Kyprolis arm within each age subgroup, compared with the bortezomib arm, were hypertension, dyspnea, cardiac failure and renal failure.
ASH Abstract #731: Efficacy and Safety of Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma Based on Cytogenetic Risk Status: Subgroup Analysis From the Phase 3 Study ASPIRE (NCT01080391)
This preplanned, exploratory sub-analysis assessed the efficacy and safety of Kyprolis, lenalidomide and dexamethasone (KRd) compared with lenalidomide and dexamethasone (Rd) alone, in 417 patients with relapsed multiple myeloma with high- and standard-risk cytogenetic status, and found Kyprolis had a favorable benefitrisk profile, regardless of baseline cytogenetic risk status, and improved outcomes in patients with high-risk disease.
- Median PFS in the high-risk group (n=100) was 23.1 months (95 percent CI, 12.524.2) for the Kyprolis-containing regimen versus 13.9 months (9.516.7) for lenalidomide and dexamethasone alone (HR: 0.639). Median PFS in the standard-risk group (n=317) was 29.6 months (24.1NE) for the Kyprolis-containing regimen versus 19.5 months (14.826.0) for the Rd regimen (HR: 0.657).
- Selected grade 3 or higher adverse events in patients treated with Kyprolis, in both cytogenetic risk groups, included dyspnea, hypertension, acute renal failure, cardiac failure, ischemic heart disease and peripheral neuropathy.
Amgen Webcast Investor Meeting
Amgen will host a webcast investor meeting at ASH on Monday, Dec. 7, 2015, at 7 p.m. ET. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical investigators will participate to discuss data presented at ASH and Amgen's broader oncology portfolio of products.
Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.3 It is a rare and very aggressive orphan disease that accounts for approximately one percent of all cancers.4-6 Worldwide, approximately 114,000 people are diagnosed with multiple myeloma each year and 80,000 patient deaths are reported on an annual basis.4
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) for Injection
Kyprolis® (carfilzomib) for Injection received approval from the U.S. Food and Drug Administration (FDA) in July 2015 for combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.
Kyprolis is also indicated under FDA accelerated approval in July 2012 as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
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