Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN), partners in the development of innovative oncology treatments, have jointly announced the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd). This application seeks accelerated approval for the treatment of previously treated EGFR mutant non-small cell lung cancer (NSCLC), marking a significant step in expanding treatment options for this patient population.
Supporting Clinical Data
The BLA filing is bolstered by positive results from the Phase II TROPION-Lung05 study, complemented by data from the Phase III TROPION-Lung01 studies. This comprehensive clinical evidence aims to demonstrate the efficacy and safety of Dato-DXd in treating NSCLC. In response to FDA feedback, a previous BLA for the drug’s use in non-squamous NSCLC (nsq NSCLC), supported by the TROPION-Lung01 study, was voluntarily withdrawn to align with the current regulatory strategy.
Clinical Impact and Ongoing Studies
A summary analysis of the TROPION-Lung05 and TROPION-Lung01 studies indicates that patients with locally advanced or metastatic EGFR mutant NSCLC, who have previously undergone systematic treatment including EGFR targeted therapy, can significantly benefit from Dato-DXd. This treatment is anticipated to offer a new option for later-line treatment of EGFR mutant NSCLC. Furthermore, the drug is under assessment in Phase III TROPION-Lung14 and TROPION-Lung15 studies, evaluating its use either as a monotherapy or in combination with the EGFR inhibitor osimertinib for advanced or metastatic EGFR mutant nsq NSCLC.-Fineline Info & Tech
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