Astrazeneca's Imfinzi (durvalumab)

#Astrazeneca's #imfinzi has showed statistically significant and clinically meaningful results in a patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following concurrent chemoradiotherapy (cCRT) compared to placebo after cCRT in global phase III trial( # ADRIATIC). The primary end points for the trial are overall survival (OS) and progression-free survival (PFS) in diseased patients. The safety profile for imfinzi was consistent with its known profile, and no new safety signals were identified.

The second experimental arm testing the efficacy of imjudo(tremelimumab) added to?imfinzi as a secondary endpoint remains blinded and will continue to the next planned analysis.

Imfinzi is already been approved in the geographies of US, EU, Japan, China and many other countries for the treatment of extensive-stage SCLC (ES-SCLC) based on the CASPIAN Phase III trial. Imfinzi is also the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after CRT based on the PACIFIC Phase III trial.

The ADRIATIC trial is a randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluating Imfinzi monotherapy and imfinzi plus imjudo versus placebo in the treatment of 730 patients with LS-SCLC who had not progressed following cCRT. In the experimental arms, patients were randomised to receive a 1500mg fixed dose of imfinzi with or without imjudo 75mg every four weeks for up to four doses/cycles each, followed by imfinzi every four weeks for up to 24 months.