AstraZeneca's (AZN.US) potential blockbuster ADC receives breakthrough therapy designation

AstraZeneca (AZN.US) and Daiichi Sankyo announced that the U.S. FDA granted breakthrough therapy designation to datopotamab deruxtecan (Dato-DXd), a Trop2-targeting antibody-drug conjugate (ADC), for the treatment of adult patients with non-small cell lung cancer (NSCLC) who have EGFR mutations and whose disease has progressed after EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy. This is the first breakthrough therapy designation for datopotamab deruxtecan, according to the press release.

The FDA granted the breakthrough therapy designation mainly based on the data from the TROPION-Lung05 clinical 2nd phase trial, and supported by the data from the TROPION-Lung01 clinical 3rd phase trial. The partial results of TROPION-Lung05 trial, which were presented at the American Society of Clinical Oncology (ASCO) annual meeting this year, showed that the intracranial (IC) objective response rate (ORR) was 22% (95% CI: 6–48) in 18 patients with target brain lesions who had previously treated locally advanced or metastatic NSCLC. Among the 18 patients, 10 (56%) had a total reduction in the size of brain tumors.