Benzinga | Dec 6, 2021 04:03PM EST

Amgen To Present At ASH 2021 Dec. 11-14

Amgen (NASDAQ:AMGN) today announced new data from its hematology pipeline and marketed portfolio to be presented at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition in Atlanta, Georgia, and virtually, from Dec. 11-14, 2021.

"The data being presented at ASH demonstrates Amgen's commitment to reaching more patients with our innovative hematology medicines and improving the patient experience by exploring more convenient administrations for people living with blood cancers," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "By accelerating the development and delivery of transformative medicines in difficult to treat and vulnerable patient populations, including children and pregnant women, we continue to focus on the relentless pursuit of breakthroughs for blood cancer patients and their families."

Amgen will present data on its bispecific T-cell engager (BiTE(r)) platform, including BLINCYTO(r) (blinatumomab), as well as KYPROLIS(r) (carfilzomib) and Nplate(r) (romiplostim). Updated data from the Phase 3 '215 trial in children with high-risk first relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) showed BLINCYTO improved event-free survival (EFS) and overall survival (OS) versus chemotherapy before allogeneic hematopoietic stem cell transplant (alloHSCT). The first presentation of safety and efficacy data with BLINCYTO administered subcutaneously in adults with relapsed or refractory B-ALL also demonstrated encouraging results.

Additionally, results from the Phase 1b study investigating KYPROLIS in combination with vincristine, dexamethasone, PEG-asparaginase, daunorubicin (VXLD) induction therapy in children with relapsed or refractory ALL showing promising efficacy in highly advanced relapsed/refractory pediatric ALL will be presented in a poster discussion session. Analyses from the Pregnancy Surveillance Program (PSP) evaluating pregnancy and fetal outcomes of women exposed to Nplate highlighting no substantial safety concerns identified for mothers, fetuses and infants due to Nplate use during pregnancy will also be shared as an oral presentation on Monday, Dec. 13, 2021.

Abstracts are available on the ASH website.

Key Abstracts and Presentation Times:

Disease State Amgen Sponsored Abstracts

* Real World Assessment of Treatment Patterns and Outcomes Among Multiple Myeloma Patients Across Different Risk Stratification Criteria in the United States: A Retrospective Cohort Study Abstract #1640, Poster Presentation, Saturday, Dec. 11 from 5:30 -- 7:30 p.m. ET

* Outcomes of Triple-Class (Proteasome Inhibitor, Immunomodulator, CD38 Monoclonal Antibody) Exposed Relapsed or Refractory Multiple Myeloma (RRMM) in United States (US) Real-World Practice Abstract #3042, Poster Presentation, Sunday, Dec. 12 from 6 -- 8 p.m. ET

* A Temporal and Multinational Assessment of Acute Myeloid Leukemia (AML) Cancer Incidence, Survival and Disease Burden Abstract #4124, Poster Presentation, Monday, Dec. 13 from 6 -- 8 p.m. ET

BLINCYTO Amgen Sponsored Abstracts

* Superior Overall Survival With Blinatumomab Versus Chemotherapy in Children With High-Risk First Relapse of B-cell Precursor Acute Lymphoblastic Leukemia: A Randomized, Controlled Phase 3 Trial Abstract #1231, Poster Presentation, Saturday, Dec. 11 from 5:30 -- 7:30 p.m. ET

* Safety and Efficacy of Subcutaneous (SC) Blinatumomab for the Treatment of Adults with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) Abstract #2303, Poster Presentation, Sunday, Dec. 12 from 6 -- 8 p.m. ET

* A Phase 1b Study of Blinatumomab Regimen Including Subcutaneous Administration in Relapsed / Refractory (R/R) Indolent Non-Hodgkin's Lymphoma (NHL) Abstract #2436, Poster Presentation, Sunday, Dec. 12 from 6 -- 8 p.m. ET

* Heterogeneity of Minimal/Measurable Residual Disease (MRD) Practices in Adult B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) in the United States Online Publication

BLINCYTOInvestigator Sponsored Studies (ISS)

* Updated Results From a Phase II Study of Hyper-CVAD with Sequential Blinatumomab in Adults with Newly Diagnosed Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia Abstract #1233, Poster Presentation, Saturday, Dec. 11 from 5:30 -- 7:30 p.m. ET

* A Randomized Phase 3 Trial of Blinatumomab vs. Chemotherapy as Post-Reinduction Therapy in Low Risk (LR) First Relapse of B-Acute Lymphoblastic Leukemia (B-ALL) in Children and Adolescents/Young Adults (AYAs): A Report from Children's Oncology Group Study Abstract #363, Oral Presentation, Sunday, Dec. 12 at 10 a.m. ET

KYPROLIS Amgen Sponsored Abstracts

* Phase 1b Study of Carfilzomib in Combination with Induction Chemotherapy in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) Abstract #1235, Poster Presentation, Saturday, Dec. 11 from 5:30 -- 7:30 p.m. ET

* Phase 2 Study of Carfilzomib in Combination with Induction Chemotherapy in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) Abstract #4403, Online Publication

KYPROLISInvestigator Sponsored Studies (ISS)

* Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd), Autologous Transplantation and MRD Response-Adapted Consolidation and Treatment Cessation. Final Primary Endpoint Analysis of the MASTER Trial Abstract #481, Oral Presentation, Sunday, Dec. 12 at 12 p.m. ET

* Biologic Basis of the Impact of Autologous Hematopoietic Cell Transplantation in Multiple Myeloma Treated with Quadruplet Therapy Abstract #483, Oral Presentation, Sunday, Dec. 12 at 12:30 p.m. ET

Nplate Clinical Data Abstracts

* Surveillance Program of Romiplostim Use Connected to Pregnancy Abstract #585, Oral Presentation, Monday, Dec. 13 from 10:30 a.m. -- 12 p.m. ET

* Romiplostim for the Treatment of Adult Patients with Newly Diagnosed or Persistent Immune Thrombocytopenia: Subgroup Analysis from a Phase 2 Study Abstract #3157, Poster Presentation, Monday, Dec. 13 from 6 -- 8 p.m. ET

* Thrombocytopenia Among Patients with Hematologic Malignancies and Solid Tumors: Risk and Prognosis Abstract #3156, Poster Presentation, Monday, Dec. 13 from 6 -- 8 p.m. ET

* Investigating the Potential Impact of Dosing Tolerance to Facilitate Use of Nplate Self-Administration in Adult Patients with ITP Online Publication

* Assessing Romiplostim Dose and Platelet Response-Guided Titration to Support Use of Romiplostim in ITP Patients Less Than 12 months From Diagnosis Online Publication

NplateInvestigator Sponsored Studies (ISS)

* Immunomodulation with Romiplostim in Young Adult Primary Immune Thrombocytopenia (ITP) As Second-Line Strategy (iROM-study) Abstract #3149, Poster Presentation, Monday, Dec. 13 from 6 -- 8 p.m. ET