AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi (durvalumab) during the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Toronto, Canada. Results were published simultaneously in the New England Journal of Medicine.
Results from the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following chemoradiation showed that Imfinzi significantly improved OS, the second primary endpoint of the trial, compared to placebo regardless of PD-L1 expression, reducing the risk of death by 32% (HR 0.68, 99.73% CI 0.47-0.997; p=0.0025).
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “These data establish Imfinzi as the first immunotherapy to demonstrate an overall survival benefit for patients with unresectable, Stage III non-small cell lung cancer following chemoradiation therapy. Today’s announcement brings new hope to patients in a setting where survival rates have not changed in decades.”
Imfinzi is currently approved in the US for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, based on the PACIFIC trial. It is also approved in the EU, Canada, Switzerland, India, Japan and Brazil. Other global health authority reviews and submissions are ongoing.
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses. It has been associated with a number of immune mediated reactions, some of them fatal.
Imfinzi is approved for unresectable Stage III NSCLC in the US, EU, Canada, Switzerland, India, Japan, and Brazil based on the Phase III PACIFIC trial.
As part of a broad development program, Imfinzi is also being tested as a monotherapy and in combination with chemotherapy, radiation therapy, small molecules and tremelimumab, an investigational anti-CTLA4 monoclonal antibody, as a first- or second-line treatment for patients with NSCLC, small cell lung cancer, locally advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumors.