UK Medicines and Healthcare Products Regulatory Agency (MHRA) issues a conditional Marketing Authorisation of TEPMETKO® (tepotinib) for the treatment of advanced NSCLC with METex14 Skipping Alterations
Merck announces that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a conditional Marketing Authorisation (CMA) 1 in Great Britain for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.2
This authorisation is based on results from the Phase II VISION study evaluating tepotinib as monotherapy in patient with advanced or metastatic NSCLC with METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy. Efficacy was evaluated in 146 patients and the study demonstrated an objective response rate, the primary outcome measure, by independent review of 45.2% (95% confidence interval [CI], 37.0 to 53.6) in the combined-biopsy group. 2 Data from the primary analysis of the VISION study were published in The New England Journal of Medicine (NEJM) on 29 May 2020.3
Lung cancer is the third most common cancer in the UK, with over 47,000 people diagnosed every year (2015-2017), and was the leading cause of cancer related death in the UK in 2018. 4,5 NSCLC is the most common type of lung cancer and accounts for approximately 80-85% of all lung cancer diagnoses in the UK.6 METex14 alterations occur in approximately 3-4% of NSCLC cases and generally exhibit a poorer clinical prognosis compared with other types of NSCLC.7
“We welcome the decision by the MHRA to authorise the targeted therapy, tepotinib. Lung cancer can be an aggressive, hard-to-treat cancer so it is vital we have as many treatment options available to patients so they can live well with this disease for as long as possible. This decision takes us a step closer to having another treatment for people in this country who are living with non-small cell lung cancer,” said Paula Chadwick, Chief Executive, Roy Castle Lung Cancer Foundation.
“This is the first MHRA authorised MET inhibitor to be made available to eligible patients, and as such would have a significant impact on their current clinical outcomes. This authorisation is an important advancement for patients with METexon14 skipping aberrations and represents a significant step forward in the development of new targeted therapies in advanced NSCLC,” said Professor Sanjay Popat, Consultant Thoracic Medical Oncologist, The Royal Marsden NHS Foundation Trust.
Dr Stuart Hill, Medical Director, Merck UK & Ireland said: “Merck is delighted to have received MHRA authorisation for tepotinib, a novel MET targeted oral therapy for adult patients with advanced non-small cell lung cancer. Tepotinib targets rare MET exon 14 skipping mutations and is the first therapy of this kind to be granted a GB marketing authorisation. This authorisation means that eligible patients, who typically have a poor prognosis, now have an additional treatment option available to them.”
Tepotinib has been authorised under a ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited. The authorisation was conducted through Project ORBIS, which is coordinated by the US Food and Drug Administration (FDA), which reviews and approves promising cancer treatments concurrently with regulatory authorities in six other countries, including the UK’s MHRA. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies across the globe. Applications submitted to the MHRA within a Project Orbis procedure are national (Great Britain only) marketing authorisation applications and variations. 8