Amgen announces presentation of new clinical data showcasing early oncology pipeline at ASH 2018

First-in-Human Data Evaluating AMG 420 in Multiple Myeloma and AMG 330 in Acute Myeloid Leukemia Underscore Potential of BiTE® Immunotherapy Platform Across Hematologic Malignancies

BLINCYTO® (Blinatumomab) Long-Term Data Demonstrate Benefits of Achieving Complete MRD Response in Adult Patients With Acute Lymphoblastic Leukemia and Reinforce BiTE® Proof-of-Concept

Data From Multiple Myeloma Research Foundation CoMMpass Trial  of KYPROLIS® (Carfilzomib) in Newly Diagnosed Multiple Myeloma Patients to be Presented at ASH

Amgen today announced that new clinical data will be presented at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, Dec. 1-4, 2018. 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. 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 from6p.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 6:00 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. 3 at 3 p.m. 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. 4 at 8 p.m. PT. David M. 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, 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.

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