Masterarbeit

Innovative Immunotherapy in Oncology - PD-1 / PD-L1 Inhibitors in Treatment of Non-Small Cell Lung Cancer (NSCLC) and its Regulatory Aspects

Lena Chugunow (2019)

Summary
Language: English
Despite the recent development of many innovative therapies, lung cancer is still a largely intractable disease with a poor prognosis, causing 1.69 million tumor-related deaths annually worldwide (WHO, 2018). The high mortality rate proves the need for better treatments. Approximately 85% of all lung cancers are non-small cell lung cancers (NSCLC), one of the most genomically diverse of all cancers, which creates tremendous challenges for both prevention and treatment strategies.
The 2018 Nobel Prize in Physiology or Medicine awarded James P. Allison and Tasuku Honjo "for their discovery of cancer therapy by inhibition of negative immune regulation" highlights a milestone in the therapeutic approach to cancer treatment. This pioneering research on PD-1 ("programmed cell death protein-1") and PD-L1 ("programmed cell death-ligand 1") encouraged the development of immune checkpoint inhibitors, marking the beginning of the new era of cancer immunotherapy. Due to their promising results, several monotherapies as well as combination therapies with immunotherapeutics have already received marketing authorisation from the European Medicines Agency and are now changing the therapeutic landscape. Innovative immunotherapy provides insights into the progress of personalised medicine which goes hand in hand with new challenges regulators, medicine developers and health technology assessment (HTA) bodies have to face. The integration of molecular testing results is an essential component of clinical decision making in NSCLC.
To prepare for the future, there is a need for long-term data and innovative access strategies to meet the regulatory requirements, to support rapid reimbursement, to adopt biomarker tests in clinical practice as well as to address new challenges evolving with further developments in the field of immunotherapy. To conclude, only a holistic, multi-faceted approach to immunotherapy, involving perspectives of different decision makers, can ensure the attractiveness of the development and launching of innovative oncology medicines.
Pages: 54, Annexes: 3