AstraZeneca has revealed that its immunotherapy combo of Imfinzi (durvalumab) and tremelimumab failed to meet its primary endpoint in a recent Phase 3 trial in the treatment of previously untreated patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).

The results of the study showed that the combo, as well as Imfinzi alone, did not improve overall survival compared to standard of care chemotherapy in patients whose tumours express PD-L1 on more than 25% of their cancer cells.

"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," remarked Sean Bohen, AstraZeneca’s Executive Vice President, Global Medicines Development and Chief Medical Officer. "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."

Despite the disappointment, the company said that the safety and tolerability profiles remained consistent with previous studies, and that the data generated supported further analysis in exploratory subgroups.

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