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. 2023 Oct 9;29(10):2559–2569. doi: 10.1038/s41591-023-02598-9

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© The Author(s) 2023

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

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Fig. 1 — a, The first stage of the BR.36 trial enrolled patients with advanced/metastatic NSCLC who did not harbor clinically actionable genomic alterations in EGFR or ALK and had a PD-L1 expression level of ≥1%. Patients received pembrolizumab as per local standard of care, and RECIST radiographic response assessments were performed every 6 weeks until week 12 and at longer intervals thereafter (Methods). Serial liquid biopsies were collected before treatment administration on C1D1 (baseline), C2D1 (3 weeks) and C3D1 (6 weeks), followed by ctDNA molecular response assessments at these timepoints. The primary endpoints of the trial were to determine the optimal timepoint of ctDNA molecular response and validate the concordance of ctDNA molecular response with radiographic RECIST version 1.1 response. b, BR.36 reached its target enrollment of 50 patients; for each individual, serial radiographic assessments and liquid biopsy analyses were performed. C1D1 plasma was collected for all 50 patients; C1D1 and C2D1 plasma samples were collected for 45 patients; and plasma samples were collected for all three timepoints for 39 patients. Five patients were deemed not evaluable because of missed plasma collection or non-evaluable RECIST assessments. Of the 45 evaluable patients, 10 had undetectable ctDNA at all timepoints (no tumor-specific plasma variants detected), resulting in 35 patients with evaluable ctDNA and RECIST responses.