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Amgen Announces Data Being Presented At ASH 2019

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THOUSAND OAKS, Calif., Dec. 2, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new clinical data from its oncology in-line products and pipeline that will be presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Dec. 7-10, 2019.

The Phase 3 CANDOR study, which was accepted as a late-breaking abstract, evaluated KYPROLIS® (carfilzomib) in combination with dexamethasone and DARZALEX® (daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma. Additional data from Amgen's hematology franchise will include new results from the bispecific T cell engager (BiTE®) platform across multiple blood cancers, including multiple myeloma, acute myeloid leukemia, acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma and non-Hodgkin's lymphoma.

"The late-breaking abstract from the CANDOR study evaluating KYPROLIS with an anti-CD38 monoclonal antibody demonstrates that by combining these two powerful agents, this regimen has the potential to be practice-changing for the treatment of patients with relapsed or refractory multiple myeloma," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.

Additionally, data from study AALL1331 conducted by the Children's Oncology Group (COG) evaluating BLINCYTO® (blinatumomab) versus chemotherapy in first relapse of childhood B-lymphoblastic leukemia (B-ALL) were accepted as a late-breaking abstract. AALL1331 is sponsored by the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI), part of the National Institutes of Health, and is conducted by the NCI-funded COG. Amgen provided BLINCYTO for the study under a Collaborative Research and Development Agreement between the NCI and Amgen. BLINCYTO, which was approved in 2014, is the first and only approved BiTE molecule.

"The data being presented at ASH demonstrate our commitment to furthering the science of our in-line products, including KYPROLIS and BLINCYTO, while also advancing our pipeline of innovative BiTE molecules which could potentially provide new treatment approaches for patients across blood cancers for which there remains high unmet need," continued Reese.

A complete listing of Amgen's abstracts is available on the ASH website. Notable abstracts include:

KYPROLIS Amgen Sponsored Abstracts

  • Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma (RRMM): Primary Analysis Results from the Randomized, Open-Label, Phase 3 Study CANDOR (NCT03158688) 
    LBA-6, Tuesday, Dec. 10 from 7:30 – 9 a.m. ET in Hall D, Level 2
  • Efficacy And Safety Of Carfilzomib-Lenalidomide-Dexamethasone (KRd) In NDMM: Pooled Analysis Of 4 Single-Arm Studies
    Abstract #1891, Poster Presentation, Poster I, Saturday, Dec. 7 from 5:30 – 7:30 p.m. ET in Hall B, Level 2
  • Phase 1b Study Of Carfilzomib In Combination With Induction Chemotherapy In Children With Relapsed Or Refractory Acute Lymphoblastic Leukemia (ALL) 
    Abstract #3873, Poster Presentation, Poster III, Monday, Dec. 9 from 6 – 8 p.m. ET in Hall B, Level 2

KYPROLIS Investigator Led Abstracts  

  • Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd) Induction, Autologous Transplantation and Post-Transplant, Response-Adapted, Measurable Residual Disease (MRD)-Based Dara-KRd Consolidation in Patients with Newly Diagnosed Multiple Myeloma (NDMM)
    Abstract #860, Oral Presentation, Monday, Dec. 9 at 4:45 p.m. in Hall E2
  • Weekly Carfilzomib, Lenalidomide, Dexamethasone And Daratumumab (wKRd-D) Combination Therapy Provides Unprecedented MRD Negativity Rates In Newly Diagnosed Multiple Myeloma: A Clinical And Correlative Phase 2 Study
    Abstract #862, Oral Presentation, Monday, Dec. 9 at 5:15 p.m. in Hall E2, Level 2

BLINCYTO Amgen Sponsored Abstracts

  • Blinatumomab in Pediatric Patients With R/R B-Cell Precursor And Molecularly Resistant ALL: Updated Analysis of 110 Patients Treated in an Expanded Access Study (RIALTO)
    Abstract #1294, Poster Presentation, Poster I, Saturday, Dec. 7 from 5:30 – 7:30 p.m. ET in Hall B, Level 2
  • Open-Label, Phase 2 Study of Blinatumomab After First-Line Rituximab-Chemotherapy in Adults with Newly Diagnosed, High-Risk Diffuse Large B-Cell Lymphoma
    Abstract #4077, Poster Presentation, Poster III, Monday, Dec. 9 from 6 – 8 p.m. ET in Hall B, Level 2
  • Treatment of Adults with Relapsed/Refractory Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia with Blinatumomab in a Real-World Setting: Results from the Neuf Study
    Abstract #2627, Poster Presentation, Poster II, Sunday, Dec. 8 from 6 – 8 p.m. ET in Hall B, Level 2
  • Treatment of Adults with Minimal Residual Disease (MRD) Positive Acute Lymphoblastic Leukemia with Blinatumomab in a Real-World Setting: Results from the Neuf Study
    Abstract #2624, Poster Presentation, Poster II, Sunday, Dec. 8 from 6 – 8 p.m. ET in Hall B, Level 2

BLINCYTO Investigator Led Abstracts  

  • A Randomized Phase 3 Trial of Blinatumomab vs Chemotherapy as Post-Reinduction Therapy in High & Intermediate Risk First Relapse of B-ALL in Children & AYAs Demonstrates Superior Survival and Tolerability of Blin: A Report from Children's Oncology Group Study AALL1331 
    LBA-1, Late-Breaking Oral Presentation, Tuesday, Dec. 10 from 7:30 – 9 a.m. ET in Hall D, Level 2
  • A Phase IB Study of Blinatumomab (blina) in Patients with B Cell Acute Lymphoblastic Leukemia (ALL) and B-Cell Non-Hodgkin Lymphoma (NHL) As Post-Allogeneic Blood or Marrow Transplant (allo-BMT) Remission Maintenance
    Abstract #778, Oral Presentation, Monday, Dec. 9 at 3:30 p.m. in Chapin Theater (W320), Level 3
  • Blinatumomab/Lenalidomide in Relapsed/Refractory Non-Hodgkin's Lymphoma: A Phase I California Cancer Consortium Study of Safety, Efficacy and Immune Correlative Analysis
    Abstract #760, Oral Presentation, Monday, Dec. 9 at 3:30 p.m. in W304ABCD, Level 3
  • Updated Results of A Phase II Study of Reduced-Intensity Chemotherapy With Mini-Hyper-CVD In Combination With Inotuzumab Ozogamicin, With or Without Blinatumomab, in Older Adults with Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
    Abstract #823, Oral Presentation, Monday, Dec. 9 at 4:30 p.m. in Tangerine 1 (WF1), Level 2

XGEVA® (denosumab)

  • Progression Free Survival Analysis Of Denosumab Vs Zoledronic Acid In Intent To Transplant Multiple Myeloma Patients Based On Treatment Regimen And Baseline Characteristics
    Abstract #606, Oral Presentation, Monday, Dec. 9 at 8:15 a.m. in Sunburst Room (W340)

Oncology Pipeline

  • AMG 701 Potently Induces Anti-Multiple Myeloma (MM) Functions Of T Cells And IMiDs Further Enhance Its Efficacy To Prevent MM Relapse In Vivo
    Abstract #135, Oral Presentation, Saturday, Dec. 7 at 10 a.m. ET in Valencia A (W415A), Level 4
  • Preliminary Results From A Phase 1 First-in-Human Study Of AMG 673, A Novel Half-life Extended (HLE) Anti-CD33/CD3 BiTE® (Bispecific T-cell Engager) Molecule In Patients With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
    Abstract #833, Oral Presentation, Monday, Dec. 9 at 5:30 p.m. ET in Chapin Theater (W320), Level 3

About CANDOR
CANDOR, a randomized, open-label Phase 3 study of KYPROLIS, dexamethasone and DARZALEX (KdD) compared to KYPROLIS and dexamethasone (Kd), has evaluated 466 relapsed or refractory multiple myeloma patients who have received one to three prior therapies. Patients were treated until disease progression. The primary endpoint was PFS, and the key secondary endpoints were overall response rate, minimal residual disease and overall survival. PFS was defined as time from randomization until disease progression or death from any cause.

In the first arm, patients received KYPROLIS twice weekly at 56 mg/m2 and dexamethasone in combination with DARZALEX. In the second arm (control), patients received KYPROLIS twice weekly at 56 mg/m2 and dexamethasone.

CANDOR was initiated as part of a collaboration with Janssen, and under the terms of the agreement, Janssen co-funded the study. For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT03158688.

About the COG AALL1331 Study
The COG AALL1331 study is a risk-stratified, randomized, Phase 3 trial of blinatumomab in first relapse of pediatric B-ALL to evaluate disease-free survival (DFS) of high-risk (HR) and intermediate-risk (IR) relapsed B-ALL patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab. It also compares the DFS of low risk (LR) relapse B-ALL patients who are randomized following block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab. Key secondary endpoints include overall survival of HR, IR, and LR relapsed B-ALL patients. This is a global study that is being conducted in Australia, Canada, New Zealand and United States. Click here to read about the trial on ClinicalTrials.gov.

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 life-threatening disease that accounts for approximately one percent of all cancers.2,3 Worldwide, approximately 160,000 people are diagnosed with multiple myeloma each year, and 106,000 patient deaths are reported on an annual basis.2

About KYPROLIS® (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.4 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.4,5

Since its first approval in 2012, more than 125,000 patients worldwide have received KYPROLIS. KYPROLIS is approved in the U.S. for the following:

  • In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
  • As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy

KYPROLIS is also approved in Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New Zealand, Oman, Philippines, Qatar, Russia, Saudi Arabia, Singapore, S. Korea, Switzerland, Taiwan, Thailand, Turkey and United Arab Emirates.

Important U.S. KYPROLIS® (carfilzomib) Safety Information
Cardiac Toxicities

  • New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration.
  • Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment.
  • While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate.
  • For patients ≥ 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management.

Acute Renal Failure

  • Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency adverse events (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.

Tumor Lysis Syndrome

  • Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold until resolved.

Pulmonary Toxicity

  • Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug‐induced pulmonary toxicity, discontinue KYPROLIS.

Pulmonary Hypertension

  • Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.

Dyspnea

  • Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment.

Hypertension

  • Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment.

Venous Thrombosis

  • Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Thromboprophylaxis is recommended for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient's underlying risks.
  • Patients using hormonal contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment.

Infusion Reactions

  • Infusion reactions, including life‐threatening reactions, have occurred. Symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms and seek immediate medical attention if they occur.

Hemorrhage

  • Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.

Thrombocytopenia

  • KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate.

Hepatic Toxicity and Hepatic Failure

  • Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate.

Thrombotic Microangiopathy

  • Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known.

Posterior Reversible Encephalopathy Syndrome (PRES)

  • Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known.

Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients

  • In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma.

Embryo-fetal Toxicity

  • KYPROLIS can cause fetal harm when administered to a pregnant woman.
  • Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS and for 3 months following the final dose. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.

ADVERSE REACTIONS

  • The most common adverse reactions in the combination therapy trials: anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper respiratory tract infection, hypokalemia.
  • The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytope
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