Receipt of subsequent immune checkpoint inhibitors at progression among patients with solid tumors enrolled in clinical trials of adjuvant immune checkpoint inhibitors
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Receipt of subsequent immune checkpoint inhibitors at progression among patients with solid tumors enrolled in clinical trials of adjuvant immune checkpoint inhibitors

Abstract

Abstract: Purpose: Immune checkpoint inhibitors can induce long-term responses in metastatic cancer, thus determining how many patients on placebo control arms of adjuvant immune checkpoint inhibitors receive these drugs as standard of care at progression is critical to assess if the benefit is truly from adjuvant administration or treatment at any point. Methods: This study included recent clinical trials of adjuvant immune checkpoint inhibitors for solid tumors that gained FDA approval. We determined the number of placebo control patients with progression events, the number who actually received subsequent immune checkpoint inhibitor, and the number who were eligible to receive it. Results: Data was available from 462 placebo control patients who experienced progression in trials of adjuvant immune checkpoint inhibitors. 377 of these control patients were eligible for first line immune checkpoint inhibitors upon progression. 34% (130/377) of eligible control patients received immune checkpoint inhibitors in the first line metastatic setting. In total, 28% (130/462) received immune checkpoint inhibitors, 54% (247/462) were eligible but did not receive it, and 18% (85/462) were ineligible according to currently accepted standard of care.Conclusions: Only 34% of eligible patients in placebo control arms of trials of adjuvant immune checkpoint inhibitors for solid tumors receive these medications upon progression. This is surprisingly low, and suggests that exposure to immune checkpoint inhibitors at all, instead of in the adjuvant setting, could explain the positive effect size of recurrence free survival observed in each of these trials.

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