Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026
Datopotamab Deruxtecan Plus Pembrolizumab With or Without Platinum-Based Chemotherapy for Advanced or Metastatic NSCLC: The Phase Ib TROPION-Lung02 Trial.
СтатьяКлиническое исследование I фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Levy Benjamin, Paz-Ares Luis, Lin Chien-Chung, Herbert Scott, Yang Tsung-Ying, Tolcher Anthony, Lou Yanyan, Zenke Yoshitaka, Cortinovis Diego, Felip Enriqueta, Domine Manuel, Leventakos Konstantinos, Calvo Emiliano, Horiike Atsushi, Pan Edward, Basak Priyanka, Lin Daisy, Gu Wen, Chiaverelli Rachel, Chisamore Michael J, Goto Yasushi
Аннотация
INTRODUCTION: The phase Ib two-part (dose escalation and expansion) six-cohort TROPION-Lung02 study evaluated datopotamab deruxtecan (Dato-DXd) plus pembrolizumab with or without platinum-based chemotherapy (Pt-CT) in patients with advanced or metastatic NSCLC without actionable genomic alterations.
METHODS: Patients received Dato-DXd (4 or 6 mg/kg) plus pembrolizumab 200 mg alone (doublet) or with Pt-CT (triplet; carboplatin AUC 5 or cisplatin 75 mg/m2) once every 3 weeks. The primary objective was safety and tolerability; efficacy was a secondary objective. Exploratory biomarker analyses assessing TROP2 normalized membrane ratio by quantitative continuous scoring were performed in the treatment-naive patient subset.
RESULTS: In total, 142 patients received doublet (n = 70) or triplet (n = 72) therapy; 96 were treatment-naive (doublet: n = 42; triplet: n = 54). Grade 3 or higher treatment-related adverse events occurred in 37.1% (doublet) and 59.7% (triplet) of patients. No treatment-related deaths occurred. In treatment-naive patients receiving doublet therapy, the confirmed objective response rate was 54.8%, the median duration of response was 20.1 months, and the median progression-free survival was 11.2 months. With triplet therapy, the confirmed objective response rate was 55.6%, the median duration of response was 13.7 months, and the median progression-free survival was 6.8 months. Tumor responses were observed across programmed death-ligand 1 expression levels for both regimens. Exploratory TROP2 normalized membrane ratio biomarker analyses revealed trends toward improved survival outcomes in patients who were biomarker-positive compared with biomarker-negative.
CONCLUSION: Dato-DXd plus pembrolizumab therapy (with and without Pt-CT) exhibited appreciable safety and durable antitumor activity across programmed death-ligand 1 expression levels in patients with advanced or metastatic NSCLC.
CLINICAL TRIAL INFORMATION: ClinicalTrials.gov Identifier: NCT04526691.
METHODS: Patients received Dato-DXd (4 or 6 mg/kg) plus pembrolizumab 200 mg alone (doublet) or with Pt-CT (triplet; carboplatin AUC 5 or cisplatin 75 mg/m2) once every 3 weeks. The primary objective was safety and tolerability; efficacy was a secondary objective. Exploratory biomarker analyses assessing TROP2 normalized membrane ratio by quantitative continuous scoring were performed in the treatment-naive patient subset.
RESULTS: In total, 142 patients received doublet (n = 70) or triplet (n = 72) therapy; 96 were treatment-naive (doublet: n = 42; triplet: n = 54). Grade 3 or higher treatment-related adverse events occurred in 37.1% (doublet) and 59.7% (triplet) of patients. No treatment-related deaths occurred. In treatment-naive patients receiving doublet therapy, the confirmed objective response rate was 54.8%, the median duration of response was 20.1 months, and the median progression-free survival was 11.2 months. With triplet therapy, the confirmed objective response rate was 55.6%, the median duration of response was 13.7 months, and the median progression-free survival was 6.8 months. Tumor responses were observed across programmed death-ligand 1 expression levels for both regimens. Exploratory TROP2 normalized membrane ratio biomarker analyses revealed trends toward improved survival outcomes in patients who were biomarker-positive compared with biomarker-negative.
CONCLUSION: Dato-DXd plus pembrolizumab therapy (with and without Pt-CT) exhibited appreciable safety and durable antitumor activity across programmed death-ligand 1 expression levels in patients with advanced or metastatic NSCLC.
CLINICAL TRIAL INFORMATION: ClinicalTrials.gov Identifier: NCT04526691.