Business
ASTRAZENECA UPDATES MYSTIC TRIAL TIMELINE
ASTRAZENECA UPDATES MYSTIC TRIAL TIMELINE.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 3386H AstraZeneca PLC 12 March 2018 \n\n \n12 March 2018 07:00 GMT\n \nASTRAZENECA PROVIDES UPDATE ON MYSTIC TRIAL TIMELINE\n \nAstraZeneca 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). \n \nMYSTIC 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).\n \n \nAbout MYSTIC\nThe MYSTIC trial is a randomised, open-label, multi-centre, 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.\n \nThe 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.\n \nAbout Imfinzi\nImfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.\n \nIn February 2018, Imfinzi received US FDA approval for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi has also received accelerated approval in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.\n \nAs ...