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Perspectives on the integration of immuno-oncology biomarkers and drugs in a health care setting

(2018) SEMINARS IN CANCER BIOLOGY. 52. p.166-177
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Abstract
Immunotherapies, specifically checkpoint inhibitors, are becoming an important component in cancer care with the most application now in melanoma and lung cancer patients. Some drawbacks that converge with this new evolution are the rather low response rates to these drugs and their high cost with a significant economic impact on the health care system. These major challenges can likely be circumvented by implementing a "personalized immuno-oncology" approach to accomplish a selection of optimal responders based on biomarkers. In this paper we first discuss the legal framework for the development of valuable in vitro diagnostics. Based on a case study in lung cancer, the clinical validity and utility requirements of predictive immuno-oncology biomarkers is highlighted and an overview is given on the evolution towards multiplex or omics-based assays together with its challenges and pitfalls. Finally, some initiatives between the public and private sector are pinpointed to sustain the future access to innovative medicines in cancer therapy at a reasonable cost.
Keywords
Biomarker, Immunotherapy, Cancer, Validation, Regulatory, CELL LUNG-CANCER, TUMOR-INFILTRATING LYMPHOCYTES, RANDOMIZED CONTROLLED-TRIAL, PD-1 BLOCKADE, CLINICAL IMMUNOHISTOCHEMISTRY, PRECISION MEDICINE, QUALITY-ASSURANCE, COMPANION DIAGNOSTICS, ANTI-PD-L1

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Citation

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Chicago
Vermaelen, Karim, A Waeytens, O Kholmanskikh, M Van den Bulcke, and E Van Valckenborgh. 2018. “Perspectives on the Integration of Immuno-oncology Biomarkers and Drugs in a Health Care Setting.” Seminars in Cancer Biology 52: 166–177.
APA
Vermaelen, K., Waeytens, A., Kholmanskikh, O., Van den Bulcke, M., & Van Valckenborgh, E. (2018). Perspectives on the integration of immuno-oncology biomarkers and drugs in a health care setting. SEMINARS IN CANCER BIOLOGY, 52, 166–177.
Vancouver
1.
Vermaelen K, Waeytens A, Kholmanskikh O, Van den Bulcke M, Van Valckenborgh E. Perspectives on the integration of immuno-oncology biomarkers and drugs in a health care setting. SEMINARS IN CANCER BIOLOGY. 2018;52:166–77.
MLA
Vermaelen, Karim, A Waeytens, O Kholmanskikh, et al. “Perspectives on the Integration of Immuno-oncology Biomarkers and Drugs in a Health Care Setting.” SEMINARS IN CANCER BIOLOGY 52 (2018): 166–177. Print.
@article{8575314,
  abstract     = {Immunotherapies, specifically checkpoint inhibitors, are becoming an important component in cancer care with the most application now in melanoma and lung cancer patients. Some drawbacks that converge with this new evolution are the rather low response rates to these drugs and their high cost with a significant economic impact on the health care system. These major challenges can likely be circumvented by implementing a "personalized immuno-oncology" approach to accomplish a selection of optimal responders based on biomarkers. In this paper we first discuss the legal framework for the development of valuable in vitro diagnostics. Based on a case study in lung cancer, the clinical validity and utility requirements of predictive immuno-oncology biomarkers is highlighted and an overview is given on the evolution towards multiplex or omics-based assays together with its challenges and pitfalls. Finally, some initiatives between the public and private sector are pinpointed to sustain the future access to innovative medicines in cancer therapy at a reasonable cost.},
  author       = {Vermaelen, Karim and Waeytens, A and Kholmanskikh, O and Van den Bulcke, M and Van Valckenborgh, E},
  issn         = {1044-579X},
  journal      = {SEMINARS IN CANCER BIOLOGY},
  keywords     = {Biomarker,Immunotherapy,Cancer,Validation,Regulatory,CELL LUNG-CANCER,TUMOR-INFILTRATING LYMPHOCYTES,RANDOMIZED CONTROLLED-TRIAL,PD-1 BLOCKADE,CLINICAL IMMUNOHISTOCHEMISTRY,PRECISION MEDICINE,QUALITY-ASSURANCE,COMPANION DIAGNOSTICS,ANTI-PD-L1},
  language     = {eng},
  pages        = {166--177},
  title        = {Perspectives on the integration of immuno-oncology biomarkers and drugs in a health care setting},
  url          = {http://dx.doi.org/10.1016/j.semcancer.2017.11.011},
  volume       = {52},
  year         = {2018},
}

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