AstraZeneca: MYSTIC Trial Fails To Meet Significance In Overall Survival

(RTTNews) - AstraZeneca (AZN.L, AZN) and MedImmune, its global biologics research and development arm, announced final overall survival results for the Phase III MYSTIC trial, a global trial of Imfinzi monotherapy and the combination of Imfinzi and tremelimumab, an anti-CTLA4 antibody, versus standard-of-care platinum-based chemotherapy in previously-untreated patients with Stage IV non-small cell lung cancer. In the primary analysis population of patients, whose tumours express PD-L1 on 25% or more of their cancer cells, Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving overall survival compared to SoC chemotherapy.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "We are disappointed that these results missed statistical significance. We remain confident in Imfinzi as the cornerstone of our IO programme and continue to evaluate its potential in ongoing non-small cell lung cancer trials, including Imfinzi and Imfinzi plus tremelimumab in combination with chemotherapy."

Imfinzi is approved for unresectable, Stage III NSCLC in more than 40 countries, including the US, EU and Japan, based on the Phase III PACIFIC trial.