(WebFG News) - AstraZeneca, alongside its its biologics research and development arm MedImmune, announced high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who had received at least two prior treatments on Tuesday.
The FTSE 100 drugmaker said the randomised, open-label, multi-centre trial assessed the efficacy and safety of the combination of Imfinzi (durvalumab) plus tremelimumab, as well as Imfinzi and tremelimumab monotherapies, compared to standard-of-care chemotherapy in patients with PDL1-low/negative NSCLC - sub-study B - and Imfinzi monotherapy versus standard of care in patients with PDL1-high NSCLC - sub-study A.

In sub-study B, the combination of Imfinzi plus tremelimumab in patients with PD-L1 low or negative NSCLC did not meet the primary endpoints of a "statistically-significant and clinically-meaningful improvement in progression-free survival" and overall survival compared to standard of care.

Activity and safety of monotherapy arms of sub-study B were consistent with prior published data, AstraZeneca reported.

Sub-study A was not powered for statistical significance; however, Imfinzi monotherapy apparently showed a "clinically-meaningful reduction" in the risk of death compared to chemotherapy.

"While we are disappointed that the combination of Imfinzi plus tremelimumab did not result in a statistically-significant survival benefit in this heavily pre-treated patient population, we are encouraged by the activity of Imfinzi monotherapy observed in this trial and look forward to presenting the full data from the ARCTIC trial at an upcoming medical meeting," said Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca.

The company had recently received approval from the US FDA for Imfinzi, for the treatment of patients with unresectable, Stage III NSCLC whose disease had not progressed following concurrent platinum-based chemotherapy and radiation therapy.

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