Imfinzi (durvalumab) reduced the risk of death by nearly one-third compared to placebo in the phase III PACIFIC trial.
Results from the phase III PACIFIC trial in patients with unresectable stage III non-small cell lung cancer 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 percent (HR 0.68, 99.73% CI 0.47-0.997; p=0.0025).
Updated data reaffirm unprecedented improvement in progression-free survival of more than 11 months. AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival 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.
“The five-year survival rate in this setting has historically been around 15 percent after concurrent chemoradiation therapy,” said Scott Antonia, chair of the Thoracic Oncology Department at Moffitt Cancer Center and principal investigator in the PACIFIC trial. “The significant survival benefit observed using the PACIFIC regimen provides confidence and clear rationale for a new standard of care.”
Summary of primary endpoints:
The data cut-off date for first-planned OS analysis and updated PFS analysis was March 22, 2018.
Stratified by sex, age, and smoking history.
Confidence interval adjusted for interim analysis.
Criteria for statistical significance at the interim analysis of OS was a p-value ≤ 0.00274 for OS (using Lan DeMets spending function approximating O’Brien Fleming boundary).
Not Reached.
Assessed by Blinded Independent Central Review according to RECIST v1.1.
No formal statistical comparison was made because the study had achieved significance for PFS at the first planned interim analysis (data cutoff of Feb 13, 2017).
The safety and tolerability profile for Imfinzi was consistent with that reported at the time of the previous progression-free survival analysis. Imfinzi can cause serious, potentially fatal adverse reactions.
Imfinzi is currently approved in the U.S. 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.
