Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced that their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA). The designation is based on the positive results from the Phase II TROPION-Lung05 study and the Phase III TROPION-Lung01 study, and the drug is intended for use in adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have experienced disease progression on or after treatment with an EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. This marks the first BTD for datopotamab deruxtecan.
Significant Benefits for Patients with Previously Treated EGFRm NSCLC
A pooled analysis of patients with previously treated EGFRm NSCLC from these studies demonstrated significant benefits from Dato-DXd treatment. The BTD underscores the potential impact of this treatment on patient outcomes in the specified population.
Ongoing Phase III Studies and Marketing Review in the US
Further Phase III studies, TROPION-Lung14 and TROPION-Lung15, are currently underway to assess the efficacy of Dato-DXd alone or in combination with epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) osimertinib in advanced or metastatic EGFR mutant non-squamous NSCLC patients. This indication is under marketing review in the US, with the potential to expand the treatment options for patients with this type of lung cancer.-Fineline Info & Tech
