August 2018
By Tom Newsom-Davis, Consultant Oncologist
On 26th July 2018 one of the European Medicines Agency (EMA) committees recommended that the immunotherapy drug, Durvalumab, be licensed for use in patients with locally advanced (stage III) lung cancer.
Although this does not mean that the drug is licensed quite yet, it does mean that this is likely to happen in the near future.
This decision was based on the PACIFIC clinical trial (N Engl J Med 2017; 377:1919-1929) involving patients with stage III non-small cell lung cancer. This compared chemotherapy and radiotherapy given together (concurrent chemoradiotherapy) to concurrent chemoradiotherapy followed by 12 months of Durvalumab. Patients who received Durvalumab had an improved progression-free survival at 12 months (55% vs. 25%) and a higher response rate (28% vs. 16%). The median time to death or distant metastases was longer (23.2 vs. 14.6 months). There was also an improved overall survival, details of which are expected shortly. The safety profile of both treatment regimens was similar.
Durvalumab is the first agent to improve outcomes, compared to chemoradiotherapy, for patients with this stage of disease. It is not yet approved for routine NHS use, but is available for a period via a compassionate access program.