AstraZeneca (DE, USA) and Medimmune (MD, USA), recently announced results from the ARCTIC trial in third-line non-small cell lung cancer (NSCLC).
The Phase III ARCTIC trial is a randomized, open label, multi-center trial to assess the efficacy and safety of the combination of Imfinzi ® (durvalumab) plus tremelimumab, in addition to Imfinzi and tremelimumab monotherapies, as opposed to standard-of-care chemotherapy (SoC) in patients with PDL1-low/negative NSCLC (sub-study B), and Imfinzi monotherapy versus SoC in patients with PDL1-high NSCLC (sub-study A).
AstraZeneca recently received approval from the US FDA for Imfinzi for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi is a human monoclonal antibody that binds to PD-L 1, countering the tumors immune-evading tactics and releasing the inhibition of immune responses.
The combination of Imfinzi plus tremelimumab in sub-study B patients did not yield statistically-significant and clinically-meaningful improvements in progression-free survival and overall survival compared to SoC. Additionally, the activity and safety of monotherapy arms of sub-study B were consistent with prior published data.
Within sub-study A, Imfinzi monotherapy demonstrated a clinically-meaningful reduction in the risk of death compared to chemotherapy; however, sub-study A was not powered for statistical significance.
“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,” concluded Executive Vice President, Global Medicines Development and Chief Medical Officer, Sean Bohen (AstraZeneca).