Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody drug conjugate, showed promising results in a pooled analysis of two clinical trials for patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The analysis demonstrated a confirmed objective response rate of 42.7% and a median overall survival of 15.6 months. This research focuses on patients whose disease progressed despite initial treatment with EGFR tyrosine kinase inhibitors, a common occurrence in this type of lung cancer.

This news is significant because it offers a potential new treatment option for patients with EGFR-mutated NSCLC who have limited effective therapies after their disease progresses on existing treatments, particularly osimertinib. The positive results highlight the potential for Dato-DXd to address a significant unmet medical need in this patient population, potentially changing the treatment landscape for advanced lung cancer. This is especially crucial given the prevalence of EGFR mutations in NSCLC, particularly in Asian populations.

The pooled analysis included 117 patients, with a subset of 96 having received prior osimertinib treatment. The confirmed objective response rate was consistent across both groups, around 43-45%, with a median duration of response of approximately 7 months. Notably, the median progression-free survival was about 5.7-5.8 months and median overall survival reached 14.7-15.6 months, suggesting potential for extended survival in this challenging patient population. The safety profile of Dato-DXd remained consistent with prior studies, with common side effects including stomatitis, alopecia, nausea, and fatigue. No new safety concerns were identified.

The positive data from this pooled analysis, particularly the durable responses and overall survival benefit observed, underscore the potential of Dato-DXd as a valuable treatment option for patients with advanced EGFR-mutated NSCLC who have progressed after standard therapies. This could lead to improved patient outcomes and potentially reshape the treatment paradigm in this challenging disease setting, offering a new avenue for patients who currently have limited effective options. The upcoming trials focusing on patients with TROP2-QCS biomarker-positive tumors could further refine the patient selection strategy and potentially maximize the benefits of Dato-DXd.

Source link: http://www.businesswire.com/news/home/20241205215995/en/Datopotamab-Deruxtecan-Demonstrated-Meaningful-Clinical-Activity-in-Patients-with-Previously-Treated-Advanced-EGFR-Mutated-Non-Small-Cell-Lung-Cancer-in-TROPION-Lung05-and-TROPION-Lung01-Pooled-Analysis

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.