Site Editor
Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Tuesday, November 19, 2024
A new biologics license application for accelerated approval recently has been submitted by Daiichi Sankyo and AstraZeneca for the TROP2-directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) for treatment of adults with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) who have received prior systemic therapies (including an EGFR-directed therapy). The previously submitted application, which was based on the phase III TROPION-Lung01 trial for patients with nonsquamous NSCLC, has been voluntarily withdrawn.
This recent application, which was informed by feedback from the U.S. Food and Drug Administration, is based on the TROPION-Lung05 phase II trial and supported by data from additional studies (including TROPION-Lung01 and TROPION-PanTumor01). New results from a pooled analysis of patients with previously treated EGFR-mutated NSCLC in the TROPION-Lung05 and TROPION-Lung01 trials will be featured in a late-breaking presentation at the upcoming European Society for Medical Oncology (ESMO) Asia Congress 2024.
TROPION-Lung05 is a global, multicenter, single-arm, open-label trial evaluating the efficacy and safety of Dato-DXd in 137 patients globally in Asia, Europe, and North America. Participants have locally advanced or metastatic NSCLC with actionable genomic alterations and have experienced disease progression on or after a regimen of platinum-based chemotherapy and at least one tyrosine kinase inhibitor (with or without other systemic therapies). Patients receiving up to four prior lines of treatment for tumors that have one or more genomic alterations (eg, EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET) were eligible for the trial. The primary trial endpoint is objective response rate as assessed by blinded independent central review. Secondary efficacy endpoints include duration of response, disease control rate, clinical benefit rate, progression-free survival, time to response, overall survival, and safety.
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