TROPION-Lung08: phase III study of datopotamab deruxtecan plus pembrolizumab as first-line therapy for advanced NSCLC

Pembrolizumab monotherapy is a standard first-line treatment for PD-L1-high advanced non-small-cell lung cancer (NSCLC) without actionable genomic alterations (AGA). However, few patients experience long-term disease control, highlighting the need for more effective therapies. Datopotamab deruxtecan...

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Bibliographic Details
Published in:Future oncology (London, England) Vol. 19; no. 21; p. 1461
Main Authors: Levy, Benjamin P, Felip, Enriqueta, Reck, Martin, Yang, James Ch, Cappuzzo, Federico, Yoneshima, Yasuto, Zhou, Caicun, Rawat, Siddhartha, Xie, Jingdong, Basak, Priyanka, Xu, Lu, Sands, Jacob
Format: Journal Article
Language:English
Published: England 01.07.2023
Subjects:
Antineoplastic Agents - therapeutic use
Antineoplastic Combined Chemotherapy Protocols - adverse effects
B7-H1 Antigen - genetics
Carcinoma, Non-Small-Cell Lung
Clinical Trials, Phase III as Topic
Humans
Immunoconjugates - adverse effects
Lung Neoplasms - pathology
datopotamab deruxtecan
pembrolizumab
TROP2
antibody–drug conjugate
PD-L1
immuno-oncology
Dato-DXd
PD-1
non-small-cell lung cancer
ISSN:1744-8301, 1744-8301
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Summary:Pembrolizumab monotherapy is a standard first-line treatment for PD-L1-high advanced non-small-cell lung cancer (NSCLC) without actionable genomic alterations (AGA). However, few patients experience long-term disease control, highlighting the need for more effective therapies. Datopotamab deruxtecan (Dato-DXd), a novel trophoblast cell-surface antigen 2-directed antibody-drug conjugate, showed encouraging safety and antitumor activity with pembrolizumab in advanced NSCLC. We describe the rationale and design of TROPION-Lung08, a phase III study evaluating safety and efficacy of first-line Dato-DXd plus pembrolizumab versus pembrolizumab monotherapy in patients with advanced/metastatic NSCLC without AGAs and with PD-L1 tumor proportion score ≥50%. Primary end points are progression-free survival and overall survival; secondary end points include objective response rate, duration of response, safety and presence of antidrug antibodies. : NCT05215340 (ClinicalTrials.gov).
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ISSN:1744-8301
1744-8301
DOI:10.2217/fon-2023-0230