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OBJECTIVE

This clinical study report evaluates efficacy and safety of the authorised product versus standard-of-care chemotherapy in treatment-naïve EGFR-positive metastatic NSCLC.

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ENDPOINTS

Primary endpoint: progression-free survival by blinded independent central review. Secondary: overall survival, objective response rate (RECIST 1.1), duration of response, and treatment-emergent adverse events.

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RESULTS

the authorised product improved progression-free survival in EGFR-positive NSCLC versus chemotherapy with a clinically meaningful hazard ratio favouring study treatment.

Overall response rate and duration of response were higher in the the authorised product arm. Safety was consistent with EGFR-targeted therapy including ILD and QT prolongation.

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LIMITATIONS

Population restricted to confirmed EGFR activating mutations. Findings must not be extrapolated beyond approved EU label scope.