A comprehensive analysis combining results from the TROPION-Lung05 phase 2 trial and the TROPION-Lung01 phase 3 trial reveals that datopotamab deruxtecan (Dato-DXd), developed by Daiichi Sankyo and AstraZeneca, has shown significant tumor response in patients with advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously undergone treatment, the companies announced.
Datopotamab deruxtecan is an engineered antibody-drug conjugate (ADC) targeting TROP2, originating from Daiichi Sankyo’s research, with development efforts being a joint collaboration between Daiichi Sankyo and AstraZeneca.
The pooled analysis, which included 117 patients with EGFR-mutated NSCLC, reported a confirmed objective response rate (ORR) of 42.7%, based on evaluations conducted by a blinded independent central review (BICR). Among these patients, 4.3% achieved complete response, 38.5% had partial responses, and 41.0% had stable disease.
The median duration of response was noted to be 7.0 months, while the disease control rate (DCR) reached 86.3%. Additionally, the median progression-free survival was documented at 5.8 months, with a median overall survival of 15.6 months observed.
The safety profile of datopotamab deruxtecan was in alignment with previous findings from the TROPION-Lung05 and TROPION-Lung01 trials. Notably, no new safety concerns were identified, and there were no incidences of grade 4 or 5 stomatitis, ocular surface complications, or drug-related interstitial lung disease (ILD) events as adjudicated by the trials.
