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For EGFR Positive, Advanced Or Metastatic Non-Small Cell Lung Cancer – First Line

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For EGFR Positive, Advanced Or Metastatic Non-Small Cell Lung Cancer – First Line Horizon Scanning Research July 2015 & Intelligence Centre Bevacizumab (Avastin) with erlotinib (Tarceva) for EGFR positive, advanced or metastatic non-small cell lung cancer – first line SUMMARY NIHR HSRIC ID: 2920 This briefing is based on information Bevacizumab (Avastin) with erlotinib (Tarceva) is intended to be used as a first line treatment option for patients with epidermal growth factor receptor available at the time (EGFR) positive, advanced or metastatic non-small cell lung cancer of research and a (NSCLC). Bevacizumab is a humanised immunoglobulin (IgG1) monoclonal limited literature antibody that acts as a vascular endothelial growth factor antagonist and search. It is not erlotinib is an orally active inhibitor of the EGFR tyrosine kinase. intended to be a definitive statement In the UK, lung cancer is the second most common diagnosed cancer after on the safety, breast cancer, but it is the most common cause of cancer deaths, accounting efficacy or for more than 1 in 5 cancer deaths. Over 33,000 new cases of lung cancer effectiveness of the are diagnosed each year in England, 80% of these are thought to be health technology NSCLC, and 78% are anticipated to be advanced and/or metastatic at covered and should diagnosis. Approximately 15% of NSCLC is evaluated as EGFR positive. not be used for commercial European Society for Medical Oncology guidelines recommend that patients purposes or with NSCLC be tested for EGFR mutations before initiation of first line commissioning treatment. Bevacizumab and erlotinib are in phase II clinical trial, comparing without additional their effect on overall survival against treatment with erlotinib monotherapy. information. This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. NIHR Horizon Scanning Research & Intelligence Centre, University of Birmingham. Email: [email protected] Web: www.hsric.nihr.ac.uk Horizon Scanning Research & Intelligence Centre TARGET GROUP • Non-small cell lung cancer (NSCLC): advanced or metastatic; EGFR mutation positive – first line. TECHNOLOGY DESCRIPTION Bevacizumab (Avastin) is a humanised immunoglobulin (IgG1) monoclonal antibody that acts as a vascular endothelial growth factor (VEGF) antagonist. Bevacizumab binds to VEGF, the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells. Neutralising the biological activity of VEGF causes regression of the vascularisation of tumours, normalises remaining tumour vasculature and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth. Erlotinib (Tarceva) is an orally active inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. Mutations that lead to EGFR overexpression (upregulation) or over activity may lead to uncontrolled cell division and are associated with a number of cancers, including NSCLC. In phase II clinical trials, erlotinib was administered orally at 150mg daily in combination with bevacizumab administered via intravenous (IV) infusion at 15mg/kg every three weeks, both continued until disease progression or unacceptable toxicity1. Bevacizumab, in addition to platinum based chemotherapy is currently licensed for the first line treatment of adults with unresectable advanced, metastatic or recurrent NSCLC with other than predominantly squamous cell histology. It is also licensed for the treatment of colorectal carcinoma, breast cancer, renal cell cancer, cervical cancer and epithelial ovarian, fallopian tube or peritoneal cancer. Erlotinib is currently licensed for the first line treatment of patients with locally advanced or NSCLC with EGFR activating mutations; for the maintenance treatment of patients with locally advanced or metastatic NSCLC with EGFR activating mutations; and for the maintenance treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. It is also licensed for the treatment of pancreatic cancer. Bevacizumab is currently in phase III trials for breast cancer, glioblastoma, head and neck cancer, ovarian cancer and renal cancer. Erlotinib is also in phase III trials for ependymoma in children and for head and neck cancer. INNOVATION and/or ADVANTAGES If licensed, bevacizumab with erlotinib will offer an additional treatment option for patients with advanced EGFR positive NSCLC. DEVELOPER Roche Products Ltd. AVAILABILITY, LAUNCH OR MARKETING In phase III clinical trials 2 Horizon Scanning Research & Intelligence Centre PATIENT GROUP BACKGROUND Approximately 85-90% of all lung cancers are of the non-small cell type; NSCLC can be further classified into three histological sub-types, namely large-cell undifferentiated carcinoma, squamous cell carcinoma, and adenocarcinoma2. The symptoms of NSCLC include haemoptysis, malaise, significant weight loss, dyspnoea and voice loss3. Smoking is the main cause of lung cancer, responsible for in excess of 80% of cases; other known risk factors include exposure to asbestos, arsenic, radon, and non-tobacco-related polycyclic aromatic hydrocarbons4. NHS or GOVERNMENT PRIORITY AREA This topic is relevant to: • Improving Outcomes: A Strategy for Cancer (2011). • NHS England. 2013/14 NHS Standard Contract for Cancer: Chemotherapy (Adult). B15/S/a. • NHS England. 2013/14 NHS Standard Contract for Cancer: Radiotherapy (All Ages). B01/S/a. CLINICAL NEED and BURDEN OF DISEASE In the UK, lung cancer is the second most common diagnosed cancer after breast cancer, but it is the most common cause of cancer death, accounting for more than 1 in 5 cancer deaths5. In England there were 34,889 cases of lung cancer in 2011 (representing 46.6 cases per 100,000 population) (ICD-10 C33-C34)6. Incidence of lung cancer is higher in lower socioeconomic groups, and survival is poorer in these groups compared to higher socioeconomic groups7. The majority of lung cancers are diagnosed in the later stages of the disease, with 21% presenting with locally and regionally advanced disease (stage IIIB) and 48% presenting with metastases (stage IV)2. For people presenting with NSCLC stage IIIB disease, the 5-year survival rate is around 7 to 9%; for people presenting with NSCLC stage IV the 5-year survival rate varies from 2 to 13%2. Median survival for patients with stage IV disease NSCLC treated with platinum-based therapy is 8 to 12 months8,9. Over 33,000 new diagnoses of lung cancer are made each year in England10. Of these, 80% are thought to be NSCLC and 78% are anticipated to be advanced and/or metastatic at diagnosis2. Approximately 15% of NSCLC is evaluated as EGFR positive10. Expert personal communication suggests that the average survival for patients with EGFR positive tumours is 2-3 yearsa. In 2013-14, there were 88,350 hospital admissions in England due to lung cancer (ICD-10 C34), accounting for 108,216 finished consultant episodes and 282,717 bed days11. In 2013, there were 60,848 deaths from lung cancer registered in England and Wales12. a Expert personal communication. 3 Horizon Scanning Research & Intelligence Centre PATIENT PATHWAY RELEVANT GUIDANCE NICE Guidance • NICE technology appraisal in development. Erlotinib and gefitinib for the treatment of non-small cell lung cancer that has progressed following prior chemotherapy (review of TA162 and TA175) (ID620). Expected date of issue to be confirmed. • NICE technology appraisal in development. Ceritinib for previously treated anaplastic lymphoma kinase-positive non-small cell lung cancer (ID729). Expected January 2016. • NICE technology appraisal in development. Nintedanib for treating previously treated metastatic non-small cell lung cancer (ID438). Expected July 2015. • NICE technology appraisal. Pemetrexed for maintenance treatment following induction therapy with pemetrexed and cisplatin for non-squamous non-small cell lung cancer (TA309). April 2014. • NICE technology appraisal. Afatinib for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small cell lung cancer (TA310). April 2014. • NICE technology appraisal. Crizotinib for previously treated non-small cell lung cancer associated with an anaplastic lymphoma kinase fusion gene (TA296). September 2013. • NICE technology appraisal. Erlotinib for the first-line treatment of locally advanced or metastatic EGFR-TK mutation-positive non-small cell lung cancer (TA258). June 2012. • NICE technology appraisal. Erlotinib monotherapy for maintenance treatment of non- small cell lung cancer (TA227). June 2011. • NICE technology appraisal. Gefitinib for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (TA192). July 2010. • NICE technology appraisal. Pemetrexed for the maintenance treatment of non-small cell lung cancer (TA190). June 2010. • NICE technology appraisal. Pemetrexed for the first-line treatment of non-small cell lung cancer (TA181). September 2009. • NICE technology appraisal. Erlotinib for the treatment of non-small cell lung cancer (TA162). November 2008. • NICE technology appraisal. Pemetrexed for the treatment of non-small cell lung cancer (TA124). August 2007. • NICE clinical guideline. Lung cancer: the diagnosis and treatment of lung cancer (CG121). April 2011. • NICE quality standard. Quality standard for lung cancer (QS17). March 2012. Other Guidance
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