Datopotamab deruxtecan extends PFS in advanced NSCLC; OS data remain immature
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Datopotamab deruxtecan improved PFS compared with standard chemotherapy for patients with advanced non-small cell lung cancer, according to topline data released by the agent’s manufacturer.
OS data remained immature.
Datopotamab deruxtecan (AstraZeneca/Daiichi Sankyo) is a TROP2-directed antibody-drug conjugate. TROP2 is highly expressed in a majority of lung cancers.
The randomized phase 3 TROPION-Lung01 trial included approximately 600 patients with locally advanced or metastatic NSCLC who received at least one prior therapy.
Study participants without actionable genomic alterations had received platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. Study participants with actionable genomic alterations received platinum-based chemotherapy and targeted therapy.
Researchers randomly assigned patients to datopotamab deruxtecan dosed at 6 mg/kg every 3 weeks or standard docetaxel dosed at 75 mg/m2.
PFS assessed by blinded independent central review and OS served as dual primary endpoints of the multicenter, open-label trial. Key secondary endpoints include investigator-assessed PFS, objective response rate, duration of response, time to response, disease control rate and safety.
Results showed a statistically significant PFS improvement among patients assigned datopotamab deruxtecan.
Researchers observed a trend toward improved OS with datopotamab deruxtecan, but the trial will continue to assess OS with greater maturity, according to an AstraZeneca-issued press release.
Datopotamab deruxtecan exhibited a safety profile consistent with that observed in prior trials. Researchers observed no new safety signals.
The majority of interstitial lung disease cases were low grade; however, investigators observed some grade 5 events, according to the press release.
Complete data from TROPION-Lung01 will be presented at a medical meeting and shared with regulatory authorities, according to the press release.
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