NICE has approved durvalumab (Imfinzi) monotherapy for use within the Cancer Drugs Fund (CDF) as an option for locally advanced unresectable non-small-cell lung cancer (NSCLC) with PD-L1 expression of ≥1%, after concurrent platinum-based chemoradiation.
The main evidence for durvalumab comes from the PACIFIC trial, which reported improved progression-free survival (PFS) with durvalumab 10 mg/kg administered as an intravenous infusion over 60 minutes every two weeks (Q2W) or placebo.
At the latest data cut, median PFS was 23.9 months in the durvalumab arm and 5.6 months in the standard care arm (hazard ratio [HR] 0.44; 95% CI 0.31-0.63). Overall survival was also improved (HR 0.54; 95% CI 0.35-0.81), although the data were immature.
However, there are some issues with the PACIFIC trial. Firstly, the inclusion criteria limited participation to patients who had had concurrent chemoradiation, which creates uncertainty around the generalisability of the data to the UK situation, where the use of sequential chemoradiation is more common.
Furthermore, PACIFIC reported a median PFS of 5.6 months in the placebo arm, which is substantially shorter than the median PFS seen in the placebo arms of other trials.
Considering available evidence, NICE approved durvalumab for use within the CDF while further data is being collected. The decision will be reviewed once additional evidence is published.