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Reply to ‘Surrogate end points in oncology: aligning drug development incentives and patient needs’

Nature Reviews Clinical Oncology volume 22, pages 619–620 (2025)Cite this article

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In a recent News & Views (Prasad, V. Surrogate end points in oncology: the speed–uncertainty trade-off from the patients’ perspective. Nat. Rev. Clin. Oncol. 22, 313–314 (2025))1, I discussed two studies that, using surveys, show that patients with cancer crave information about how long and how well they will live. That is, patients are willing to wait for overall survival (OS) results rather than accepting improvements in progression-free survival (PFS). In their Correspondence, Matthew Vogel and collaborators defend the widespread use of surrogate end points (Vogel, M. et al. Surrogate end points in oncology: aligning drug development incentives and patient needs. Nat. Rev. Clin. Oncol. https://doi.org/10.1038/s41571-025-01031-z (2025))2. I appreciate their interest in my article, although I find five problems with the points they raise.

First, Vogel et al. argue that patients “deserve the freedom to choose” and should not have policymakers limit their options. This is not a logical argument for using PFS instead of OS, but an argument against trials altogether. Why then should policymakers limit choice to drugs with a demonstrated PFS benefit? Why not also permit those showing some improvements in objective response rate? Why can’t patients receive daratumumab plus bortezomib, lenalidomide and dexamethasone (the regimen tested in the PERSEUS trial) with added teclistamab or talquetamab if they want to? We know that these agents are active. The truth is that we perform clinical trials because we need to know which regimens improve clinical outcomes, and whether they are worth the cost and toxicities. Given that societies, through healthcare systems, often pay for these drugs, knowing that this money is well spent is imperative. Moreover, patients want to know whether they will be better off with these new regimens.

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References

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Acknowledgements

V.P. receives research funding from Arnold Ventures through a grant made to the University of California, San Francisco.

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  1. Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA

    Vinay Prasad

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  1. Vinay Prasad
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Correspondence to Vinay Prasad.

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V.P. has acted as a consultant of Optum, receives royalties for books and writing from Free Press, Johns Hopkins Press and MedPage, and hosts the podcasts, Plenary Session, Sensible Medicine and VPZD, writes the newsletters the Drug Development Letter, Sensible Medicine and VP's Observations and Thoughts, and runs the YouTube channel Vinay Prasad MD MPH, which collectively earn revenue on the platforms Patreon, Substack and YouTube.

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This article was prepared when V.P. was an employee of the University of California, San Francisco, prior to his employment at the US Food and Drug Administration (FDA), and does not represent the views of the FDA.

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Prasad, V. Reply to ‘Surrogate end points in oncology: aligning drug development incentives and patient needs’. Nat Rev Clin Oncol 22, 619–620 (2025). https://doi.org/10.1038/s41571-025-01032-y

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