AstraZeneca's Imfinzi fails to meet endpoint in latest trial
By Josh White
Date: Friday 16 Nov 2018
(Sharecast News) - AstraZeneca and its global biologics research and development arm MedImmune announced final overall survival results for the Phase III MYSTIC trial on Friday.
The FTSE 100 drugmaker said the trial was a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy and the combination of Imfinzi and tremelimumab - an anti-CTLA4 antibody - compared to standard-of-care platinum-based chemotherapy in previously-untreated patients with stage IV, metastatic, non-small cell lung cancer.
It said that in the primary analysis population of patients, whose tumours expressed PD-L1 on 25% or more of their cancer cells as determined by the VENTANA PD-L1 (SP263) assay, Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving overall survival compared to standard-of-care chemotherapy.
While the overall survival result did not meet statistical significance, a hazard ratio of 0.76 was observed with Imfinzi monotherapy.
The company said the combination therapy had an hazard ratio of 0.85, with the data supporting further analysis in exploratory subgroups.
AstraZeneca said the safety and tolerability profiles for Imfinzi and the Imfinzi plus tremelimumab combination were consistent with previous trials.
"We are encouraged to see that Imfinzi monotherapy activity is in-line with that of the anti-PD-1 class in previously-untreated patients with stage IV non-small cell lung cancer; however, we are disappointed that these results missed statistical significance," said AstraZeneca's executive vice-president of global medicines development and chief medical officer Sean Bohen.
"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 currently approved for unresectable, stage III non-small cell lung cancer in more than 40 countries, including the US, EU and Japan, based on the Phase III PACIFIC trial.
It is currently being tested in a range of phase III trials for stage IV non-small cell lung cancer.
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