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Patient-reported outcomes for patients with previously treated small cell lung cancer receiving tarlatamab: results from the DeLLphi-301 phase 2 trial
Hummel, H. D. Ahn, M. J. Blackhall, F. Reck, M. Akamatsu, H. Ramalingam, S. S. Borghaei, H. Johnson, M. Dirnberger, F. Cocks, K.
Hummel, H. D.
Ahn, M. J.
Blackhall, F.
Reck, M.
Akamatsu, H.
Ramalingam, S. S.
Borghaei, H.
Johnson, M.
Dirnberger, F.
Cocks, K.
Abstract
INTRODUCTION: Tarlatamab demonstrated a durable response and promising survival outcomes in patients with previously treated small cell lung cancer (SCLC) in the phase 2, open-label DeLLphi-301 trial. Patient-reported outcomes (PROs) were evaluated to assess the benefit-risk profile of tarlatamab. METHODS: Patients received tarlatamab intravenously every 2 weeks at a dose of 10 mg (regulatory approved dose) or 100-mg until progression or loss of benefit. PROs, including European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (EORTC-QLQ-C30) and 13-item lung cancer module (LC13), Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and the GP5 question of the Functional Assessment of Cancer Therapy - General Form (FACT-GP5), were collected at Cycle 1 (days 1, 8, 22), Cycle 2 (days 1, 15) and every 6 weeks from Cycle 3 onwards. PROs were summarized descriptively alongside the amount and reason for missing data and analyzed using a mixed model for repeated measures. In addition, median time to deterioration (TTD) for symptom and functional scales was analyzed. RESULTS: A total of 100 patients were PRO-evaluable at the selected target dose (10 mg). EORTC-QLQ-C30 and LC13 completion rates (proportion of PRO assessments expected to be completed) were high (> 80%) throughout the study. Least square mean changes from baseline showed a trend towards improvement for the QLQ-C30 subscale of global health status and stabilization for physical functioning. Patients experienced reduced symptom burden for dyspnea which was more pronounced for patients at later cycles (≥ 10 points), and stabilization for chest pain and cough. Median TTD exceeded 6 months for cough and dyspnea and was not estimable for chest pain. Overall, tarlatamab was well tolerated with the majority of patients reporting no bother or a little bit of bother from side effects post baseline. Patient-reported adverse events were generally of mild to moderate severity occurring rarely or occasionally. CONCLUSION: Alongside previously reported antitumor activity, tarlatamab demonstrated a positive benefit-risk profile in previously treated SCLC with favorable PROs across a range of functional outcomes and symptoms, while showing manageable and sustained tolerability. GOV NUMBER: NCT05060016.
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Date
2025
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Citation
Hummel HD, Ahn MJ, Blackhall F, Reck M, Akamatsu H, Ramalingam SS, et al. Patient-reported outcomes for patients with previously treated small cell lung cancer receiving tarlatamab: results from the DeLLphi-301 phase 2 trial. Advances in therapy. 2025 Apr;42(4):1950-64. PubMed PMID: 40025391. Pubmed Central PMCID: PMC11929685. Epub 2025/03/03. eng.