@article{eb8297449a5f4d8e84388061a0c6eec4,
title = "Neoadjuvant durvalumab plus radiation versus durvalumab alone in stages I–III non-small cell lung cancer: survival outcomes and molecular correlates of a randomized phase II trial",
abstract = "We previously reported the results of a randomized phase II trial (NCT02904954) in patients with early-stage non-small cell lung cancer (NSCLC) who were treated with either two preoperative cycles of the anti-PD-L1 antibody durvalumab alone or combined with immunomodulatory doses of stereotactic radiation (DRT). The trial met its primary endpoint of major pathological response, which was significantly higher following DRT with no new safety signals. Here, we report on the prespecified secondary endpoint of disease-free survival (DFS) regardless of treatment assignment and the prespecified exploratory analysis of DFS in each arm of the trial. DFS at 2 and 3 years across patients in both arms of the trial were 73% (95% CI: 62.1–84.5) and 65% (95% CI: 52.5–76.9) respectively. For the exploratory endpoint of DFS in each arm of the trial, three-year DFS was 63% (95% CI: 46.0–80.4) in the durvalumab monotherapy arm compared to 67% (95% CI: 49.6–83.4) in the dual therapy arm. In addition, we report post hoc exploratory analysis of progression-free survival as well as molecular correlates of response and recurrence through high-plex immunophenotyping of sequentially collected peripheral blood and gene expression profiles from resected tumors in both treatment arms. Together, our results contribute to the evolving landscape of neoadjuvant treatment regimens for NSCLC and identify easily measurable potential biomarkers of response and recurrence.",
author = "Altorki, {Nasser K.} and Walsh, {Zachary H.} and Melms, {Johannes C.} and Port, {Jeffery L.} and Lee, {Benjamin E.} and Abu Nasar and Cathy Spinelli and Lindsay Caprio and Meri Rogava and Patricia Ho and Christos, {Paul J.} and Ashish Saxena and Olivier Elemento and Bhavneet Bhinder and Casey Ager and Amin, {Amit Dipak} and Sanfilippo, {Nicholas J.} and Vivek Mittal and Borczuk, {Alain C.} and Formenti, {Sylvia C.} and Benjamin Izar and McGraw, {Timothy E.}",
note = "Funding Information: This trial was funded by AstraZeneca, which provided durvalumab. The first author (N.K.A.) had full access to all the data in the study and had final responsibility for the decision to submit for publication. The funding source had no role in study design, conduct, data collection, data analysis or the writing of this report. Correlative studies were funded by the Neuberger Berman Lung Cancer Research Center of Weill Cornell Medicine. Generous support was also provided by the Yoram Cohen and Family research fund, the Victoria Moran-Furman and Jay Furman research fund, and the Patricia Donnington research fund. N.K.A., O.E., V.M., A.C.B. and T.E.M. are supported in part by 5UH3CA244697. N.K.A. and T.E.M. are supported in part by Department of Defense grant W81XWH2110309. N.K.A. and V.M. are supported in part by National Cancer Institute grant 1 R01 CA271545-01A1. B.I. is supported by National Institute of Health grants, R37CA258829, R01CA280414, R01CA266446, U54CA274506, and additional by the Pershing Square Sohn Cancer Research Alliance Award, the Burroughs Wellcome Fund Career Award for Medical Scientists; a Tara Miller Melanoma Research Alliance Young Investigator Award; the Louis V. Gerstner, Jr. Scholars Program; and the V Foundation Scholars Award. Publisher Copyright: {\textcopyright} 2023, The Author(s).",
year = "2023",
month = dec,
doi = "10.1038/s41467-023-44195-x",
language = "English (US)",
volume = "14",
journal = "Nature Communications",
issn = "2041-1723",
publisher = "Nature Publishing Group",
number = "1",
}