AZ's Imfinzi misses PFS endpoint in Phase III MYSTIC trial for first-line NSCLC

AstraZeneca plc (LSE:AZN; NYSE:AZN) reported data from the Phase III MYSTIC trial to treat non-small cell lung cancer (NSCLC) showing that first-line treatment with Imfinzi durvalumab plus tremelimumab (CP-675) missed the co-primary endpoint of improving progression-free survival (PFS) in patients whose tumors express PD-L1 on 25% or more of their cancer cells vs. standard of care (SOC) chemotherapy. The trial enrolled about 1,118 patients with previously untreated, wild-type EGFR and anaplastic lymphoma kinase (ALK), locally advanced or metastatic NSCLC. AZ also said Imfinzi monotherapy would not have met the prespecified threshold for PFS benefit over SOC, a secondary endpoint.

Data for the trial's other co-primary endpoint of overall survival (OS) are expected in 1H18. The open-label, international trial's secondary endpoints also include objective response rate (ORR) for Imfinzi monotherapy and for Imfinzi plus tremelimumab...