Strategic risk assessment in oncology: Utilizing single-agent activity to boost combination therapy approvals

The likelihood of approval for combination therapies is higher when combined with monotherapy drugs that have previously shown single agent activity. This finding is consistent with other research on historical approval rates and the common consensus within oncology drug development. Here we suggest that by leveraging monotherapy drug activity there can be an enhanced prioritization of anti-cancer agents repurposed for combination therapies, which would have otherwise been shelved based on their single agent failure.

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Publication Details

Journal
Contemporary Clinical Trials Communications
Published
2025-12-31
DOI
https://doi.org/10.1016/j.conctc.2025.101590
Primary Topic
Advanced Causal Inference Techniques
Type
article
Field-Weighted Citation Impact
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article

Strategic risk assessment in oncology: Utilizing single-agent activity to boost combination therapy approvals

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Contemporary Clinical Trials Communications
Advanced Causal Inference Techniques
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Strategic risk assessment in oncology: Utilizing single-agent activity to boost combination therapy approvals

Maria Georganaki, Paul K. Stockman, Adetayo Kasim, Andreas Dimakakos, Dimitris Skaltas, Evangelia Loizou, Ioannis Mourelatos, Panos Karelis, Marianna Esposito, Marina Anastasiou, Tai-Tsang Chen, Helen Zhou
article en

Abstract

The likelihood of approval for combination therapies is higher when combined with monotherapy drugs that have previously shown single agent activity. This finding is consistent with other research on historical approval rates and the common consensus within oncology drug development. Here we suggest that by leveraging monotherapy drug activity there can be an enhanced prioritization of anti-cancer agents repurposed for combination therapies, which would have otherwise been shelved based on their single agent failure.

Contemporary Clinical Trials CommunicationsVol. 49
GlaxoSmithKline (United Kingdom) (GB), Age UK (GB), GlaxoSmithKline (United States) (US), RGenix (United States) (US)
Good health and well-being
Openalex Percentile: Top 22%
Advanced Causal Inference Techniques
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