Amgen To Present First Clinical Data For BCMA-Targeted Half-Life Extended BiTE® Therapy AMG 701 At ASH 2020

THOUSAND OAKS, Calif., Dec. 5, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the first presentation of clinical safety and efficacy data from the Phase 1 study of AMG 701 in heavily pre-treated patients with relapsed/refractory multiple myeloma (R/R MM). AMG 701 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE^®) immuno-oncology therapy targeting B-cell maturation antigen (BCMA). The data will be presented during a live oral presentation on Dec. 5 at the virtual 62^nd American Society of Hematology (ASH) Annual Meeting & Exposition.

"The emerging data from the BiTE platform in hematological malignancies are encouraging. Previously, Amgen provided important evidence for BCMA-directed BiTE molecules as a therapeutic approach in multiple myeloma. AMG 701 continues to show the potential of that strategy in patients who are heavily pre-treated," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.

"These data are the latest in a series that reinforce both the potential versatility of the BiTE platform and Amgen's commitment to developing innovative medicines for novel targets in difficult-to-treat cancers," Reese continued. "This year alone, Amgen has presented proof-of-concept data for four BiTE^® molecules in hematological malignancies and solid tumors, and we are proud to end the year with these data in multiple myeloma at ASH."

This interim analysis of the Phase 1 dose escalation study evaluated AMG 701 in 85 R/R MM patients who had received at least three prior lines of therapy, and a median of six lines. The response rate was 36% at doses of 3-18 mg with responses lasting up to 26 months in one patient. Six of seven patients, who were tested for minimal residual disease (MRD), were MRD-negative. In the most recent evaluable cohort, there was an 83% ORR, with 4/5 responders being triple refractory.

"Despite advances in the treatment of multiple myeloma, there remains an unmet need for patients with this difficult-to-treat disease who have relapsed or refractory disease following current standard therapies," said Professor Simon J. Harrison, director of the Centre of Excellence in Cellular Immunotherapy, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Australia. "These first-in-human data show that AMG 701, a half-life extended BiTE therapy targeting BCMA, has encouraging signs of activity as a single agent in this heavily pre-treated patient population."

The most common hematological adverse events (AEs) were anemia (42%), neutropenia (25%) and thrombocytopenia (21%). The most common non-hematological AEs were cytokine release syndrome (CRS, 65%), diarrhea (31%) and hypophosphatemia (31%). CRS was mostly grade 1 (27%) or 2 (28%) based on Lee Blood 2014 criteria. All Grade 3 CRS events (9%) were reversible with mitigation procedures outlined in the study protocol, with a median duration of two days.

Learn more about Amgen's development of innovative medicines for novel targets in difficult-to-treat tumors at AmgenOncology.com/medical, and follow Amgen Oncology on Twitter and LinkedIn.

About BiTE^® Technology

BiTE^® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient's 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 has a goal of leading 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. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.¹ It is a rare and life-threatening disease that accounts for approximately one percent of all cancers.^2,3 Worldwide, approximately 160,000 people are diagnosed with multiple myeloma each year, and 106,000 patient deaths are reported on an annual basis.²

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 patient's 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.

About Amgen

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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla^® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631 (media)
Jessica Akopyan, 805-447-0974 (media)
Arvind Sood, 805-447-1060 (investors)

References

1. Kumar S., et al. NCCN Guidelines Insights: Multiple Myeloma. The Journal of the National Comprehensive Cancer Network. Jan 2018; Volume 16: Issue 1. https://doi.org/10.6004/jnccn.2018.0002.
2. Jakubowiak A. Management strategies for relapsed/refractory multiple myeloma: current clinical perspectives. Semin Hematol. 2012 Jul; 49 Suppl 1: S16-S32.
3. GLOBOCAN 2018. Multiple Myeloma. Available at: http://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf. Accessed November 9, 2020.

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SOURCE Amgen