AstraZeneca and MedImmune announce an updated timeline for the final analysis of the Phase III MYSTIC trial of Imfinzi (durvalumab) as monotherapy and in combination with tremelimumab, versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer (NSCLC).
MYSTIC is an event-driven clinical trial and continues per protocol. Based on current predictions, the final analysis of overall survival (OS) is now expected in the second half of 2018 (previously anticipated in the first half).
The MYSTIC trial is a randomised, open-label, multi-centre, global Phase III trial of Imfinzimonotherapy or Imfinzi in combination with tremelimumab versus SoC in treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally-advanced or metastatic (Stage IV) 1st-line NSCLC.
The trial is being conducted in 167 centres across 17 countries, including the US, Canada, Europe, Russia, Australia and parts of Asia including Japan, Korea, Thailand, Taiwan and Vietnam. Primary endpoints include progression-free survival (in combination), which read out in July 2017, and OS in monotherapy and in combination.