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Single point of ent...
Single point of entry to the European precision cancer medicine trial network PRIME-ROSE
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- Taskén, Kjetil (författare)
- Oslo University Hospital
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- Sørum Falk, Ragnhild (författare)
- Oslo University Hospital
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- Helland, Åslaug (författare)
- Oslo University Hospital
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- Fagereng, Gro Live (författare)
- Oslo University Hospital
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- Abel, Edvard (författare)
- University of Gothenburg
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- Baltruskeviciene, Edita (författare)
- National Cancer Institute
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- Steen Carlsson, Katarina (författare)
- Swedish Institute for Health Economics
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- Jalkanen, Katriina (författare)
- Helsinki University Hospital
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- Krebs, Matthew G (författare)
- The Christie NHS Foundation Trust
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- Lassen, Ulrik (författare)
- Copenhagen University Hospital
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- Lowery, Maeve A (författare)
- Trinity College Dublin
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- Ojamaa, Kristiina (författare)
- Tartu University Hospital
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- Oliveira, Julio (författare)
- IPO Porto
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- Verlingue, Loic (författare)
- Centre Léon Bérard
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- Staal Rohrberg, Kristoffer (författare)
- Copenhagen University Hospital
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- Ryll, Bettina (författare)
- Stockholm School of Economics,Handelshögskolan i Stockholm
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- Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar (författare)
- Leiden University Medical Center
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- Voest, Emile Eugene (författare)
- The Netherlands Cancer Institute
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- Gelderblom, Hans (författare)
- Leiden University Medical Center
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- Verheul, Henk M W (författare)
- Erasmus MC Cancer Institute
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(creator_code:org_t)
- American Society of Clinical Oncology, 2024
- 2024
- Engelska.
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Ingår i: Journal of Clinical Oncology. - : American Society of Clinical Oncology. - 1527-7755 .- 0732-183X. ; 42:16
- Relaterad länk:
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https://research.hhs... (primary) (Object in context)
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https://research.hhs...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Background: Over the last decades, there has been a surge in the development and approval of targeted drugs and immunotherapies for treating cancer patients, as seen by the 757 % increase in approvals by the FDA for new cancer treatments since 2000 (1). This has significantly impacted cancer care and contributed to improving overall survival in various cancer subgroups. However, access to these new treatments is constrained by the market access strategy of the patent-owning company and available knowledge of treatment effects. Only a few treatments have received pan-cancer approval from EMA or FDA, and most drugs receive market authorization per indication. As a result, there is a widening access gap between patients with different cancer types (2). Methods: Exploring the effect of biomarker-driven treatments in new cancer subtypes requires the ability to find patients with rare biomarkers. PRIME-ROSE is a European precision medicine network comprising 11 ongoing or soon-to-start national DRUP-like clinical trials testing registered drugs outside their current label (www.prime-rose.eu). Patients with relevant tumor biomarkers are identified and treated with matched drugs available in each trial’s drug portfolio. The ambition is to swiftly and systematically evaluate the effectiveness of approved precision cancer medicines in new indications through pragmatic trial designs and with RWE control cohorts, ensuring expansion into all relevant patient groups to maximize societal benefit. This is particularly relevant for rare cancers, which are enriched in precision medicine trials (3). Results: In PRIME-ROSE, the trials now share and aggregate data to build evidence faster and more effectively impact patient care by addressing key challenges in precision cancer medicine implementation (increasing the recruitment area to 71 million inhabitants). This will significantly reduce the time for filling treatment cohorts and contribute to closing the indication/drug-specific knowledge gap. In fact, several pharmaceutical companies have already shown their interest in and commitment to participating in PRIME-ROSE, as it offers the unique advantage of entering the trials in the network simultaneously (single point of entry) and with a floating allocation of treatment slots between trials, increasing efficiency in finding patients with specific biomarkers to fill treatment cohorts. Conclusions: A unified entry point to the PRIME-ROSE network is feasible and can facilitate building the knowledge base faster for label expansion and/or country-specific approvals/ reimbursement. National multi-stakeholder ecosystems that include pragmatic, RWE-controlled DRUP-like clinical trials may advance precision medicine implementation.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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Taskén, Kjetil
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Sørum Falk, Ragn ...
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Helland, Åslaug
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Fagereng, Gro Li ...
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Abel, Edvard
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Baltruskeviciene ...
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Steen Carlsson, ...
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Jalkanen, Katrii ...
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Krebs, Matthew G
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Lassen, Ulrik
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Lowery, Maeve A
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Ojamaa, Kristiin ...
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Oliveira, Julio
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Verlingue, Loic
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Staal Rohrberg, ...
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Ryll, Bettina
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Barjesteh van Wa ...
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Voest, Emile Eug ...
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Gelderblom, Hans
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Verheul, Henk M ...
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Handelshögskolan i Stockholm