The FDA approval of perioperative pembrolizumab, an approach that combines neoadjuvant and adjuvant therapy with this agent, for patients with early stage non-small-cell lung cancer (NSCLC) contradicts its own stated standard for combination therapies. Given the large population of patients with early stage NSCLC and the high costs of pembrolizumab, whether the adjuvant component provides incremental benefit is an important question.
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References
US Food and Drug Administration. FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer. fda.gov, https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-adjuvant-pembrolizumab-resectable-non-small-cell-lung-cancer (2023).
US Food and Drug Administration. FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer. fda.gov, https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-nivolumab-and-platinum-doublet-chemotherapy-early-stage-non-small-cell-lung (2022).
Strohbehn, G. W., Kacew, A. J., Goldstein, D. A., Feldman, R. C. & Ratain, M. J. Combination therapy patents: a new front in evergreening. Nat. Biotechnol. 39, 1504–1510 (2021).
Theoret, M. Selected regulatory considerations for cancer immunotherapeutic combinations: contribution of individual components to effect of combination. nationalacademies.org, https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/DB9638AC5DA89CA34A0EF877A87AFF4EFFE659FF9F3C?noSaveAs=1 (accessed 14 December 2023).
Eun, Y. et al. Risk factors for immune-related adverse events associated with anti-PD-1 pembrolizumab. Sci. Rep. 9, 14039 (2019).
US Food and Drug Administration. FDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancer. fda.gov, https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-adjuvant-treatment-non-small-cell-lung-cancer (2023).
Forde, P. M. et al. Neoadjuvant nivolumab plus chemotherapy in resectable lung cancer. N. Engl. J. Med. 386, 1973–1985 (2022).
Wakelee, H. et al. Perioperative pembrolizumab for early-stage non–small-cell lung cancer. N. Engl. J. Med. 389, 491–503 (2023).
Centers for Medicare and Medicaid Services. Medicare Part B Drug Spending Dashboard. cms.gov, https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/information-on-prescription-drugs/medicarepartb (2020).
Strohbehn, G. W., Lichter, A. S. & Ratain, M. J. US government payer-funded trials to address oncology’s drug-dosing conundrum: a congressional call to action? J. Clin. Oncol. 41, 2488–2492 (2023).
Acknowledgements
G.W.S. is an employee of the US Department of Veterans Affairs; the opinions expressed herein are the authors’ and do not necessarily reflect those of the US Government. The authors would like to acknowledge H. J. West of Summit Therapeutics for helpful and engaging discussions on this topic. B.G. receives salary support from Ontario Institute for Cancer Research, funded by the Government of Ontario; the opinions expressed herein are the authors’ and do not necessarily reflect those of the Government of Ontario.
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G.W.S. has acted as a consultant of EBSCO Information Systems and VIVIO Health and is listed as an inventor/co-inventor on patents related to dose optimization technologies and is the director of the Optimal Cancer Care Alliance, an Ann Arbor, MI, USA-based 501(c)3 non-profit organization. B.G. has acted as a consultant of VIVIO Health.
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Strohbehn, G.W., Gyawali, B. ‘Contribution of component’ and the perioperative immune-checkpoint inhibitor precedent. Nat Rev Clin Oncol 21, 249–250 (2024). https://doi.org/10.1038/s41571-023-00857-9
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DOI: https://doi.org/10.1038/s41571-023-00857-9