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Peer-reviewedCC BYAnnals of oncology : official journal of the European Society for Medical Oncology

Extended follow-up of tarlatamab in patients with small-cell lung cancer after platinum-based chemotherapy in the randomized phase 3 DeLLphi-304 study

  • C.M. Rudin1
  • M-J. Ahn2
  • M. Schuler3,4
  • F.H. Blackhall5
  • G. Mountzios6
  • T. Yoshida7
  • L. Sun8
  • B.C. Cho9
  • A. Lugini10
  • S. Arulananda11
  • S.R. Punekar12
  • P. Rocha13
8 more authors
  • L. Paz-Ares14
  • J. Mazières15
  • M. Gümüş16
  • U. Demirci17
  • S. Huang18
  • B. Abidi18
  • U. Patil18
  • B. Zhu19
19 affiliations
  1. 1Memorial Sloan Kettering Cancer Center, New York, NY, USA
  2. 2Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
  3. 3Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany
  4. 4National Center for Tumor Diseases West, Essen, Germany
  5. 5Christie NHS Foundation Trust and University of Manchester, Manchester, UK
  6. 6Fourth Department of Medical Oncology and Clinical Trials Unit, Henry Dunant Hospital Center, Athens, Greece
  7. 7Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
  8. 8Department of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China
  9. 9Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea
  10. 10Medical Oncology Unit, Azienda Ospedaliera San Giovanni Addolorata Hospital, Rome, Italy
  11. 11Department of Medical Oncology, Monash Health, Clayton, Australia
  12. 12Perlmutter Cancer Center, NYU Langone Health, NY, USA
  13. 13Department of Medical Oncology, University Hospital Vall d’Hebron, Vall d’Hebron Institute of Oncology, Barcelona, Spain
  14. 14Hospital Universitario 12 de Octubre, CNIO-H12O Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain
  15. 15Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France
  16. 16Istanbul Medeniyet University, Istanbul, Türkiye
  17. 17Department of Medical Oncology, Memorial Ankara Hospital, Ankara, Türkiye
  18. 18Amgen Inc., Thousand Oaks, CA, USA
  19. 19Second Affiliated Hospital of Army Medical University, Chongqing, China.
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Abstract

BACKGROUND: In the DeLLphi-304 trial, at a median follow-up of <12 months, tarlatamab significantly improved overall survival (OS; P < 0.001), progression-free survival (PFS; P = 0.002), and patient-reported outcomes (PROs), and demonstrated a favorable safety profile versus chemotherapy. We report efficacy and safety outcomes after extended follow-up in patients with small-cell lung cancer (SCLC). PATIENTS AND METHODS: In this phase III, open-label trial, patients with SCLC whose disease had progressed on or after platinum-based chemotherapy were randomly assigned (1 : 1) to receive either tarlatamab or chemotherapy (topotecan, lurbinectedin, or amrubicin) until disease progression, unacceptable toxicity, or death. The primary endpoint was OS. Secondary endpoints included investigator-assessed PFS, objective response, disease control, duration of response per RECIST v1.1, PROs, and safety. RESULTS: As of data cut-off (18 February 2026), median OS was 13.6 and 8.4 months with tarlatamab and chemotherapy, respectively (median follow-up, 23.3 and 22.8 months). Median PFS was 4.2 and 3.2 months, respectively (median follow-up, 22.2 and 21.9 months). Kaplan-Meier estimated OS rates at 12 and 24 months were 55.9% and 30.3% with tarlatamab versus 39% and 14.9% with chemotherapy; corresponding PFS rates at 12 and 24 months were 20.6% and 14.2% versus 5.9% and 2.3%. Objective response rate was 35.4% with tarlatamab, including six confirmed complete responses versus 20.4% with chemotherapy; at data cut-off, ongoing responses were observed in 31.1% (28 of 90) versus 3.8% (2 of 52) of responders, respectively. Sustained disease control for ≥52 weeks was observed in 24.4% versus 4.3%. Treatment-related adverse events (TRAEs) led to treatment discontinuation in 3.2% versus 6.6%; grade ≥3 events decreased over time, with no serious TRAEs with onset ≥12 months. Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome occurred early in treatment and were predominantly low grade. CONCLUSIONS: With extended follow-up, tarlatamab continues to demonstrate sustained and durable clinical benefit and a favorable long-term tolerability profile versus chemotherapy, in patients with SCLC after first-line platinum-based chemotherapy, supporting its use as the standard of care in this setting.

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Cite

BibTeXRIS
BibTeX
@article{rudin2026extended,
  title = {{Extended follow-up of tarlatamab in patients with small-cell lung cancer after platinum-based chemotherapy in the randomized phase 3 DeLLphi-304 study}},
  author = {C.M. Rudin and M-J. Ahn and M. Schuler and F.H. Blackhall and G. Mountzios and T. Yoshida and L. Sun and B.C. Cho and A. Lugini and S. Arulananda and S.R. Punekar and P. Rocha and L. Paz-Ares and J. Mazières and M. Gümüş and U. Demirci and S. Huang and B. Abidi and U. Patil and B. Zhu},
  journal = {Annals of oncology : official journal of the European Society for Medical Oncology},
  year = {2026},
  month = oct,
  doi = {10.1016/j.annonc.2026.10.095},
  url = {https://doi.org/10.1016/j.annonc.2026.10.095},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Extended follow-up of tarlatamab in patients with small-cell lung cancer after platinum-based chemotherapy in the randomized phase 3 DeLLphi-304 study
AU  - C.M. Rudin
AU  - M-J. Ahn
AU  - M. Schuler
AU  - F.H. Blackhall
AU  - G. Mountzios
AU  - T. Yoshida
AU  - L. Sun
AU  - B.C. Cho
AU  - A. Lugini
AU  - S. Arulananda
AU  - S.R. Punekar
AU  - P. Rocha
AU  - L. Paz-Ares
AU  - J. Mazières
AU  - M. Gümüş
AU  - U. Demirci
AU  - S. Huang
AU  - B. Abidi
AU  - U. Patil
AU  - B. Zhu
PY  - 2026
DA  - 2026/10/26
JO  - Annals of oncology : official journal of the European Society for Medical Oncology
DO  - 10.1016/j.annonc.2026.10.095
UR  - https://doi.org/10.1016/j.annonc.2026.10.095
AB  - BACKGROUND: In the DeLLphi-304 trial, at a median follow-up of <12 months, tarlatamab significantly improved overall survival (OS; P < 0.001), progression-free survival (PFS; P = 0.002), and patient-reported outcomes (PROs), and demonstrated a favorable safety profile versus chemotherapy. We report efficacy and safety outcomes after extended follow-up in patients with small-cell lung cancer (SCLC). PATIENTS AND METHODS: In this phase III, open-label trial, patients with SCLC whose disease had progressed on or after platinum-based chemotherapy were randomly assigned (1 : 1) to receive either tarlatamab or chemotherapy (topotecan, lurbinectedin, or amrubicin) until disease progression, unacceptable toxicity, or death. The primary endpoint was OS. Secondary endpoints included investigator-assessed PFS, objective response, disease control, duration of response per RECIST v1.1, PROs, and safety. RESULTS: As of data cut-off (18 February 2026), median OS was 13.6 and 8.4 months with tarlatamab and chemotherapy, respectively (median follow-up, 23.3 and 22.8 months). Median PFS was 4.2 and 3.2 months, respectively (median follow-up, 22.2 and 21.9 months). Kaplan-Meier estimated OS rates at 12 and 24 months were 55.9% and 30.3% with tarlatamab versus 39% and 14.9% with chemotherapy; corresponding PFS rates at 12 and 24 months were 20.6% and 14.2% versus 5.9% and 2.3%. Objective response rate was 35.4% with tarlatamab, including six confirmed complete responses versus 20.4% with chemotherapy; at data cut-off, ongoing responses were observed in 31.1% (28 of 90) versus 3.8% (2 of 52) of responders, respectively. Sustained disease control for ≥52 weeks was observed in 24.4% versus 4.3%. Treatment-related adverse events (TRAEs) led to treatment discontinuation in 3.2% versus 6.6%; grade ≥3 events decreased over time, with no serious TRAEs with onset ≥12 months. Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome occurred early in treatment and were predominantly low grade. CONCLUSIONS: With extended follow-up, tarlatamab continues to demonstrate sustained and durable clinical benefit and a favorable long-term tolerability profile versus chemotherapy, in patients with SCLC after first-line platinum-based chemotherapy, supporting its use as the standard of care in this setting.
SN  - 0923-7534
SN  - 1569-8041
ER  -