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Amgen Takes on One of Cancer’s Toughest Challenges

Nearly four decades have passed since researchers first identified the RAS gene family, which is the most frequently mutated oncogene family in human cancers.[1],[2] While research efforts were able to identify and develop treatments for other driver gene mutations that contribute to cancer growth, similar success with KRAS, the most frequently mutated variant of RAS, remained elusive.2 As a result, clinicians and oncologists have spent decades trying to best help patients with KRAS mutations using available cancer treatments, but patients remain in dire need of more therapy options.

A specific KRAS mutation known as KRAS G12C, has been identified as a driver of many solid tumors and is particularly prevalent in non-small cell lung cancer (NSCLC).1,2 Despite this prevalence, there are currently no approved targeted therapy options for KRAS G12C. In the U.S., KRAS G12C represents one of the most frequent driver mutations in NSCLC, accounting for 13% of patients with NSCLC (or 1 in 8).[3]

In recent years, advancements in understanding the molecular composition of KRASG12C have resulted in headway being made into the first potential targeted treatment for NSCLC and other cancers harboring this mutation. Based on this growing body of clinical data, clinicians should be encouraged to identify patients who may benefit.

The best decisions are usually made after considering all available facts. For a health care professional (HCP), making disease management and treatment decisions is no different. Identification of driver mutations via biomarker testing has increasingly shown to have led to more personalized therapeutic interventions.[4],[5] Consider a patient with breast cancer for example, who generally would not accept a treatment path before knowing if her tumor is BRCA or HER2 positive. That is because HCPs have therapeutic options to select from that can directly target a patient’s specific mutation. For people with NSCLC, biomarkers have similar significance, but there may not always be options available for their specific mutations. The potential to provide options for these patients guides the work Amgen is doing in emerging biomarkers—research that is advancing the way we understand the biology of KRASG12C and molecules that can potentially target this oncogenic protein and tumors it promotes.[6]

The high prevalence, with about 25,000 new patients being diagnosed with NSCLC in the U.S. each year that carry this mutation[7], and unmet need associated with this mutation underscore the importance of biomarker testing. KRAS G12C can be detected by various testing methods and should be considered for all patients with advanced nonsquamous NSCLC regardless of where they are in their treatment journey.[8],[9] Expanded panels or single gene tests can detect the biomarker, and both tissue and liquid biopsy samples can be utilized.8 In fact, the College of American Pathologists, the International Association for the Study of Lung Cancer, the Association for Molecular Pathology and the American Society of Clinical Oncology all recommend broad molecular profiling for certain biomarkers at diagnosis of NSCLC, including KRAS as part of an expanded panel.8,[10] With results from such tests, doctors are better able to inform their patients about their disease and develop more personalized treatment plans.

Amgen is committed to rapidly researching potentially transformative, investigational therapies for advanced nonsquamous NSCLC patients with the KRAS G12C mutation who remain in dire need of treatment options.

About the Author

Greg Friberg, MD

Vice President and Oncology Therapeutic Area Head for Global Development, Amgen

Gregory Friberg is Amgen’s Vice President and Oncology Therapeutic Area Head for Global Development. Dr. Friberg began his career at Amgen in 2006 as a Medical Director and has since held the role of Executive Medical Director and Global Product General Manager. In his current role, Dr. Friberg oversees the Hematology, Oncology and Bone Health portfolios, managing marketed products and pipeline teams as well as research and medical scientists. Prior to his work at Amgen, Dr. Friberg was an Instructor of Medicine at the University of Chicago, teaching in Hematology and Oncology.

References


[1] Ryan MB, et al. Nat Rev Clin Oncol. 2018;15:709-720.

[2] Cox AD, et al. Nat Rev Drug Discov. 2014;13:828-851.

[3] Amgen, Data on File; 2020.

[4] Kris MG, et al. JAMA. 2014;311:1998-2006.

[5] Barlesi F, et al. Lancet. 2016;387:1415-1426.

[6] Nagasaka M, et al. Cancer Treat Rev. 2020;84:101974.

[7] American Cancer Society, Cancer Facts and Figures. 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed September 3, 2020.

[8] Lindeman NI, et al. Arch Pathol Lab Med. 2018;142:321-346.

[9] Pennell N, et al. Am Soc Clin Oncol Educ Book. 2019;39:531-542.

[10] Kalemkerian GP, et al. J Clin Oncol. 2018;36:911-919.



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