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

Nasser K. Altorki (), Zachary H. Walsh, Johannes C. Melms, Jeffery L. Port, Benjamin E. Lee, Abu Nasar, Cathy Spinelli, Lindsay Caprio, Meri Rogava, Patricia Ho, Paul J. Christos, Ashish Saxena, Olivier Elemento, Bhavneet Bhinder, Casey Ager, Amit Dipak Amin, Nicholas J. Sanfilippo, Vivek Mittal, Alain C. Borczuk, Silvia C. Formenti, Benjamin Izar () and Timothy E. McGraw ()
Additional contact information
Nasser K. Altorki: Weill Cornell Medicine, Department of Cardiothoracic Surgery
Zachary H. Walsh: Columbia University Irving Medical Center, Vagelos College of Physicians & Surgeons
Johannes C. Melms: Columbia University Irving Medical Center, Vagelos College of Physicians & Surgeons
Jeffery L. Port: Weill Cornell Medicine, Department of Cardiothoracic Surgery
Benjamin E. Lee: Weill Cornell Medicine, Department of Cardiothoracic Surgery
Abu Nasar: Weill Cornell Medicine, Department of Cardiothoracic Surgery
Cathy Spinelli: Weill Cornell Medicine, Department of Cardiothoracic Surgery
Lindsay Caprio: Columbia University Irving Medical Center, Vagelos College of Physicians & Surgeons
Meri Rogava: Columbia University Irving Medical Center, Vagelos College of Physicians & Surgeons
Patricia Ho: Columbia University Irving Medical Center, Vagelos College of Physicians & Surgeons
Paul J. Christos: Weill Cornell Medicine
Ashish Saxena: Weill Cornell Medicine, Division of Hematology and Oncology
Olivier Elemento: Weill Cornell Medicine, Caryl and Israel Englander Institute for Precision Medicine, Institute for Computational Biomedicine, Department of Physiology and Biophysics
Bhavneet Bhinder: Weill Cornell Medicine, Caryl and Israel Englander Institute for Precision Medicine, Institute for Computational Biomedicine, Department of Physiology and Biophysics
Casey Ager: Columbia University Irving Medical Center, Vagelos College of Physicians & Surgeons
Amit Dipak Amin: Columbia University Irving Medical Center, Vagelos College of Physicians & Surgeons
Nicholas J. Sanfilippo: Weill Cornell Medicine, Department of Radiation Oncology
Vivek Mittal: Weill Cornell Medicine, Department of Cardiothoracic Surgery
Alain C. Borczuk: Department of Pathology, Northwell Health, Greenvale
Silvia C. Formenti: Weill Cornell Medicine, Department of Radiation Oncology
Benjamin Izar: Columbia University Irving Medical Center, Vagelos College of Physicians & Surgeons
Timothy E. McGraw: Weill Cornell Medicine, Department of Biochemistry

Nature Communications, 2023, vol. 14, issue 1, 1-14

Abstract: 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.

Date: 2023
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DOI: 10.1038/s41467-023-44195-x

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