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dc.contributor.authorQuinn, C
dc.contributor.authorGarrison, LP
dc.contributor.authorPownell, AK
dc.contributor.authorAtkins, MB
dc.contributor.authorde Pouvourville, G
dc.contributor.authorHarrington, K
dc.contributor.authorAscierto, PA
dc.contributor.authorMcEwan, P
dc.contributor.authorWagner, S
dc.contributor.authorBorrill, J
dc.contributor.authorWu, E
dc.identifier.citationJournal for immunotherapy of cancer, 2020, 8 (2)en_US
dc.description.abstractImmuno-oncologics (IOs) differ from chemotherapies as they prime the patient's immune system to attack the tumor, rather than directly destroying cancer cells. The IO mechanism of action leads to durable responses and prolonged survival in some patients. However, providing robust evidence of the long-term benefits of IOs at health technology assessment (HTA) submission presents several challenges for manufacturers. The aim of this article was to identify, analyze, categorize, and further explore the key challenges that regulators, HTA agencies, and payers commonly encounter when assessing the long-term benefits of IO therapies. Insights were obtained from an international, multi-stakeholder steering committee (SC) and expert panels comprising of payers, economists, and clinicians. The selected individuals were tasked with developing a summary of challenges specific to IOs in demonstrating their long-term benefits at HTA submission. The SC and expert panels agreed that standard methods used to assess the long-term benefit of anticancer drugs may have limitations for IO therapies. Three key areas of challenges were identified: (1) lack of a disease model that fully captures the mechanism of action and subsequent patient responses; (2) estimation of longer-term outcomes, including a lack of agreement on ideal methods of survival analyses and extrapolation of survival curves; and (3) data limitations at the time of HTA submission, for which surrogate survival end points and real-world evidence could prove useful. A summary of the key challenges facing manufacturers when submitting evidence at HTA submission was developed, along with further recommendations for manufacturers in what evidence to produce. Despite almost a decade of use, there remain significant challenges around how best to demonstrate the long-term benefit of checkpoint inhibitor-based IOs to HTA agencies, clinicians, and payers. Manufacturers can potentially meet or mitigate these challenges with a focus on strengthening survival analysis methodology. Approaches to doing this include identifying reliable biomarkers, intermediate and surrogate end points, and the use of real-world data to inform and validate long-term survival projections. Wider education across all stakeholders-manufacturers, payers, and clinicians-in considering the long-term survival benefit with IOs is also important.en_US
dc.titleCurrent challenges for assessing the long-term clinical benefit of cancer immunotherapy: a multi-stakeholder perspective.en_US
dc.typeJournal Article
dc.relation.isPartOfJournal for immunotherapy of canceren_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Biology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy
pubs.embargo.termsNot knownen_US
icr.researchteamTargeted Therapy
dc.contributor.icrauthorHarrington, Kevinen_US

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