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Molecularly Driven Management and Maintenance Treatment of NSCLC: Physician and Payer Perspectives on the Changing Treatment Paradigms in Europe
Decision Resources, Inc, October 2011, Pages: 170
Treatment paradigms for non-small-cell lung cancer (NSCLC) in Europe are undergoing significant changes as the molecular pathogenesis of disease is further elucidated, and researchers continue to make considerable advances in the use of novel therapeutic strategies. In particular, treatment of advanced disease is increasingly influenced by tumor molecular characteristics predictive of response to certain targeted agents.
Painstaking retrospective and prospective analyses of clinical trial data on endothelial growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) led to European approval in 2010 for AstraZeneca’s Iressa across all lines of therapy in patients harboring an activating EGFR mutation—seven years after its original filing for use in the wider NSCLC population—while Roche/OSI’s Tarceva was approved in August 2011 for the first-line treatment of patients with mutant EGFR. Several agents in late-stage development for NSCLC also demonstrate effective targeting on the basis of molecular markers and are expected to enter the market over the next few years.
Most notably, Pfizer’s first-in-class crizotinib, a TKI targeting anaplastic lymphoma kinase (ALK) and hepatocyte growth factor receptor tyrosine kinase (HGFR)/human mesenchymal-epithelial transition factor (c-MET) has proven extremely efficacious in the small population of NSCLC patients who express the echinoderm microtubule-associated protein-like 4 (EML4)-anaplastic lymphoma kinase (ALK) fusion protein. This agent launched in the United States in August 2011 (as Xalkori) and was filed with the European Medicines Agency the same month. In addition, promising early clinical data on irreversible EGFR inhibitors Tomtovok (afatinib; Boehringer-Ingelheim) and dacomitinib (PF-00299804; Pfizer) and c-Met inhibitors tivantinib (ARQ-197; ArQule/Daiichi Sankyo/Kyowa Hakko Kirin) and MetMab (onartuzumab; Genentech) have also aroused interest.
An equally intriguing treatment strategy is maintenance therapy, which is undoubtedly gaining traction in all markets, including the EU5. In an effort to delay disease progression and/or to extend overall survival in patients with advanced NSCLC, continuation or switch maintenance treatment may be prescribed. Maintenance treatments include chemotherapeutics as well as targeted agents.
Eli Lilly’s Alimta, a folate antimetabolite, received approval as switch maintenance therapy in Europe in 2009 for patients with nonsquamous cell tumors and Tarceva also got the nod the following year. In October 2011, Alimta was approved in Europe for use as continuation maintenance treatment, while the standard treatment protocol for the vascular endothelial growth factor (VEGF) monoclonal antibody Avastin (Genentech/Roche/Chugai) also involves continuation maintenance treatment.
Abbreviations Used in This Report Slides 2-4
Executive Summary Slides 5-23
Commercial Context Slides 24-43
Methodology Slides 44-47
Overview and Analysis of Reimbursement in the EU5 Slides 48-85
Analysis of Survey Results Slides 86-125
European Healthcare Briefing Slides 126-168
About the Author Slide 169
For Further Information Slide 170