Astrazeneca (AZN.US) has received breakthrough therapy designation for a potential blockbuster ADC.
According to Zhitong Finance APP, Astrazeneca (AZN.US) and Daiichi Sankyo announced that the USA FDA has granted breakthrough therapy designation (BTD) for their Trop2-targeted antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd), to treat adult patients with locally advanced or metastatic epidermal growth factor receptor mutations (EGFRm) non-small cell lung cancer (NSCLC), who have experienced disease progression after receiving EGFR tyrosine kinase inhibitors (TKI) and platinum-based chemotherapy. According to the press release, this is the first time datopotamab deruxtecan has received breakthrough therapy designation.
The FDA's grant of breakthrough therapy designation is primarily based on data from the TROPION-Lung05 phase 2 clinical trial, along with supportive data from the TROPION-Lung01 phase 3 clinical trial. Partial results from the TROPION-Lung05 trial, announced at this year's American Society of Clinical Oncology (ASCO) annual meeting, show that the intracranial (IC) objective response rate (ORR) among 18 treated patients with target brain lesions and locally advanced or metastatic NSCLC was 22% (95% CI: 6–48), with an IC disease control rate (DCR) of 72% (95% CI: 47–90). Among the 18 patients, 10 (56%) showed a reduction in the total sum of tumor diameters in the brain.
