Tarlatamab in small cell lung cancer following platinum-based chemotherapy: subgroup analysis of Japanese patients from the DeLLphi-304 study
19 affiliations
- 1Department of Thoracic Oncology, Kansai Medical University Hospital, 2-3-1 Shin-machi, Hirakata city, Osaka 573-1191 Japan
- 2Sendai Kousei Hospital, Miyagi, Japan
- 3Internal Medicine III, Wakayama Medical University Hospital, Wakayama, Japan
- 4Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan
- 5Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan
- 6Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
- 7Department of Respiratory Medicine, International Medical Center, Saitama Medical University, Saitama, Japan
- 8Department of Respiratory Medicine, NHO Hokkaido Cancer Center, Sapporo, Japan
- 9Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan
- 10Department of Thoracic Oncology, Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center, Yokohama, Japan
- 11Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan
- 12Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
- 13Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan
- 14Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan
- 15Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan
- 16Department of Respiratory Medicine, Graduate School of Medicine, Juntendo University, Tokyo, Japan
- 17Amgen Inc, Thousand Oaks, CA USA
- 18Amgen K.K, Tokyo, Japan
- 19Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
Abstract
Background: In the Phase 3 DeLLphi-304 trial, tarlatamab significantly improved overall survival (OS) over chemotherapy for small-cell lung cancer (SCLC) progressed after platinum-based chemotherapy. We report efficacy and safety in the Japanese subpopulation.
Methods: Patients were randomized to tarlatamab or amrubicin in Japan. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and safety.
Results: As of 29 Jan 2025 (data cutoff), 35 patients (tarlatamab, n = 12; amrubicin, n = 23) were enrolled. Baseline characteristics were generally balanced although fewer tarlatamab-treated patients had chemotherapy-free interval < 90 days or brain metastases. Median OS was NE (95% CI, 10.4, NE) for tarlatamab versus 11.5 (6.2, NE) months for amrubicin (HR [95% CI] = 0.533 [0.186, 1.529]). Twelve-month survival was 66.7% (33.7, 86.0) versus 47.0% (25.7, 65.6), respectively. Median PFS was 4.0 (1.3, 11.3) months versus 4.2 (2.1, 5.4) months (HR [95% CI] = 0.726 [0.339, 1.554]). ORR was 33.3% (9.9, 65.1) versus 26.1% (10.2, 48.4). Median DOR was 10.1 (3.0, NE) months versus 5.6 (2.8, NE) months. Grade ≥ 3 treatment-related adverse events were less frequent with tarlatamab (8.3%) versus amrubicin (56.5%). Cytokine release syndrome occurred in 75% of tarlatamab-treated patients (all were grade 1 or 2) and grade 2 immune effector cell-associated neurotoxicity syndrome was reported in 1 (8.3%) patient.
Conclusion: Tarlatamab demonstrated numerically longer OS and DOR, and higher ORR versus amrubicin in Japanese patients with SCLC, with fewer high-grade treatment-related adverse events. These results in Japanese patients support those of the global population.
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s10147-026-03192-y.
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BibTeX
@article{kurata2026tarlatamab,
title = {{Tarlatamab in small cell lung cancer following platinum-based chemotherapy: subgroup analysis of Japanese patients from the DeLLphi-304 study}},
author = {Takayasu Kurata and Shunichi Sugawara and Hiroaki Akamatsu and Kazushige Wakuda and Koichi Azuma and Takayuki Takahama and Hiroshi Kagamu and Hiroshi Yokouchi and Miyako Satouchi and Shuji Murakami and Kadoaki Ohashi and Makoto Nishio and Kazumi Nishino and Hiroki Izumi and Hiroshi Tanaka and Taichi Miyawaki and Shuang Huang and Upen Patil and Jihyun Park and Tatsuya Yoshida},
journal = {International Journal of Clinical Oncology},
year = {2026},
month = sep,
doi = {10.1007/s10147-026-03192-y},
url = {https://doi.org/10.1007/s10147-026-03192-y},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Tarlatamab in small cell lung cancer following platinum-based chemotherapy: subgroup analysis of Japanese patients from the DeLLphi-304 study
AU - Takayasu Kurata
AU - Shunichi Sugawara
AU - Hiroaki Akamatsu
AU - Kazushige Wakuda
AU - Koichi Azuma
AU - Takayuki Takahama
AU - Hiroshi Kagamu
AU - Hiroshi Yokouchi
AU - Miyako Satouchi
AU - Shuji Murakami
AU - Kadoaki Ohashi
AU - Makoto Nishio
AU - Kazumi Nishino
AU - Hiroki Izumi
AU - Hiroshi Tanaka
AU - Taichi Miyawaki
AU - Shuang Huang
AU - Upen Patil
AU - Jihyun Park
AU - Tatsuya Yoshida
PY - 2026
DA - 2026/09/19
JO - International Journal of Clinical Oncology
DO - 10.1007/s10147-026-03192-y
UR - https://doi.org/10.1007/s10147-026-03192-y
AB - Background: In the Phase 3 DeLLphi-304 trial, tarlatamab significantly improved overall survival (OS) over chemotherapy for small-cell lung cancer (SCLC) progressed after platinum-based chemotherapy. We report efficacy and safety in the Japanese subpopulation. Methods: Patients were randomized to tarlatamab or amrubicin in Japan. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and safety. Results: As of 29 Jan 2025 (data cutoff), 35 patients (tarlatamab, n = 12; amrubicin, n = 23) were enrolled. Baseline characteristics were generally balanced although fewer tarlatamab-treated patients had chemotherapy-free interval < 90 days or brain metastases. Median OS was NE (95% CI, 10.4, NE) for tarlatamab versus 11.5 (6.2, NE) months for amrubicin (HR [95% CI] = 0.533 [0.186, 1.529]). Twelve-month survival was 66.7% (33.7, 86.0) versus 47.0% (25.7, 65.6), respectively. Median PFS was 4.0 (1.3, 11.3) months versus 4.2 (2.1, 5.4) months (HR [95% CI] = 0.726 [0.339, 1.554]). ORR was 33.3% (9.9, 65.1) versus 26.1% (10.2, 48.4). Median DOR was 10.1 (3.0, NE) months versus 5.6 (2.8, NE) months. Grade ≥ 3 treatment-related adverse events were less frequent with tarlatamab (8.3%) versus amrubicin (56.5%). Cytokine release syndrome occurred in 75% of tarlatamab-treated patients (all were grade 1 or 2) and grade 2 immune effector cell-associated neurotoxicity syndrome was reported in 1 (8.3%) patient. Conclusion: Tarlatamab demonstrated numerically longer OS and DOR, and higher ORR versus amrubicin in Japanese patients with SCLC, with fewer high-grade treatment-related adverse events. These results in Japanese patients support those of the global population. Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s10147-026-03192-y.
SN - 1341-9625
SN - 1437-7772
ER -