Amgen Biotech Experience Student Guide Answers
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THOUSAND OAKS, Calif., Nov. 1, 2018 /PRNewswire/ - Amgen (NASDAQ:AMGN) today announced that new clinical data will be presented at the 60 th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, Dec. Data across an array of malignancies will be featured in 45 abstracts, including nine oral presentations, from the Company's broad portfolio and early-stage pipeline. The breadth of data to be presented at ASH this year represent Amgen's continued search for answers to complex scientific questions, leveraging its long-standing expertise in blood cancers to develop early immuno-oncology pipeline candidates and innovative biologics in areas of significant unmet need. Notable data include two oral presentations on first-in-human studies evaluating two early-stage bi-specific T cell engager (BiTE ®) molecules – AMG 420 and AMG 330.
BiTE ® molecules are designed to harness the immune system and can be modified in an effort to enable cytotoxic T cells in the body to recognize cancer cells and destroy them. Additional data from Amgen's hematology franchise will also be featured, including long-term overall survival (OS) data for BLINCYTO ® (blinatumomab) in patients who had achieved complete minimal residual disease (MRD) response and for once-weekly dosing of KYPROLIS ® (carfilzomib) in combination with dexamethasone.
'For nearly four decades, Amgen has been at the forefront of cutting-edge science that has helped change treatment paradigms for patients with difficult-to-treat blood cancers. Today, we are on the cusp of a new wave of advances that harness the body's own immune system to transform cancer care,' said David M.
Reese, M.D., executive vice president of Research and Development at Amgen. 'We're excited to present the first data from our early oncology pipeline, including two investigational BiTE ® candidates, which demonstrate our commitment to tackling the toughest scientific questions for cancer patients.'
A complete listing of abstracts can be found on the ASH website. Notable abstracts of interest include: Expanding Investigation of BiTE ® Across Hematologic Malignancies. A Phase 1 First-in-Human Study of AMG 330, an Anti-CD33 Bispecific T-Cell Engager (BiTE ®) Antibody Construct, in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Abstract #25, Oral Presentation, Saturday, Dec. 1 at 7:30 a.m. PT in Manchester Grand Hyatt San Diego, Seaport Ballroom F. Open-Label, Phase 2 Study of Blinatumomab as Second Salvage Therapy in Adults with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma Abstract #400, Oral Presentation, Sunday, Dec. 2 at 12:45 p.m.
Amgen Biotech Experience Student Guide Answers
PT in Marriott Marquis San Diego Marina, Pacific Ballroom 20. Treatment with AMG 420, an anti-B-Cell Maturation Antigen (BCMA) Bispecific T-cell Engager (BiTE ®) Antibody Construct, Induces Minimal Residual Disease (MRD) Negative Complete Responses in Relapsed and/or Refractory (R/R) Multiple Myeloma (MM) Patients: Results of a First-in-Human (FIH) Phase I Dose Escalation Study Abstract #1010, Oral Presentation, Monday, Dec. 3 at 6:30 p.m.
PT in San Diego Convention Center, Ballroom 20D. Blinatumomab for Minimal Residual Disease (MRD) in Adults with B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL): Median Overall Survival (OS) Is Not Reached in Complete MRD Responders at a Median Follow-up of 53.1 Months Abstract #554, Oral Presentation, Monday, Dec. 3 at 7:15 a.m. PT in San Diego Convention Center, Ballroom 20A Evaluating Outcomes in Multiple Myeloma. Carfilzomib in Relapsed or Refractory Multiple Myeloma Patients with Early or Late Relapse Following Prior Therapy: An Analysis of Overall Survival in Subgroups from the Randomized Phase 3 ASPIRE and ENDEAVOR Trials Abstract #1964, Poster Presentation, Saturday Dec.
1 at 6:15 p.m. PT in San Diego Convention Center, Hall GH. Efficacy and Safety of Once-weekly vs Twice-weekly Carfilzomib Plus Dexamethasone: Subgroup Analysis of the Phase 3 A.R.R.O.W. Study (NCT02412878) by Prior Lines Abstract #3244, Poster Presentation, Sunday, Dec. 2 from 6 p.m. PT in San Diego Convention Center, Hall GH.
Once Weekly Versus Twice Weekly Carfilzomib Dosing in Patients With Relapsed and Refractory Multiple Myeloma (A.R.R.O.W.): Efficacy and Safety Analyzed by Age Group Abstract #3277, Poster Presentation, Sunday, Dec. 2 from 6 p.m. PT in San Diego Convention Center, Hall GH. Carfilzomib-Lenalidomide-Dexamethasone Versus Bortezomib-Lenalidomide-Dexamethasone in Real-World Patients With Newly Diagnosed Multiple Myeloma: Results from a Prospective, Longitudinal, Observational Study (CoMMpass) Abstract #799, Oral Presentation, Monday, Dec.
3 at 2:45 p.m. PT in San Diego Convention Center, Room 6F.
Could Patients with Multiple Myeloma (MM) Derive Additional Benefit From Their Treatments? Real World Evidence for Carfilzomib Dosing Intensity on Survival and Treatment Progression Abstract #836, Oral Presentation, Monday, Dec. PT in San Diego Convention Center, Room 25B.
A Phase 1b Study of Oprozomib with Dexamethasone or Pomalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma Abstract #803, Oral Presentation, Monday, Dec. 3 at 3:45 p.m.
PT in San Diego Convention Center, Room 6F Amgen Webcast Investor Meeting Amgen will host a webcast investor meeting at ASH 2018 on Monday, Dec. Reese, 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 at the investor meeting to discuss Amgen's oncology program and data presented at ASH 2018.
Live audio of the conference call will be broadcast over the internet simultaneously 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 at certain investor and medical conferences, can be accessed on Amgen's website, 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 BiTE ® Technology Bispecific T cell engager (BiTE ®) antibody construct is an innovative technology that can be engineered to target any tumor antigen expressed by any type of cancer. The protein molecules are designed to kill malignant cells using the patient's own immune system by bridging T cells to tumor cells. BiTE ® antibody construct helps connect the T cells to the targeted cell, with the intent of causing T cells to inject toxins which trigger cancer cell death (apoptosis).
Amgen is developing BiTE ® antibody constructs to uniquely (or specifically) target numerous hematologic malignancies and solid tumors. About BLINCYTO ® (blinatumomab) BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE ®) immunotherapy that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of effector T cells.
BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration (FDA) in 2014, and now carries full approval in the U.S. For the treatment of relapsed or refractory B-cell precursor ALL in adults and children. In the U.S., BLINCYTO is also approved under accelerated approval for the treatment of adults and children with B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent. BLINCYTO is now approved in 57 countries, including all member countries in the European Union and the European Economic Area, Canada, Japan, and Australia. BLINCYTO ® U.S.
Product Safety Information Indication and Important Safety Information, including Boxed WARNINGS, for BLINCYTO ® (blinatumomab) for injection, for intravenous use INDICATION BLINCYTO is indicated for the treatment of adults and children with:. B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Relapsed or refractory Bcell precursor acute lymphoblastic leukemia (ALL) 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): CRS, which may be life-threatening or fatal, occurred in patients receiving BLINCYTO ®. The median time to onset of CRS is 2 days after the start of infusion.
Closely monitor patients for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO overlap with those of infusion reactions, capillary leak syndrome (CLS), and hemophagocytic histiocytosis/macrophage activation syndrome (MAS). In clinical trials of BLINCYTO, CRS was reported in 15% of patients with relapsed or refractory ALL and in 7% of patients with MRD-positive ALL. Toyota starlet wiki. Interrupt or discontinue BLINCYTO ® as outlined in the PI.
Neurological Toxicities: Approximately 65% of patients receiving BLINCYTO ® in clinical trials experienced neurological toxicities. The median time to the first event was within the first 2 weeks of BLINCYTO ® treatment and the majority of events resolved. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Severe, life‐threatening, or fatal neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Manifestations of neurological toxicity included cranial nerve disorders.
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Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO ® as outlined in the PI. Infections: Approximately 25% of patients receiving BLINCYTO ® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site 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. Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO ® treatment.
Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO ® as needed to manage these events. Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO ® infusion and interrupt BLINCYTO ® if prolonged neutropenia occurs. Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO ® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO ® is being administered. Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO ® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO ®, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients.
Monitor ALT, AST, gamma-glutamyl transferase (GGT), and TBILI prior to the start of and during BLINCYTO ® treatment. BLINCYTO ® treatment should be interrupted if transaminases rise to 5 times the upper limit of normal (ULN) or if TBILI rises to 3 times ULN. Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO ® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO ® and dexamethasone as needed.
Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO ®, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy. Preparation and administration errors have occurred with BLINCYTO ® treatment.
Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose). Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO ® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO ®. Risk of Serious Adverse Reactions in Pediatric Patients due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions including 'gasping syndrome,' which is characterized by central nervous system depression, metabolic acidosis, and gasping respirations, can occur in neonates and infants treated with benzyl alcohol-preserved drugs including BLINCYTO ® (with preservative). When prescribing BLINCYTO ® (with preservative) for pediatric patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO ® (with preservative) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Due to the addition of bacteriostatic saline, 7-day bags of BLINCYTO ® solution for infusion with preservative contain benzyl alcohol and are not recommended for use in any patients weighing.