AstraZeneca’s Imfinzi has failed to show a significant benefit over standard of care (SoC) chemotherapy on overall survival in certain patients with lung cancer.
This is the finding of a preliminary analysis of data, from a population of previously-untreated patients with Stage IV (metastatic) NSCLC whose tumours express PD-L1 on 25% or more of their cancer cells, taken from the Phase III MYSTIC trial.
Imfinzi (durvalumab) monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving OS compared to SoC chemotherapy, AstraZeneca said.
However, while the OS result did not meet statistical significance, Imfinzi monotherapy showed enough of a benefit to warrant further analysis in exploratory subgroups, the drugs giant noted.
“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 AZ’ Sean Bohen, executive vice president, Global Medicines Development and chief medical officer.
“We remain confident in Imfinzi as the cornerstone of our immune-oncology 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.”
Earlier this year, the firm revealed data showing that the Imfinzi/tremelimumab combination in failed to show a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and OS compared to SoC in patients with PDL1-low/negative non-small cell lung cancer (NSCLC) who had received at least two prior treatments.