AstraZeneca and MedImmune have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi 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 from the Phase III PACIFIC trial were published simultaneously in the New England Journal of Medicine, showing Imfinzi (durvalumab) significantly improved OS, the second primary endpoint of the trial, compared to standard of care 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).
“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,” says Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer.
Earlier this week, the European Commission has granted marketing authorisation for Imfinzi(durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The approval is based on results from the Phase III PACIFIC trial.
“Patients in Europe diagnosed with locally-advanced, unresectable non-small cell lung cancer now have a new treatment option. Imfinzi is the only immunotherapy to be approved in this curative-intent setting, and we are proud to bring a new standard of care for this difficult disease,” said Dave Fredrickson, Executive Vice President, Head of the Oncology Business.
The most common adverse reactions (greater than or equal to 20% of patients) of Imfinzi versus placebo were cough (40.2% vs. 30.3%), upper respiratory tract infections (26.1% vs 11.5%) and rash (21.7% vs 12.0%). 12.8% of patients experienced a grade 3 or 4 AE with Imfinzi vs 9.8% with placebo.
Imfinzi is approved for the treatment of patients with unresectable, Stage III (locally-advanced) NSCLC in the US, Canada, Switzerland, India, Japan and Brazil. Other global health authority reviews and submissions are ongoing.