Presentations include data from the pivotal trial of Kyprolis® (carfilzomib) for Injection in relapsed multiple myeloma, and blinatumomab studies in adult acute lymphoblastic leukemia (ALL) and relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Additional data will be presented evaluating oprozomib in multiple myeloma and Waldenström macroglobulinemia, AMG 330 in acute myeloid leukemia (AML), and an analysis of Onyx's patient support and services program
"The presentations at ASH demonstrate our commitment to taking on the toughest challenges in hematology and oncology by developing innovative treatments for patients with difficult-to-treat blood cancers," said
A full list of
Notable abstracts of interest:
Kyprolis® (carfilzomib) for Injection
Results will be presented from ASPIRE, a randomized, open-label, multicenter Phase 3 study comparing carfilzomib, lenalidomide, and dexamethasone to lenalidomide, and dexamethasone in patients with relapsed multiple myeloma.
BiTE® Antibody Constructs (blinatumomab and AMG 330)
Data on two investigational bispecific T cell engager (BiTE®) antibody constructs, blinatumomab and AMG 330, will be presented at ASH. BiTE® antibody constructs represent an innovative immunotherapy approach that helps the body's immune system target cancer cells.
Key data on blinatumomab include two analyses from Study '211, a pivotal Phase 2 trial in patients with ALL; results from BLAST, a confirmatory single-arm, Phase 2 study in patients with minimal residual disease positive ALL; and long-term follow-up data from Study '206, an exploratory Phase 2 study in patients with relapsed/refractory B-precursor ALL.
Key data on AMG 330 include three preclinical studies evaluating its potential as a therapeutic agent in AML.
Results will be presented from two Phase 1b/2 studies, including one trial evaluating oprozomib in adult patients with hematologic malignancies who have relapsed after receiving ≥1 line of therapy and another trial in patients with a form of non-Hodgkin's lymphoma. Oprozomib was recently granted orphan drug designation for the treatment of Waldenström macroglobulinemia and multiple myeloma.
About Kyprolis® (carfilzomib) for Injection
Kyprolis is marketed in the U.S. by
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent Kyprolis. There were 37 deaths in the Phase 2 studies, or 7% of patients. The most common causes of death, other than disease progression, were cardiac (5 patients), end-organ failure (4 patients), and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia; pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New 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 cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with Kyprolis and was Grade 3 or greater in less than 1% of patients. Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 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, vomiting, weakness, shortness of breath, hypotension, syncope, chest 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 severity of reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis administration in < 1% of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with Kyprolis in < 1% of patients.
Cases of hepatic failure, including fatal cases, have been reported (< 1%). Kyprolis can cause elevations of serum transaminases and bilirubin.
There are no adequate and well-controlled studies in 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% or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Serious adverse reactions were reported in 45% of patients.
Full prescribing information is available at http://www.kyprolis.com.
About BiTE® Technology
Bispecific T cell engager (BiTE®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body's immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.
Blinatumomab is an investigational BiTE® antibody construct designed to direct the body's cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. Blinatumomab, the first of the investigational BiTE® antibody constructs, has received orphan drug designation from the
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.
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