Authors' objectives: Pembrolizumab (Keytruda) is a humanised monoclonal IgG4 anti-PD-1 antibody, which is very specific and has high affinity for PD-1 with pure antagonist properties. It is involved in the blockade of immune suppression and reactivation of anergic T-cells. Pembrolizumab is intended for the treatment of PD-L1 strong-positive metastatic non-small cell lung cancer (NSCLC). In phase III clinical trials it is administered intravenously (IV) at 200mg on day 1 of a 21 day cycle for up to 35 cycles or until disease progression. Approximately 85-90% of all lung cancers are of the non-small cell type. The symptoms of NSCLC include haemoptysis, malaise, significant weight loss, dyspnoea and voice loss. Smoking is the main cause of lung cancer, responsible for in excess of 80% of cases. In England there were 34,889 cases of lung cancer in 2011 (representing 46.6 cases per 100,000 population). The majority of lung cancers are diagnosed in the later stages of the disease with approximately 48% of patients presenting with metastases (stage IV). In 2013-14, there were 88,350 hospital admissions in England due to lung cancer, accounting for 108,216 finished consultant episodes and 282,717 bed days. In 2013, there were 60,848 deaths from lung cancer registered in England and Wales. In a phase Ib clinical trial of pembrolizumab for NSCLC, 60.8% of tumour samples were considered to be PD-L1 positive (percentage of neoplastic cells showing membranous staining of PD-L1 [proportion score] ≥1%), of which 38.2% had a proportion score of at least 50%. The overall prevalence of a proportion score of at least 50% was 24.9% among previously untreated patients and 22.7% among previously treated patients. A proportion score of at least 50% is associated with a higher response rate, and longer progression-free and overall survival. The aim of treatment for locally advanced or metastatic NSCLC is to prolong survival, improve quality of life, and control disease-related symptoms. Pembrolizumab is currently undergoing two phase III clinical trials assessing its effect on progression free survival and overall survival compared to platinum-based chemotherapies. Both trials are expected to be complete by July 2019.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/pembrolizumab-keytruda-for-pd-l1-strong-positive-metastatic-non-small-cell-lung-cancer-first-line/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Research&Intelligence Centre (NIHR HSRIC)