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Amgen Showcases New Data From Oncology Pipeline And Portfolio At ESMO 2019

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THOUSAND OAKS, Calif., Sept. 17, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that new data from its oncology pipeline and marketed product portfolio will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, Sept. 27-Oct. 1, 2019.

Clinical data presentations will include a poster discussion on the ongoing Phase 1 trial of AMG 510, highlighting responses in KRAS G12C-mutant solid tumors, including patients with advanced non-small cell lung, colorectal and appendiceal cancers. AMG 510 is the first KRASG12C inhibitor to reach the clinical stage in patients with locally advanced or metastatic KRAS G12C-mutated solid tumors.

Data showing the two-year results of a Phase 2 trial in patients with neoadjuvant melanoma being treated with IMLYGIC® (talimogene laherparepvec) plus surgery versus immediate surgery will be presented as a late-breaking abstract in an oral presentation. A second late-breaking abstract featuring IMLYGIC will be presented in a poster discussion session, highlighting three-year follow-up data of a Phase 2 trial with IMLYGIC in combination with YERVOY® (ipilimumab) for advanced melanoma.

"The data being presented at ESMO demonstrate how Amgen is advancing the next frontier of innovation in the treatment of cancers," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "In addition to the responses seen in non-small cell lung cancer patients with KRAS G12C-mutant tumors, we will report the first responses in advanced colorectal and appendiceal cancers at the upcoming congress."

A complete listing of abstracts can be found on the ESMO website. Notable abstracts of interest include:

Oncology Pipeline

  • Phase 1 Study of AMG 510, a Novel Molecule Targeting KRAS G12C-Mutant Solid Tumors
    Abstract #446PD, Poster Discussion, Saturday, Sept. 28, session at 4:30 p.m. CEST, discussion at 4:52 p.m. CEST in Alicante Auditorium (Hall 3)

  • A Phase 1 Study of AMG 160, a Half-Life Extended Bispecific T-Cell Engager (HLE BiTE®) Immuno-Oncology Therapy Targeting PSMA, in Patients (pts) With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
    Abstract #895TiP, Poster Presentation, Monday, Sept. 30, at noon CEST in Poster Area (Hall 4), Fira Gran Via

IMLYGIC

  • Primary 2-Year Results of the Phase 2, Multicenter, Randomized, Open-Label Trial of Efficacy and Safety for Talimogene Laherparepvec (T-VEC) Neoadjuvant (neo) Treatment (tx) Plus Surgery vs. Immediate Surgery in Patients (pts) With Resectable Stage IIIB-IVM1a Melanoma
    Abstract #LBA66, Oral Presentation, Saturday, Sept. 28, session and lecture at 8:30 a.m. CEST in Cordoba Auditorium (Hall 7)

  • Talimogene Laherparepvec (T-VEC) in Combination (combo) With Ipilimumab (ipi) Versus ipi Alone for Advanced Melanoma: 3-Year Landmark Analysis of a Randomized, Open-Label Phase 2 Trial
    Abstract #LBA70, Poster Discussion, Saturday, Sept. 28, session and discussion at 2:45 p.m. CEST in Granada Auditorium (Hall 3)

  • Efficacy of Talimogene Laherparepvec (T-VEC) in Melanoma Patients (pts) With Locoregional Recurrence, Including In-transit Metastases (ITM): Subgroup Analysis of the Phase III OPTiM Study
    Abstract #1342P, Poster Presentation, Monday, Sept. 30, at noon CEST in Poster Area (Hall 4), Fira Gran Via

XGEVA® (denosumab)

  • Use of Skeletal-Related Events Preventative Agents in Patients With Solid Tumors and Bone Metastases in Central Denmark
    Abstract #1793P, Poster Presentation, Saturday, Sept. 28, at noon CEST in Poster Area (Hall 4), Fira Gran Via

  • Adherence to ESMO 2014 Guidelines on Bone-Targeting Agent Initiation for Breast and Prostate Cancer Patients: Real-World Insights From Practicing European Physicians
    Abstract #1792P, Poster Presentation, Saturday, Sept. 28, at noon CEST in Poster Area (Hall 4), Fira Gran Via

  • Patterns of Care for Patients With Metastatic Bone Disease in Solid Tumors – a Cross-Sectional Study (SAKK 95/16)
    Abstract #1797P, Poster Presentation, Saturday, Sept. 28, at noon CEST in Poster Area (Hall 4), Fira Gran Via

  • Utilization Pattern of Bone Targeting Agents in Patients With Solid Tumor in Taiwan, Hong Kong and Korea
    Abstract #379P, Poster Presentation, Sunday, Sept. 29, at noon CEST in Poster Area (Hall 4), Fira Gran Via

Vectibix® (panitumumab)

  • Sequential RAS Mutation Testing in cfDNA in RAS Wild Type (wt) Metastatic Colorectal Cancer (mCRC) Patients (p) Treated With Panitumumab (P) and Chemotherapy (CT) in First Line (1L) PERSEIDA Study
    Abstract #531PD, Poster Discussion, Sunday, Sept. 29, session at 3 p.m. CEST, discussion at 3:25 p.m. CEST in Cordoba Atrium (Hall 7), Fira Gran Via

  • Early Tumour Shrinkage (ETS), Depth of Response (DpR) and Associated Survival Outcomes in Patients (pts) With RAS Wild Type (WT) Metastatic Colorectal Cancer (mCRC) Classified According to Köhne Prognostic Category: Retrospective Analysis of the Panitumumab (Pmab) PRIME Study
    Abstract #572P, Poster Presentation, Sunday, Sept. 29, at noon CEST in Poster Area (Hall 4), Fira Gran Via

  • Middle East & North Africa Registry to Characterize RAS Mutation Status and Tumor Specifications in Recently Diagnosed Patients With Metastatic Colorectal Cancer (MORE-RAS Study)
    Abstract #656P, Poster Presentation, Sunday, Sept. 29, at noon CEST in Poster Area (Hall 4), Fira Gran Via

  • Quality of Life During 1st-Line FOLFOXIRI+/- Panitumumab in RAS Wild-type Metastatic Colorectal Cancer: Results From the Randomized VOLFI Trial (AIO KRK-0109)
    Abstract #580P, Poster Presentation, Sunday, Sept. 29, at noon CEST in Poster Area (Hall 4), Fira Gran Via

  • Final Results of a Phase II Study of Induction Chemotherapy (CT) With Paclitaxel (PTX) and Panitumumab (P) Followed by Radiotherapy (RT) and P in Patients (pts) With Locally Advanced Head and Neck Cancer (LAHNC) No Candidates to Platinum: Study PANTERA
    Abstract #1128P, Poster Presentation, Monday, Sept. 30, at noon CEST in Poster Area (Hall 4), Fira Gran Via

About KRAS
The subject of more than three decades of research, the RAS gene family are the most frequently mutated oncogenes 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 KRAS G12C accounts for approximately 13% of non-small cell lung cancers, three to five percent of colorectal cancers and one to two percent of numerous other solid tumors.3 Approximately 30,000 patients are diagnosed each year in the United States (U.S.) with KRAS G12C-driven cancers.4 KRASG12C has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein. 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 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. However, the exact mechanism of action is unknown.

IMLYGIC is the first oncolytic viral therapy approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) based on therapeutic benefit demonstrated in a pivotal study. IMLYGIC 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. IMLYGIC has not been shown to improve overall survival (OS) or have an effect on visceral metastases.

INDICATION & LIMITATIONS OF USE
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.

IMPORTANT SAFETY INFORMATION

Contraindications

  • 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 infection.
  • 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 infection.
  • 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 (eg, 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 treatment.
  • The most common Grade 3 or higher adverse reaction was cellulitis.

Please see www.Imlygic.com for full Prescribing Information, including Medication Guide.

About XGEVA® (denosumab)
XGEVA targets the RANKL pathway to prevent the formation, function and survival of osteoclasts, which break down bone. XGEVA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. XGEVA is also indicated for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

INDICATIONS
XGEVA® is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. XGEVA® is indicated for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. XGEVA® is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

IMPORTANT SAFETY INFORMATION

Important Safety Information

Hypocalcemia
Pre-existing hypocalcemia must be corrected prior to initiating therapy with XGEVA®. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Monitor calcium levels, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Monitor levels more frequently when XGEVA® is administered with other drugs that can also lower calcium levels. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.

Hypersensitivity
XGEVA® is contraindicated in patients with known clinically significant hypersensitivity to XGEVA®, including anaphylaxis that has been reported with use of XGEVA®. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue XGEVA® therapy permanently.

Drug Products with Same Active Ingredient
Patients receiving XGEVA® should not take Prolia® (denosumab).

Osteonecrosis of the Jaw
Osteonecrosis of the jaw (ONJ) has been reported in patients receiving XGEVA®, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure.

Patients with a history of tooth extraction, poor oral hygiene, or use of a dental appliance are at a greater risk to develop ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.

Perform an oral examination and appropriate preventive dentistry prior to the initiation of XGEVA® and periodically during XGEVA® therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with XGEVA®. Consider temporarily interrupting XGEVA® therapy if an invasive dental procedure must be performed.

Patients who are suspected of having or who develop ONJ while on XGEVA® should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

Atypical Subtrochanteric and Diaphyseal Femoral Fracture
Atypical femoral fracture has been reported with XGEVA®. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During XGEVA® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of XGEVA® therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with Growing Skeletons
Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in XGEVA®-treated patients with GCTB and in patients with growing skeletons within one year of treatment discontinuation. Mon

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