Data From Largest Oncology Pipeline in Company's History
First-in-Human Data Evaluating Investigational AMG 510, the First KRASG12C Inhibitor to Reach Clinical Stage, in Solid Tumors
Potential Versatility of BiTE® Immuno-oncology Platform Reinforced With Phase 1 Asset Updates
THOUSAND OAKS, Calif., May 15, 2019 /PRNewswire/ -- Amgen (AMGN) today announced that data from its oncology pipeline will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, May 31-June 4, 2019. Seven investigational assets will be featured across a range of hematologic malignancies and solid tumors.
"Biology and human genetics have been the foundation of Amgen's innovation for the last four decades," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Based on the fundamentals of our science and the speed at which we are moving, I believe Amgen will have a profound effect on how certain cancers are treated in the future. We are committed to bringing novel cancer therapies more quickly than ever before to the patients who need them."
Notable data from the Company's oncology pipeline include first-in-human data for investigational AMG 510, the first KRASG12C inhibitor to reach the clinical stage in patients with locally-advanced or metastatic KRASG12C mutant solid tumors. Additional early-stage pipeline data will showcase Amgen's bispecific T cell engager (BiTE®) platform across hematologic malignancies and solid tumors, including for the first time, in prostate cancer. BiTE molecules are designed to engage patients' T cells to tumor-specific antigens, activating the cytotoxic potential of T cells with the goal of eliminating detectable cancer. Updated results will also be presented from a Phase 1 dose escalation study evaluating investigational AMG 420, a B-cell maturation antigen (BCMA) targeting BiTE molecule, in patients with relapsed or refractory multiple myeloma.
A complete listing of Amgen's abstracts is available on the ASCO website. Notable abstracts include:
Clinical Data Abstracts
- Phase 1 Study of Pasotuxizumab (BAY 2010112), a PSMA-Targeting Bispecific T cell Engager (BiTE) Immunotherapy for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Abstract #5034, Poster Presentation, Saturday, June 1 from 1:15-4:15 p.m. CT in McCormick Place, Hall A
- Evaluation of AMG 420, an anti-BCMA Bispecific T-cell Engager (BiTE) Immunotherapy, in R/R Multiple Myeloma (MM) Patients: Updated Results of a First-in-Human (FIH) Phase 1 Dose Escalation Study
Abstract #8007, Oral Presentation, Sunday, June 2 from 11:57 a.m.–12:09 p.m. CT in McCormick Place, Room E451
- Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Efficacy of AMG 510, a Novel Small Molecule KRASG12C Inhibitor, in Advanced Solid Tumors
Abstract #3003, Oral Presentation, Monday, June 3 from 9–9:12 a.m. CT in McCormick Place, Room S406
- Phase 1 Study of AMG 757, a Half-Life Extended Bi-Specific T Cell Engager (BiTE) Antibody Construct Targeting DLL3, in Patients with Small Cell Lung Cancer (SCLC)
Abstract #TPS8577, Poster Presentation, Sunday, June 2 from 8–11 a.m. CT in McCormick Place, Hall A
- Phase 1 Study of AMG 119, a Chimeric Antigen Receptor (CAR) T Cell Therapy Targeting DLL3, in Patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Abstract #TPS8576, Poster Presentation, Sunday, June 2 from 8–11 a.m. CT in McCormick Place, Hall A
- Novel anti-EGFRvIII Bispecific T Cell Engager (BiTE) Antibody Construct in Glioblastoma (GBM): Trial in Progress of AMG 596 in Patients with Recurrent or Newly Diagnosed Disease
Abstract #TPS2071, Poster Presentation, Sunday, June 2 from 8–11 a.m. CT in McCormick Place, Hall A
Amgen Webcast Investor Meeting
Amgen will host a webcast investor meeting at ASCO 2019 on Monday, June 3 at 6:30 p.m. CT. 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 ASCO 2019.
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.
The subject of more than three decades of research, RAS proteins make up the most frequently mutated gene family in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRASG12C accounts for approximately 12 percent of all KRAS mutations across tumor types.3 Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.
About BiTE® Technology
Bispecific T cell engager (BiTE®) technology is a targeted immuno-oncology platform that is designed to engage patients' own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform leads to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.
About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patients' life – not just their cancer journey – so they can take control of their lives.
For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the company's history, moving with great speed to advance those innovations for the patients who need them.
At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.
For more information, follow us on www.twitter.com/amgenoncology.
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.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (Media)
Trish Hawkins, 805-447-5631 (Media)
Arvind Sood, 805-447-1060 (Investors)
- Cox A, et al. Drugging the undruggable RAS: Mission Possible?. Nature Reviews Drug Discovery. 2014;13(11):828-851.
- Fernandez-Medarde A, Santos E. Ras in Cancer and Developmental Diseases. Genes Cancer. 2011;2(3):344-358.
- Hobbs G, Wittinghofer A, Der C. Selective Targeting of the KRAS G12C Mutant: Kicking KRAS When It's Down. Cancer Cell. 2016;29(3):251-253.
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