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Acute lymphoblastic leukemia

Acute lymphoblastic leukemia (ALL) is an aggressive leukemia characterized by a proliferation of lymphoblasts or lymphocytes in the blood and bone marrow. It can metastasize to the lymph nodes, spleen, liver, central nervous system, and other organs. ALL can progress quickly.1

ALL is relatively uncommon—but serious: approximately 6,000 cases are diagnosed in the US annually, with 25% of patients dying from the disease. ALL likely begins with the malignant transformation of either B or T cell progenitor cells. The surface of these cells typically express CD10, CD19, and CD34, which could be potential targets for the development of effective new treatments.1

CD: cluster of differentiation.

Molecule(s) under investigation:
Blinatumomab

Reference
1. National Cancer Institute, Adult acute lymphoblastic leukemia treatment (PDQ®)—health professional version. https://www.cancer.gov/types/leukemia/hp/adult-all-treatment-pdq. Accessed 4/17/2019.

Acute myeloid leukemia

Acute myeloid leukemia (AML) is an aggressive leukemia where an excess of myeloblasts are found in the blood and bone marrow.1Mortality remains high in patients with AML: of the estimated 21,000 cases diagnosed in the US in 2019, almost 11,000 will die, revealing a clear and urgent unmet need for better treatment options.2

Complete remission (CR) is an essential treatment goal in AML, as partial remission confers no substantial survival benefit. With current treatment options, approximately 60% to 70% of patients achieve CR, and approximately 45% of these patients can be expected to survive 3 or more years.3

Molecule(s) under investigation:
AMG 176
AMG 330
AMG 397
AMG 427
AMG 553
AMG 673

Reference
1. National Cancer Institute, Adult acute myeloid leukemia treatment (PDQ®)—patient version. https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq. Accessed 4/17/2019. 2.American Cancer Society. Cancer Facts & Figures 2019.Atlanta: American Cancer Society; 2019. 3.National Cancer Institute, Adult acute myeloid leukemia treatment (PDQ®)—health professional version. https://www.cancer.gov/types/leukemia/hp/adult-aml-treatment-pdq. Accessed 4/17/2019.

Breast cancer

Although breast cancer survival has improved with enhanced detection and new treatment options, more than a quarter of a million new cases continue to be diagnosed in the US every year, resulting in more than 40,000 deaths.1

HER2+ status carries a diminished prognosis compared with other mutations, making it essential that patients have access to HER2-targeted treatment options.1

Molecule(s) under investigation:
ABP 980

Reference
1.American Cancer Society, Breast Cancer Facts & Figures 2017-2018. Atlanta: American Cancer Society, Inc. 2017.

Colorectal cancer

In 2019, there will be an estimated 100,000 new cases of colon cancer and 44,000 new cases of rectal cancer in the United States. Overall incidence of colorectal cancer (CRC) has been declining over the past several decades, but rates are increasing for patients under the age of 55. This increase led the American Cancer Society to update recommendations in 2018 to begin screening at age 45 for people of average risk.1

Risk factors for CRC include obesity, physical inactivity, smoking and alcohol use, diet, and a family history of the disease. The 5-year survival rate for CRC is 65% for all stages and 14% for patients diagnosed with metastatic disease.1

Molecule(s) under investigation:
AMG 510

Reference
1.American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019.

GASTRIC CANCER

It is estimated that more than 27,000 Americans will be diagnosed with gastric cancer in 2019, and more than 11,000 will die from the disease.1 Chemotherapy has shown some benefit, but overall the prognosis for most patients remains extremely poor.2,3

The discovery that up to 25% of gastric cancers overexpress HER2 led to the promise of a targeted approach.4

Molecule(s) under investigation:
ABP 980 is a biosimilar anti-HER2 agent. ABP 980 is not being actively studied in gastric cancer, but may be granted this indication on approval if an extrapolation to gastric cancer is considered scientifically justified by regulatory authorities after careful consideration.

Reference
1. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019. 2. National Cancer Institute, Cancer stat facts: stomach cancer. https://seer.cancer.gov/statfacts/html/stomach.html. Accessed 4/17/2019. 3. Cunningham D, Allum WH, Stenning SP, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006;355(1):11-20. 4. Gunturu KS, Woo Y, Beaubier N, Remotti HE, Saif MW. Gastric cancer and trastuzumab: first biologic therapy in gastric cancer. Ther Adv Med Oncol. 2013;5(2):143-151.

Glioblastoma

Glioblastoma (also called glioblastoma multiforme or GBM) is the most common form of brain tumor. Tumors of the brain and central nervous system carry a high rate of mortality; three-quarters of the nearly 24,000 patients who are diagnosed die every year.1

Glioblastomas are predominantly composed of abnormal astrocytic cells and may be IDH–wild-type or IDH-mutant. IDH wild-type are more common, more aggressive, and carry a poorer prognosis than IDH-mutant tumors. Treatment is usually multidisciplinary, based on the types of cells involved; however, the prognosis is generally grim, with a low median survival based on currently approved treatment options.2

IDH: isocitrate dehydrogenase.

Molecule(s) under investigation:
AMG 596

Reference
1. National Cancer Institute, Adult central nervous system tumors treatment (PDQ®)—health professional version. https://www.cancer.gov/types/brain/hp/adult-brain-treatment-pdq. Accessed 4/17/2019. 2. American Brain Tumor Association, Glioblastoma (GBM). https://www.abta.org/tumor_types/glioblastoma-gbm. Accessed 4/17/2019.

Graft versus host disease

Graft versus host disease (GvHD) occurs when T cells donated during allogeneic HSCT attack healthy tissue in the host.1 Acute GvHD is transient and occurs soon after transplantation, usually affecting the skin, liver, and GI tract.1,2

Chronic GvHD, on the other hand, is one of the leading causes of complications and death following allogeneic hematopoietic stem cell transplantation. It affects up to 70% of patients and may involve one or more organs. Efforts are usually focused on preventing the development of chronic GvHD as it is difficult to treat once established.1

Molecule(s) under investigation:
AMG 592

Reference
1.Leukemia & Lymphoma Society, Graft-versus-host disease. https://www.lls.org/treatment/types-of-treatment/stem-cell-transplantation/graft-versus-host-disease. Accessed 4/17/2019. 2.Toubai T, Sun Y, Reddy P. GVHD pathophysiology: is acute different from chronic? Best Pract Res Clin Haematol. 2008;21(2):101-117.

Hepatocellular carcinoma

It has been estimated that liver cancer, which includes hepatocellular carcinoma (HCC) and intrahepatic bile duct cancer, will have more than 42,000 new cases in the US in 2019.1 Factors that increase the risk of HCC include hepatitis B and/or C infection, cirrhosis, and metabolic disorders or liver injury.2

Liver transplant or resection of early disease offers a high chance for a cure, but fewer than 25% of patients are candidates for surgery with a curative intent. In randomized clinical trials, overall survival at 2 years ranges from 8% to 50%, highlighting a clear unmet need of improved treatment approaches.2

Molecule(s) under investigation:
Talimogene laherparepvec (T-VEC)

Reference
1. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019. 2. National Cancer Institute, Adult primary liver cancer treatment (PDQ®)—health professional version. https://www.cancer.gov/types/liver/hp/adult-liver-treatment-pdq. Accessed 4/19/2019.

Head and neck cancer

Cancers that begin in the squamous cells that line the mucosa of the head and neck (mouth, nose, and throat) are collectively called head and neck squamous cell carcinoma (HNSCC). An estimated 65,000 diagnoses were made in the US in 2017.1

The risk of head and neck cancer typically increases with tobacco and alcohol use as well as infection with the human papillomavirus (HPV). HPV infection is also an important prognostic factor that can impact treatment approach.1

Molecule(s) under investigation:
Talimogene laherparepvec (T-VEC)

Reference
1.National Cancer Institute, Head and neck cancers. https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet. Accessed 4/17/2019.

Lung cancer

Despite recent advances, lung cancer remains by far the deadliest cancer in the US. In 2019, it is estimated that lung cancer will kill more people than the 2nd through 4th deadliest cancers combined—with more than 142,000 deaths and 228,000 new diagnoses.1

Most research and development to date has focused on non-small-cell lung cancer (NSCLC), which accounts for 75% to 85% of all cases. Although less common, small-cell lung cancer (SCLC) is more aggressive; it carries a worse prognosis, metastasizing rapidly and sometimes leading to death in a matter of weeks.2 Amgen is focusing especially on these underserved patients.

Molecule(s) under investigation:
AMG 119
AMG 510
AMG 757

Reference
1. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019. 2. Crivellari G, Monfardini S, Stragliotto S, Marino D, Aversa SML. Increasing chemotherapy in small-cell lung cancer: from dose intensity and density to megadoses. Oncologist. 2007;12(1):79-89.

Melanoma

Skin cancer is the most common cancer diagnosis in the US. It is estimated that there will be over 7,000 skin cancer deaths in 2019.1,2 Invasive melanoma—which accounts for only 1% of skin cancer diagnoses—causes the most deaths.1

Like most cancers, the risk of melanoma rises with age,3 but it is the most common cancer in young adults aged 25 to 29 years and the second most common in those aged 15 to 29 years. And despite well-recognized and avoidable risk factors, the incidence of melanoma continues to rise.1 With such high mortality rates—and high stakes—a continued search for enhanced treatment approaches is vital.

Molecule(s) under investigation:
Talimogene laherparepvec (T-VEC)

Reference
1. National Cancer Institute, Melanoma treatment (PDQ®)—health professional version. https://www.cancer.gov/types/skin/hp/melanoma-treatment-pdq. Accessed 4/17/2019. 2. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019. 3. American Cancer Society, Key Statistics for Melanoma Skin Cancer. https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html. Accessed 4/17/2019.

Multiple myeloma

Multiple myeloma is the second-most common blood cancer.1 In the US, it is estimated that there will be nearly 32,000 new cases in 2019, and almost 13,000 deaths.2 Despite increased availability of novel agents, the disease is characterized by a pattern of recurrent relapses and remains incurable for the majority of patients.2,3

Multiple myeloma is a B cell malignancy in which abnormal, clonal plasma cells proliferate and accumulate in the bone marrow, causing bone destruction.4 Myeloma cells have increased dependence on proteasome function.5,6 The proteasome also activates nuclear factor kappa B (NF-κB) signaling, which upregulates antiapoptotic factors, cell adhesion molecules, cytokines, and growth factors that promote survival of myeloma cells.6-8 This makes the proteasome and apoptotic factors promising targets.

Molecule(s) under investigation:
AMG 176
AMG 397
AMG 420
AMG 424
AMG 701
Carfilzomib

Reference
1. Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2018. CA Cancer J Clin. 2018;68(1):7-30. 2. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019. 3. Durie BGM, Moreau P, Sonneveld P, et al. Regional differences in the treatment approaches for relapsed multiple myeloma: An IMF study. J Clin Oncol. 2012;30(suppl 15): Abstract 8095. 4. National Cancer Institute, Cancer stat facts: myeloma. https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed 4/17/2019. 5. Moreau P, Richardson PG, Cabo M, et al. Proteasome inhibitors in multiple myeloma: 10 years later. Blood. 2012;120(5):947-959. 6. Kubiczkova L, Pour L, Sedlarikova L, Hajek R, Sevcikova S. Proteasome inhibitors—molecular basis and current perspectives in multiple myeloma. J Cell Mol Med. 2014;18:947-961. 7. Palumbo A, Anderson K. Multiple Myeloma. N Engl J Med. 2011;364(11):1046-1060. 8. Chen D, Frezza M, Schmitt S, Kanwar J, P Dou Q. Bortezomib as the first proteasome inhibitor anticancer drug: current status and future perspectives. Curr Cancer Drug Targets. 2011;11(3):239-253.

Non-Hodgkin lymphoma

Non-Hodgkin lymphomas (NHL) represent a heterogenous group of lymphoproliferative malignancies that generally originate in lymphoid tissue.1 It is estimated that there will be over 74,000 new cases in 2019 and nearly 20,000 deaths.2 Across the group, there exist a range of disease patterns and treatment responses, making generalizations difficult.1

NHL is far more common than Hodgkin lymphoma, less predictable, and more likely to spread to extranodal sites.1,3 DLBCL is the most common form of NHL (22%), followed by CLL/SLL (18%) and FL (11%).4,5 DLBCL is a fast-growing lymphoma.4 “Dismal” outcomes for relapsed or refractory DLBCL demonstrate a clear need for more effective therapeutic options.6

Molecule(s) under investigation:
AMG 397
AMG 562
Blinatumomab
ABP 798

Reference
1. National Cancer Institute. Adult non-Hodgkin lymphoma treatment (PDQ®)—health professional version. https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq. Accessed 4/16/2019. 2. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019. 3. Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2018. CA Cancer J Clin. 2018;68(1):7-30. 4. Lymphoma Research Foundation, Diffuse large B-cell lymphoma. https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl. Accessed 4/16/2019. 5. Lymphoma Research Foundation, Non-Hodgkin lymphoma. https://www.lymphoma.org/aboutlymphoma/nhl. Accessed 4/16/2019. 6. Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808.

Pediatric solid tumors

Although many hematologic malignancies are among the most common cancers in children and young adults, solid tumors remain a major challenge; overall, cancer is the leading cause of death from disease among children.1,2

The most common solid tumors in children are found in the brain and central nervous system.1 As they progress to adolescence and young adulthood (age 15+), testicular cancer, thyroid cancer, and sarcomas become more common. Breast, melanoma, cervical, liver, germ-cell, and colorectal cancers are also among those seen in adolescents and young adults.2

Given the unique biology and challenges associated with cancer in pediatric patients, this area represents a special and critical focus for continued research.1,2

Molecule(s) under investigation:
Talimogene laherparepvec (T-VEC)

Reference
1. National Cancer Institute. Childhood cancers. https://www.cancer.gov/types/childhood-cancers. Accessed 4/16/2019. 2. National Cancer Institute. Adolescents and young adults with cancer. https://www.cancer.gov/types/aya. Accessed 4/16/2019.

Paroxysmal nocturnal hemoglobinuria

Paroxysmal nocturnal hemoglobinuria, or PNH (also called Marchiafava-Micheli disease), is an acquired disorder that leads to the premature destruction and impaired production of erythrocytes. It is usually diagnosed in young adulthood and is caused by acquired mutations in the PIGA gene.1 There are approximately 1 to 1.5 cases per million individuals worldwide diagnosed with this rare condition.2

PNH leads to recurring episodes of hemolysis-related symptoms such as fatigue, pallor, dyspnea, and tachycardia. More serious sequelae may include infections, thrombosis or hemorrhage, and patients are at an increased risk for the development of leukemia.1 Inhibition of complement component 5 (C5) is currently the only way to impact the underlying mechanism of disease.2 The availability of biosimilar anti-C5 agents may provide additional treatment options for patients with PNH.

Molecule(s) under investigation:
ABP 959

Reference
1. NIH Genetic and Rare Diseases Information Center. Paroxysmal nocturnal hemoglobinuria. https://rarediseases.info.nih.gov/diseases/7337/paroxysmal-nocturnal-hemoglobinuria. Accessed 4/16/2019. 2. Wong EKS, Kavanagh D. Diseases of complement dysregulation—an overview. Semin Immunopathol. 2018;40(1):49-64.

Prostate cancer

Early detection and a range of treatments have made prostate cancer quite manageable for most of the men diagnosed (estimated to be more than 174,000 in 2019); but there remains an unmet need for new treatment options in patients with advanced, castrate-resistant disease (CRPC), which is responsible for nearly all prostate cancer-related deaths.1,2 It is estimated that over 31,000 men will die from prostate cancer in 2019.1

Unlike prostate-specific antigen (PSA), prostate-specific membrane antigen (PSMA) has the potential to serve as both a radiodiagnostic marker and as a target for new therapies.3 Targeting immune cells to PSMA-expressing cells has been shown to produce a clinical response.4 In addition, PSMA is expressed by the neovasculature of a range of malignancies but not by normal blood vessels, making it a potential target for other solid tumors as well.3

Molecule(s) under investigation:
AMG 160
AMG 212

Reference
1. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019. 2. Lee DJ, Cha EK, Dubin JM, et al. Novel therapeutics for the management for the management of castration-resistant prostate cancer (CRPC). BJU Int. 2012;109(7):968-985. 3. Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6(Suppl 10):S13-18. 4. Salgaller ML, Lodge PA, McLean JG, et al. Report of immune monitoring of prostate cancer patients undergoing T-cell therapy using dendritic cells pulsed with HLA-A2-specific peptides from prostate-specific membrane antigen (PSMA). Prostate. 1998;35(2):144-151.

Thrombocytopenia

Thrombocytopenia (low platelet count) is a common complication in patients with cancer, most often resulting from the use of chemotherapy.1,2 Symptoms include excessive bleeding, increased bruising (purpura), petechiae, bloody stools or urine, severe headaches, visual disturbances, confusion, and fatigue.2

Importantly, chemotherapy-induced thrombocytopenia (CIT) can lead to reductions in the dose and/or frequency of chemotherapy, compromising patient survival. The incidence of severe CIT is 3% to 4%, with some patients requiring platelet transfusions. Dose reductions are common, reflecting an unmet clinical need for effective thrombopoietic agents that can prophylactically sustain platelet levels to allow maintenance of chemotherapy dose density and intensity.1

Molecule(s) under investigation:
Romisplostim

Reference
1. Hassan MN, Waller EK. Treating chemotherapy-induced thrombocytopenia: is it time for oncologists to use thrombopoietin agonists? Oncology (Williston Park). 2015;29(4):295-296. 2. National Cancer Institute. Bleeding and bruising (thrombocytopenia) and cancer treatment. https://www.cancer.gov/about-cancer/treatment/side-effects/bleeding-bruising. Accessed 4/16/2019.

Other solid tumors

The treatment of solid tumors has undergone multiple revolutions in the last generation. Many types of chemotherapy are available to disrupt the cell cycle, as well as hormone therapies for certain tumors. A better understanding of pathogenesis has led to the development of targeted therapies such as monoclonal antibodies and kinase inhibitors.1

Now immunotherapies are used to activate the immune system against a growing number of solid tumors.1,2 Some of the advances currently under investigation include bispecific antibodies, checkpoint inhibitors, oncolytic viruses, and CAR T cell therapies—as well as combinations including one or more of these approaches.2

There is still much to discover in the treatment of solid tumors.

Molecule(s) under investigation:
AMG 404
AMG 510
Talimogene laherparepvec (T-VEC)

Reference
1. Gatzka MV. Targeted tumor therapy remixed—an update on the use of small-molecule drugs in combination therapies. Cancers (Basel). 2018;10(6). doi:10.3390/cancers10060155. 2. American Cancer Society. What’s new in cancer immunotherapy research? https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/whats-new-in-immunotherapy-research.html. Accessed 4/16/2019.

All clinical trial information current as of 10/8/2019.

Please note that trial status and parameters may change at any time; please contact a trial site or investigator for the latest information on a given trial.

Amgen’s product pipeline will change over time as molecules move through the drug development process, including processing to market or failing in clinical trials, due to the nature of the development process. The descriptions herein contain forward-looking statements that involve significant risks and uncertainties, including those discussed in Amgen’s most recent Form 10-K and in Amgen’s periodic reports on Form 10-Q and Form 8-K, and actual results may vary materially. Amgen is providing this information as of the date above and does undertake any obligation to update any forward-looking statements contained in this table as a result of new information, future events or otherwise.

XmAb ® bispecific antibody developed in collaboration with Xencor.