Amgen Presents First Clinical Data for AMG 757 at SITC 2020

THOUSAND OAKS, Calif., Nov. 9, 2020 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the first presentation of AMG 757 Phase 1 clinical safety and efficacy data in relapsed or refractory small cell lung cancer (SCLC). AMG 757 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE(®)) molecule targeting delta-like ligand 3 (DLL3). The DLL3 protein is overexpressed on the cell surface of SCLC tumors and minimally expressed in normal tissues.(1 )Data will be featured during a live oral presentation on Nov. 12 at the Society for Immunotherapy of Cancer's (SITC) 35(th) Annual Meeting being held virtually.

"These AMG 757 proof of concept data in small cell lung cancer and the recently presented AMG 160 data in prostate cancer provide encouraging evidence of the BiTE platform's clinical activity in solid tumors," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "AMG 757 is a half-life extended BiTE immuno-oncology molecule targeting DLL3, which is an attractive target due to its differential expression in small cell lung cancer. Small cell lung cancer is a large unmet medical need globally, and yet treatment options have not advanced significantly in decades."

This interim analysis of the Phase 1 dose escalation study evaluated 40 patients with relapsed/refractory SCLC at a dose of up to 10 mg every two weeks. In this study, AMG 757 demonstrated an acceptable safety profile and showed preliminary evidence of anti-tumor activity. Among 38 patients with evaluable disease, 16% (6) had confirmed partial response, 29% (11) had stable disease, and 3% (1) had unconfirmed partial response. Five of the six responses are on-going with a median follow-up of 8.8 months. The maximum tolerated dose for AMG 757 has not been reached and dosing optimization is ongoing.

Cytokine release syndrome (CRS) was the most common treatment-related adverse event (AE) reported in 43% (17) of patients. All CRS events were grade 1 (30%) or 2 (13%), typically occurred in cycle 1, and did not recur in subsequent cycles. All CRS events were reversible, manageable, and did not lead to treatment interuptions or discontinations.

"Small cell lung cancer is an aggressive cancer resulting in poor prognosis for patients. Current platinum-based chemotherapy and immunotherapy options have limited benefit in patients with small cell lung cancer, leaving patients in need of novel therapeutic options," said Hossein Borghaei, DO, MS, chief of thoracic medical oncology at Fox Chase Cancer Center. "These early data of AMG 757 are encouraging for a BiTE immuno-oncology molecule that targets DLL3 in small cell lung cancer."

Additional Data Presentations
Data on IMLYGIC(®) (talimogene laherparepvec) will be featured during an oral presentation. Data on AMG 404, AMG 160, and AMG 509 will be presented as poster presentations. More information can be found on the SITC website here.

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-associated 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-associated 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

About IMLYGIC(®) (talimogene laherparepvec)
IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. The exact mechanism of action continues to be investigated.

IMLYGIC is the first and only oncolytic viral therapy approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory authorities, based on therapeutic benefit demonstrated in a pivotal Phase 3 study. IMLYGIC is indicated for the local treatment of melanoma in patients with unresectable cutaneous, subcutaneous, or nodal lesions after initial surgery.

The IMLYGIC clinical program continues to investigate the role of IMLYGIC both as monotherapy and in combination with other therapies across a variety of cancers and treatment settings.

IMLYGIC(®) (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Limitations of use: IMLYGIC(®) has not been shown to improve overall survival or have an effect on visceral metastases.



    --  Do not administer IMLYGIC(®) to immunocompromised patients, including
        those with a history of primary or acquired immunodeficient states,
        leukemia, lymphoma, AIDS or other clinical manifestations of infection
        with human immunodeficiency viruses, and those on immunosuppressive
        therapy, due to the risk of life-threatening disseminated herpetic
    --  Do not administer IMLYGIC(®) to pregnant patients.

Warnings and Precautions

    --  Accidental exposure to IMLYGIC(®) may lead to transmission of
        IMLYGIC(®) and herpetic infection, including during preparation and
        administration. Health care providers, close contacts, pregnant women,
        and newborns should avoid direct contact with injected lesions,
        dressings, or body fluids of treated patients. The affected area in
        exposed individuals should be cleaned thoroughly with soap and water
        and/or a disinfectant.
    --  Caregivers should wear protective gloves when assisting patients in
        applying or changing occlusive dressings and observe safety precautions
        for disposal of used dressings, gloves, and cleaning materials. Exposed
        individuals should clean the affected area thoroughly with soap and
        water and/or a disinfectant.
    --  To prevent possible inadvertent transfer of IMLYGIC(®) to other areas
        of the body, patients should be advised to avoid touching or scratching
        injection sites or occlusive dressings.
    --  Herpetic infections: Herpetic infections (including cold sores and
        herpetic keratitis) have been reported in IMLYGIC(®)-treated patients.
        Disseminated herpetic infection may also occur in immunocompromised
        patients. Patients who develop suspicious herpes-like lesions should
        follow standard hygienic practices to prevent viral transmission.
    --  Patients or close contacts with suspected signs or symptoms of a
        herpetic infection should contact their health care provider to evaluate
        the lesions. Suspected herpetic lesions should be reported to Amgen at
        1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the
        option of follow-up testing for further characterization of the
    --  IMLYGIC(®) is sensitive to acyclovir. Acyclovir or other antiviral
        agents may interfere with the effectiveness of IMLYGIC(®). Consider the
        risks and benefits of IMLYGIC(®) treatment before administering
        antiviral agents to manage herpetic infection.
    --  Injection Site Complications: Necrosis or ulceration of tumor tissue may
        occur during IMLYGIC(®) treatment. Cellulitis and systemic bacterial
        infection have been reported in clinical studies. Careful wound care and
        infection precautions are recommended, particularly if tissue necrosis
        results in open wounds.
    --  Impaired healing at the injection site has been reported. IMLYGIC(®)
        may increase the risk of impaired healing in patients with underlying
        risk factors (e.g., previous radiation at the injection site or lesions
        in poorly vascularized areas). If there is persistent infection or
        delayed healing of the injection site, consider the risks and benefits
        of continuing treatment.
    --  Immune-Mediated events including glomerulonephritis, vasculitis,
        pneumonitis, worsening psoriasis, and vitiligo have been reported in
        patients treated with IMLYGIC(®). Consider the risks and benefits of
        IMLYGIC(®) before initiating treatment in patients who have underlying
        autoimmune disease or before continuing treatment in patients who
        develop immune-mediated events.
    --  Plasmacytoma at the Injection Site: Plasmacytoma in proximity to the
        injection site has been reported in a patient with smoldering multiple
        myeloma after IMLYGIC(®) administration in a clinical study. Consider
        the risks and benefits of IMLYGIC(®) in patients with multiple myeloma
        or in whom plasmacytoma develops during treatment.
    --  Obstructive Airway Disorder: Obstructive airway disorder has been
        reported following IMLYGIC(®) treatment. Use caution when injecting
        lesions close to major airways.

Adverse Reactions

    --  The most commonly reported adverse drug reactions (>= 25%) in
        IMLYGIC(®)-treated patients were fatigue, chills, pyrexia, nausea,
        influenza-like illness, and injection site pain. Pyrexia, chills, and
        influenza-like illness can occur at any time during IMLYGIC(®)
        treatment, but were more frequent during the first 3 months of

The most common Grade 3 or higher adverse reaction was cellulitis. Please see for full Prescribing Information, including Medication Guide.

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

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 and follow us on

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CONTACT: Amgen, Thousand Oaks
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    1. Saunders LR, et al. Sci Transl Med 2015;7:302ral36.

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