2023 World Conference on Lung Cancer (Posters)-P2.08. TROPION-Lung08: Datopotamab Deruxtecan Plus Pembrolizumab in Untreated Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC)

P2.08. TROPION-Lung08: Datopotamab Deruxtecan Plus Pembrolizumab in Untreated Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) - PDF(Abstract)

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The TROPION-Lung08 trial is a phase 3 study evaluating the combination treatment of datopotamab deruxtecan (Dato-DXd) and pembrolizumab in treatment-naive patients with advanced/metastatic non-small cell lung cancer (NSCLC). The trial aims to compare the efficacy and safety of this combination therapy with pembrolizumab alone in patients without actionable genomic alterations and with PD-L1 expression of 50% or greater. <br /><br />Dato-DXd is an antibody-drug conjugate composed of a humanized anti-TROP2 monoclonal antibody linked to a topoisomerase I inhibitor. In earlier studies, Dato-DXd monotherapy showed promising results in pretreated patients with NSCLC, with an objective response rate (ORR) of 28% and a manageable safety profile. Preclinical studies supported the investigation of Dato-DXd combined with anti-PD-1 and anti-PD-L1 antibodies.<br /><br />In the phase 1b TROPION-Lung02 trial, Dato-DXd combined with pembrolizumab demonstrated tolerability and promising efficacy as first-line therapy. The preliminary ORR for this combination was 62%, and the disease control rate was 100%.<br /><br />The ongoing TROPION-Lung08 trial aims to enroll approximately 740 patients who will be randomized to receive Dato-DXd plus pembrolizumab or pembrolizumab alone every 21 days until disease progression or discontinuation. Stratification will be done based on various factors including performance status, histology, geographic region, and smoking status.<br /><br />The primary endpoints of the study are progression-free survival (PFS) and overall survival, with secondary endpoints including objective response rate, PFS as assessed by investigators, duration of response, safety, and biomarkers. The study is also exploring pharmacokinetic parameters, patient-reported outcomes, and the prevalence of antidrug antibodies.<br /><br />In summary, the TROPION-Lung08 trial is investigating the combination therapy of Dato-DXd and pembrolizumab in treatment-naive patients with advanced/metastatic NSCLC. This study aims to determine the efficacy and safety of this combination compared to pembrolizumab alone and explore various secondary endpoints.

Asset Subtitle

Caicun Zhou

Meta Tag

Speaker Caicun Zhou

Topic Metastatic NSCLC: Immunotherapy - TIPs

Keywords

TROPION-Lung08 trial

phase 3 study

datopotamab deruxtecan

Dato-DXd

pembrolizumab

non-small cell lung cancer

NSCLC

combination therapy

progression-free survival

overall survival