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Keytruda® approved by EC for specific population of patients with advanced NSCLC

MSD has announced that the European Commission (EC) has granted marketing authorisation for its immunotherapy treatment Keytruda (pembrolizumab) as a monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express programmed death ligand-1 (PD-L1) and who have had at least one prior chemotherapy regimen.1

Those patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumours should also have received approved therapy for those mutations for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express programmed death ligand-1 (PD-L1) and who have received at least one prior chemotherapy regimen. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) tumour mutations should also have received approved therapy for these mutations prior to receiving pembrolizumab.

Lung cancer is one of the most common forms of cancer, with more than 45,000 new cases diagnosed in 2013.2 The five-year survival rate of patients with lung cancer is below 20% everywhere in Europe.3

Professor Dean Fennell, Chair of Thoracic Medical Oncology, University of Leicester said: “This is really good news for people with lung cancer, who are often diagnosed at a late stage and have had very few treatment options up to now. Changing outcomes for patients that have late stage lung cancer is one of the biggest challenges right now in cancer treatment. There is currently high demand for new NSCLC therapies that improve survival without greatly increasing the toxicity or significantly compromising the quality of life of patients”

Professor John Gosney, Consultant Thoracic Pathologist, Royal Liverpool University Hospital added: “Immune modulating drugs such as pembrolizumab are a huge step forward in the treatment of advanced NSCLC. All lung cancers are not the same, however, and the rational and effective use of such therapies has to be guided by detailed characterisation of tumour tissue. Seeking ‘biomarkers’ such as PD-L1 in such tissue is extremely important. It predicts not only how effective different drugs are likely to be, allowing management to be precisely tailored to the needs of the individual, but allows them to be used in the most appropriate and cost-effective way.”

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The EC decision was based on data from the phase II/III open-label, randomised, international KEYNOTE-010 clinical study. This study recruited patients with previously-treated advanced NSCLC whose tumours expressed PD-L1. The study demonstrated that pembrolizumab improved overall survival (OS) in the total study population (any level of PD-L1 expression) compared with docetaxel, a standard of care chemotherapy for patients with previously-treated advanced NSCLC.4

Pembrolizumab for the treatment of previously treated advanced NSCLC patients whose tumours express PD-L1 is currently under review by NICE.

Mike Nally, UK Managing Director, MSD said; “MSD is delighted that the EC has recognised the potential of pembrolizumab in this second therapy area of lung cancer, following the approval for the treatment of melanoma in 2015. This approval provides a new therapy option in the management of lung cancer, giving eligible patients increased hope for the future.”

Pembrolizumab is one of a new generation of immunotherapies that works by making the cancer cell ‘visible’ to the immune system so it can be attacked by the body’s natural defence mechanisms5 and was first licensed in 2015 in the EU as a monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults.1

The licensed dose of pembrolizumab is 2mg/kg administered over a 30-minute infusion every three weeks.


  1.  Keytruda SmPC. Last accessed August 2016   
  3. Allemani C et al. Global surveillance of cancer survival 1995–2009: analysis of individual data for 25 676 887 patients from 279 population-based registries in 67 countries (CONCORD-2) The Lancet. Vol 385 March 2015. p977–1010
  4. Herbst R, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. Vol 387 April 09, 2016. P. 1540 – 1550
  5. Robert, C, Ribas, A, Wolchok, J, et al: Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. The Lancet. Vol 384 September 20, 2014. P. 1109 – 1117.