24th Apr 2018 08:18
LONDON (Alliance News) - AstraZeneca PLC said Tuesday its Imfinzi combination late stage clinical trial for metastatic non-small cell lung cancer had mixed results after one sub-study failed to meet any of its primary endpoints, though another did provide "clinically meaningful" results.
The ARCTIC Phase III trial for Imfinzi - or durvalumab - with tremelimumab had two sub-studies focused on PDL1-low/negative NSCLC patients and PDL1-high NSCLC patients. Imfinzi is a monoclonal antibody that binds to PD-L1.
The PDL1-low/negative sub-study "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 chemotherapy.
In contrast, for patients with PDL1-high the study - although not powered for statistical significance - did show a "clinically-meaningful reduction" in the risk of death comapred to chemotherapy.
AstraZeneca Global Medicines Development Executive Vice President Sean Bohen said: "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."
Imfinzi is already approved in the US for treatment of patients with stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. This was approved in February.
Shares in AstraZeneca were 0.8% lower at 4,975.50 in early trading Tuesday in London.
Related Shares:
Astrazeneca