BRIEF—AstraZeneca updates on MYSTIC trial timeline

Anglo-Swedish pharma major AstraZeneca and MedImmune, its global biologics research and development arm, today announced 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 randomized, open-label, multicenter, global Phase III trial of Imfinzi monotherapy 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 centers across 17 countries, including the USA, 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.

In February 2018, Imfinzi received US Food and Drug Administration approval for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.