BioCentury
ARTICLE | Clinical News

AZ reports data from Phase I BLOOM trial of Tagrisso in NSCLC

July 7, 2017 8:14 PM UTC

AstraZeneca plc (LSE:AZN; NYSE:AZN) reported data from 21 evaluable EGFR mutation-positive non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases in the Phase I BLOOM trial showing that oral Tagrisso osimertinib (AZD9291) led to an overall leptomeningeal metastases response rate of 43%. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

The open-label, international trial is enrolling about 161 patients who had progressed on prior EGFR tyrosine kinase inhibitor (TKI) therapy to receive once-daily 160 mg Tagrisso or AZ's AZD3759, an EGFR TKI. The primary endpoint is safety. Secondary endpoints include pharmacokinetics, overall survival (OS), CSF response rate, CNS symptoms, quality of life (QOL), objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS)...