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Tarlatamab in small-cell lung cancer after platinum-based chemotherapy

Mountzios, G.
; 
Sun, L.
; 
Cho, B. C.
; 
Demirci, U.
; 
Baka, S.
; 
Gümüş, M.
; 
Lugini, A.
; 
Zhu, B.
; 
Yu, Y.
; 
Korantzis, I.
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Abstract
BACKGROUND: Tarlatamab, a bispecific delta-like ligand 3-directed T-cell engager immunotherapy, received accelerated approval for the treatment of patients with previously treated small-cell lung cancer. Whether tarlatamab is more effective than chemotherapy in the treatment of patients whose small-cell lung cancer has progressed during or after initial platinum-based chemotherapy is not known. METHODS: We conducted a multinational, phase 3, open-label trial to compare tarlatamab with chemotherapy as second-line treatment in patients with small-cell lung cancer whose disease had progressed during or after platinum-based chemotherapy. Patients were randomly assigned to receive tarlatamab or chemotherapy (topotecan, lurbinectedin, or amrubicin). The primary end point was overall survival. Key secondary end points were investigator-assessed progression-free survival and patient-reported outcomes. Results of the prespecified interim analysis (data-cutoff date, January 29, 2025) are reported. RESULTS: A total of 509 patients were randomly assigned to receive tarlatamab (254 patients) or chemotherapy (255 patients). Treatment with tarlatamab resulted in significantly longer overall survival than chemotherapy (median, 13.6 months [95% confidence interval {CI}, 11.1 to not reached] vs. 8.3 months [95% CI, 7.0 to 10.2]; stratified hazard ratio for death, 0.60; 95% CI, 0.47 to 0.77; P<0.001). Tarlatamab treatment also had a significant benefit with respect to progression-free survival and cancer-related dyspnea and cough as compared with chemotherapy. The incidence of adverse events of grade 3 or higher was lower with tarlatamab than with chemotherapy (54% vs. 80%), as was the incidence of adverse events resulting in treatment discontinuation (5% vs. 12%). CONCLUSIONS: Treatment with tarlatamab led to longer overall survival than chemotherapy among patients with small-cell lung cancer whose disease had progressed during or after platinum-based chemotherapy. (Funded by Amgen; DeLLphi-304 ClinicalTrials.gov number, NCT05740566.).
Authors
Mountzios, G.
Sun, L.
Cho, B. C.
Demirci, U.
Baka, S.
Gümüş, M.
Lugini, A.
Zhu, B.
Yu, Y.
Korantzis, I.
Han, J. Y.
Ciuleanu, T. E.
Ahn, M. J.
Rocha, P.
Mazières, J.
Lau, S. C. M.
Schuler, M.
Blackhall, F.
Yoshida, T.
Owonikoko, T. K.
Paz-Ares, L.
Jiang, T.
Hamidi, A.
Gauto, D.
Recondo, G.
Rudin, C. M.
Affiliation
Fourth Department of Medical Oncology and Clinical Trials Unit, Henry Dunant Hospital Center, Athens. Department of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea. Department of Medical Oncology, Memorial Ankara Hospital, Ankara, Turkey. European Interbalkan Medical Center, Thessaloniki, Greece. Istanbul Medeniyet University, Istanbul, Turkey. Medical Oncology Unit, Azienda Ospedaliera San Giovanni Addolorata Hospital, Rome. Second Affiliated Hospital of Army Medical University, Chongqing, China. Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, China. Department of Medical Oncology, St. Luke's Hospital, Thessaloniki, Greece. Center for Lung Cancer, National Cancer Center, Goyang, South Korea. Institute of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca, Cluj-Napoca, Romania. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Department of Medical Oncology Service, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona. Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France. Department of Medical Oncology, NYU Langone Health Perlmutter Cancer Center, New York. Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany. National Center for Tumor Diseases West, Essen, Germany. Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom. Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo. University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore. Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid. Amgen, Thousand Oaks, CA. Fiona and Stanley Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center, New York.
Description
Date
2025
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All Christie Publications
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Article
Citation
Mountzios G, Sun L, Cho BC, Demirci U, Baka S, Gümüş M, et al. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. The New England journal of medicine. 2025 Jul 24;393(4):349-61. PubMed PMID: 40454646. Epub 2025/06/02. eng.
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https://christie.openrepository.com/handle/10541/628143
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