AstraZeneca (AZ) has announced that the National Institute for Health and Care Excellence (NICE) has approved the routine use of Imfinzi (durvalumab) within NHS England as a monotherapy to treat locally advanced stage 3 unresectable non-small-cell lung cancer (NSCLC).
The regulatory approval is specifically for adults whose tumours present a protein called PD-L1 on at least 1% of tumour cells and whose disease has not progressed following concurrent platinum-based chemoradiation therapy (cCRT).
Lung cancer is the cancer with the highest mortality rate and accounts for more than one in five (21%) of all deaths caused by cancer. It is estimated that over 34,000 people in England are diagnosed with NSCLC each year, with roughly 20% of these patients receiving a diagnosis at stage 3.
There are treatment options available for those diagnosed with stage 3 NSCLC, however if a patient progresses to stage 4 – otherwise known as metastatic cancer – the options available to that patient are often limited to the prolonging of life and supportive care provisions.
Imfinzi was made available as a treatment option for these patients via the Cancer Drugs Fund (CDF) – a scheme that provides patients with faster access to new cancer treatments – in May 2019.
NICE has recommended routine access to this treatment following an assessment of additional efficacy and safety data for Imfinzi in these patients.
Recently updated long-term results from the PACIFIC phase 3 trial showed an approximate five-year overall survival (OS) rate of 42.9% for Imfinzi versus 33.4% for placebo, establishing a new benchmark in this setting.
Dr Patricia Fisher, consultant clinical oncologist at Sheffield Teaching Hospitals NHS Foundation Trust, said: “Sadly not all people with stage 3 unresectable non-small cell lung cancer are treated with the intention to cure and those that are, many will progress to develop advanced incurable disease.
“Since durvalumab was made available within the CDF, we have seen a significant shift to more patients being treated with concurrent chemoradiation therapy because they then have the option to follow this with immunotherapy, giving them the chance of improved outcomes. The positive recommendation by NICE should increase clinician confidence in using a combination of therapies in this setting.”
The long-term results build on the primary progression-free survival and OS data published in The New England Journal of Medicine in 2017 and 2018, which showed a sustained and significant benefit with Imfinzi for these primary endpoints.