IMFINZI (durvalumab) US Label Updated With Overall Survival Data in Unresectable, Stage III Non-small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the inclusion of overall survival (OS) data from the Phase III PACIFIC trial in an update to the IMFINZI (durvalumab) US Prescribing Information for patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

The label update was based on results from the primary OS analysis published in The New England Journal of Medicine in September 2018 which demonstrated a significant and clinically-proven OS benefit for treatment with IMFINZI vs placebo in this setting, reducing the risk of death by 32% (HR 0.68, 95% CI, 0.53-0.87; P=0.0025).

In a follow-up three-year post-hoc OS analysis presented at the 2019 ASCO Annual Meeting, results for IMFINZI remained consistent with the two-year data showing a 31% reduction in the risk of death vs placebo (HR 0.69, 95% CI 0.55-0.86) and showing that 57% (95% CI 52.3-61.4) of patients on IMFINZI were still alive vs 44% (95% CI 37.0-49.9) of patients on placebo.

Olivier Nataf, Head of US Oncology, said, “This label update coupled with the recent three-year overall survival data continue to reinforce the PACIFIC regimen as the standard of care in this curative-intent setting. For patients and providers, this announcement provides further evidence and confidence in the survival benefit of IMFINZI.”

IMFINZI is approved for the treatment of unresectable, Stage III non-small cell lung cancer in more than 45 countries, including the US, EU and Japan, based on the Phase III PACIFIC trial. Since the first approval in February 2018, over 20,000 patients have been treated with IMFINZI in this setting. The National Comprehensive Cancer Network clinical practice guidelines in oncology (NCCN Guidelines) recommend durvalumab (IMFINZI) as the only Category 1 post-CRT consolidation immunotherapy for unresectable, Stage III NSCLC patients.^1,2

IMFINZI can cause serious, potentially fatal adverse events (AEs). In the previous two-year OS analysis, the most common adverse reactions (greater than or equal to 20% of patients) for patients receiving IMFINZI versus placebo were cough (35.2% vs 25.2%), fatigue (24.0% vs 20.5%), dyspnea (22.3% vs 23.9%) and radiation pneumonitis (20.2% vs 15.8%). 30.5% of patients experienced a grade 3 or 4 AE with IMFINZI vs 26.1% with placebo, and 15.4% of patients discontinued treatment due to AEs with IMFINZI vs 9.8% of patients on placebo.