Key Data For Amgen Medicines In Relapsed Multiple Myeloma And Acute Lymphoblastic Leukemia To Be Presented At American Society of Hematology 2015
THOUSAND OAKS, Calif., Nov. 5, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that a number of important abstracts from the Company's oncology portfolio, including Kyprolis® (carfilzomib) for Injection, BLINCYTO® (blinatumomab), Nplate® (romiplostim) and Neulasta® (pegfilgrastim), are scheduled for presentation at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition, Dec. 58, 2015, in Orlando, Fla.
"We look forward to sharing new data that further demonstrate our commitment to studying innovative cancer therapies across the treatment continuum for patients with difficult-to-treat conditions," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "In particular, we are encouraged by the breadth of data continuing to emerge from the Kyprolis clinical trial program, which further support the use of Kyprolis as an increasingly critical component in the treatment of patients with relapsed multiple myeloma."
Highlighted data in oral presentations and posters from the Kyprolis clinical trial program are based on subgroup analyses of the Phase 3 ENDEAVOR and ASPIRE studies evaluating Kyprolis-based regimens in more difficult-to-treat patients, including those at least 70 years of age, and those with a high-risk cytogenetic profile. The four oral presentations highlighting Kyprolis data are as follows:
- Efficacy and Safety of Carfilzomib and Dexamethasone vs. Bortezomib and Dexamethasone with Relapsed Multiple Myeloma Based on Cytogenetic Risk Status: Subgroup Analysis from the Phase 3 Study ENDEAVOR (NCT01568866)
Abstract #30, Oral Presentation, Saturday, Dec. 5, at 8:45 a.m. ET in the Orange County Convention Center, Tangerine 2 (WF2) - Weekly Carfilzomib with Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma: Updated Results from the Phase 1/2 Study CHAMPION-1 (NCT01677858)
Abstract #373, Oral Presentation, Sunday, Dec. 6, at 4:30 p.m. ET in the Orange County Convention Center, Hall E1 - Impact of Prior Treatment on Patients with Relapsed Multiple Myeloma Treated with Carfilzomib and Dexamethasone vs. Bortezomib and Dexamethasone in a Subgroup Analysis of the Phase 3 ENDEAVOR Study (NCT01568866)
Abstract #729, Oral Presentation, Monday, Dec. 7, at 3:15 p.m. ET in the Orange County Convention Center, Tangerine 2 (WF2) - Efficacy and Safety of Carfilzomib, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Patients with Relapsed Multiple Myeloma Based on Cytogenetic Risk Status: Subgroup Analysis From the Phase 3 Study ASPIRE (NCT01080391)
Abstract #731, Oral Presentation, Monday, Dec. 7, at 3:45 p.m. ET in the Orange County Convention Center, Tangerine 2 (WF2)
The following three oral presentations on new data from our comprehensive acute lymphoblastic leukemia (ALL) development program for BLINCYTO will be presented:
- Complete Molecular and Hematologic Response in Adult Patients with Relapsed/Refractory (R/R) Philadelphia Chromosome-positive B-precursor Acute Lymphoblastic Leukemia (ALL) following Treatment with Blinatumomab: Results from a Phase 2 Single-arm, Multicenter Study (ALCANTARA)
Abstract #679, Oral Presentation, Monday, Dec. 7, at 2:45 p.m. ET in the Orange County Convention Center, W224CDGH - Long-Term Outcomes after Blinatumomab Treatment: Follow-up of a Phase 2 Study in Patients (Pts) with Minimal Residual Disease (MRD) Positive B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Abstract #680, Oral Presentation, Monday, Dec. 7, at 3 p.m. ET in the Orange County Convention Center, W224CDGH - Treatment with anti-CD19 BiTE® Blinatumomab in Adult Patients with Relapsed/Refractory B precursor Acute Lymphoblastic Leukemia (r/r ALL) Post-Allogeneic Hematopoietic Stem Cell Transplantation
Abstract #861, Oral Presentation, Monday, Dec. 7, at 5 p.m. ET in the Orange County Convention Center, Tangerine 2 (WF2)
Key data from the Nplate clinical trial program will also be presented with new insights regarding use of Nplate in treating pediatric and adult immune thrombocytopenia patients, including:
- A Phase 3, Randomized, Double-Blind, PBO-Controlled Study to Determine the Safety and Efficacy of Romiplostim in Children with Immune Thrombocytopenia (ITP)
Abstract #7, Oral Presentation, Saturday, Dec. 5, at 7:30 a.m. ET in Orange County Convention Center, W315 - Effect of Romiplostim on Health Related Quality of Life in Children with Immune Thrombocytopenia and Associated Burden in Their Parents: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Abstract #37, Oral Presentation, Saturday, Dec.5, at 7:30 a.m. ET in Orange County Convention Center, W230 - Rate of Bleeding-Rated Episodes (BREs) in Elderly Patients with Primary Immune Thrombocytopenia (ITP): A Population-Based Retrospective Cohort Study Using Medicare 20% Sample Data
Abstract #38, Oral Presentation, Saturday, Dec. 5, at 7:45 a.m. ET in Orange County Convention Center, W230 - Safety and Efficacy of Long-Term Open-Label Dosing of Subcutaneous (SC) Romiplostim in Pediatric Patients With Immune Thrombocytopenia (ITP)
Abstract #3467, Poster, Monday, Dec. 7, from 6 p.m. ET in Orange County Convention Center, Hall A
Key data will be presented highlighting the risk of febrile neutropenia (FN) and the burden of oncology clinic visits for treatment with granulocyte-colony stimulating factor (G-CSF) therapy:
- Annual Patient and Caregiver Burden of Oncology Clinic Visits for Granulocyte-Colony Stimulating Factor (G-CSF) Therapy in the United States (US)
Abstract #2066, Poster, Saturday,Dec. 5, at 5:30 p.m. ET in Orange County Convention Center, Hall A - Risk of Febrile Neutropenia (FN) in Select Myelosuppressive Chemotherapy Regimens
Abstract #3257, Poster, Sunday, Dec. 6, at 6 p.m. ET in Orange County Convention Center, Hall A
Four additional abstracts have been accepted for presentation highlighting investigational compounds from the Amgen pipeline, including:
- Oprozomib, Pomalidomide, and Dexamethasone (OPomd) in Patients (Pts) With Relapsed and/or Refractory Multiple Myeloma (RRMM): Initial Results of a Phase 1b Study
Abstract #378, Oral Presentation, Sunday, Dec. 6, at 5:45 p.m. ET in the Orange County Convention Center, Hall E1 - Expression of Novel Immune Checkpoint Molecules PVR and PVRL2 Confers a Negative Prognosis to Patients with Acute Myeloid Leukemia and Their Blockade Augments T-Cell Mediated Lysis of AML Cells Alone or in Combination with the BiTE® Antibody Construct AMG 330
Abstract #789, Oral Presentation, Monday, Dec. 7, at 5 p.m. ET in the Orange County Convention Center, W307 - Identifying Immune Resistant Mechanisms to CD33/CD3 BiTE® Antibody Construct (AMG 330) Mediated Cytotoxicity
Abstract #3677, Poster, Monday, Dec. 7, from 68 p.m. ET in the Orange County Convention Center, Hall A
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 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. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for Kyprolis in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy in September 2015.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan. Kyprolis is also approved for use in Argentina, Israel, Kuwait, Mexico and Thailand. For more information about Kyprolis, visit www.kyprolis.com.
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
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. Death due to cardiac arrest has occurred within a day of Kyprolis administration.
Withhold Kyprolis for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart Kyprolis based on a benefit/risk assessment.
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 in patients with baseline cardiac failure or who are at risk for cardiac failure.
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, and conduction abnormalities may be at greater risk for cardiac complications.
Acute Renal Failure
Cases of acute renal failure and renal insufficiency adverse events (renal impairment, acute renal failure, renal failure) have occurred in patients receiving Kyprolis. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy. This risk was greater in patients with a baseline reduced estimated creatinine clearance. 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 in patients receiving Kyprolis. Patients with multiple myeloma and 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. Withhold Kyprolis until TLS is 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 in patients receiving Kyprolis. Some events have been fatal. In the event of drug-induced pulmonary toxicity, discontinue Kyprolis.
Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) was reported in patients treated with Kyprolis. 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 Kyprolis 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 Kyprolis based on a benefit/risk assessment.
Hypertension
Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. Some of these events have been fatal. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold Kyprolis and evaluate. Consider whether to restart Kyprolis based on a benefit/risk assessment.
Venous Thrombosis
Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed with Kyprolis. Thromboprophylaxis is recommended and should be based on an assessment of the patient's underlying risks, treatment regimen, and clinical status.
Infusion Reactions
Infusion reactions, including life-threatening reactions, have occurred in patients receiving Kyprolis. 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 of Kyprolis. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms of an infusion reaction and to contact a physician immediately if they occur.
Thrombocytopenia
Kyprolis causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Thrombocytopenia was reported in patients receiving Kyprolis. Monitor platelet counts frequently during treatment with Kyprolis. Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
Cases of hepatic failure, including fatal cases, have been reported during treatment with Kyprolis. Kyprolis can cause increased serum transaminases. Monitor liver enzymes regularly. Reduce or withhold dose as appropriate.
Thrombotic Thrombocytopenic Purpura /Hemolytic Uremic Syndrome (TTP/HUS)
Cases of TTP/HUS including fatal outcome have occurred in patients receiving Kyprolis. Monitor for signs and symptoms of TTP/HUS. Discontinue Kyprolis if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, Kyprolis may be restarted. The safety of reinitiating Kyprolis therapy in patients previously experiencing TTP/HUS is not known.
Posterior Reversible Encephalopathy Syndrome (PRES)
Cases of PRES have occurred in patients receiving Kyprolis. PRES was formerly known as Reversible Posterior Leukoencephalopathy Syndrome. Consider a neuro-radiological imaging (MRI) for onset of visual or neurological symptoms. Discontinue Kyprolis if PRES is suspected and evaluate. The safety of reinitiating Kyprolis therapy in patients previously experiencing PRES is not known.
Embryo-fetal Toxicity
Kyprolis can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals.
Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis and the potential hazard to the fetus if Kyprolis is used during pregnancy.
ADVERSE REACTIONS
The most common adverse events occurring in at least 20% of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, decreased platelets, dyspnea, diarrhea, decreased lymphocyte, headache, decreased hemoglobin, cough, edema peripheral.
The most common adverse events occurring in at least 20% of patients treated with Kyprolis in the combination therapy trial: decreased lymphocytes, decreased absolute neutrophil count, decreased phosphorus, anemia, neutropenia, decreased total white blood cell count, decreased platelets, diarrhea, fatigue, thrombocytopenia, pyrexia, muscle spasm, cough, upper respiratory tract infection, decreased hemoglobin, hypokalemia.
Full prescribing information is available at www.kyprolis.com.
About BLINCYTO® (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell engager that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.
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 benign and malignant cells expressing a particular antigen. 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 cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.
BLINCYTO was granted breakthrough therapy status and priority review designations by the FDA, and is now approved in the U.S. for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for BLINCYTO for the treatment of adults with Ph- relapsed or refractory B-precursor ALL in September 2015.
Important U.S. Product Information Regarding BLINCYTO (blinatumomab)
BLINCYTO is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
- Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO® as recommended.
- Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO® as recommended.
Contraindications
BLINCYTO is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Warnings and Precautions
- Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS occurred in patients receiving BLINCYTO. Infusion reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients for signs and symptoms of serious events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Interrupt or discontinue BLINCYTO as outlined in the Prescribing Information (PI).
- Neurological Toxicities: Approximately 50% of patients receiving BLINCYTO® in clinical trials experienced neurological toxicities. Severe, life-threatening, or fatal neurological toxicities occurred in approximately 15% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. The median time to onset of any neurological toxicity was 7 days. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO as outlined in the PI.
- Infections: Approximately 25% of patients receiving BLINCYTO® experienced serious infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO as needed.
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