**AstraZeneca (AZ) has announced that its immunotherapy Imfinzi (durvalumab) has been approved by the European Commission (EC) to treat adults with a highly aggressive form of lung cancer.**
The drug has been specifically authorised to treat patients with limited-stage small cell lung cancer (SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
Lung cancer is the leading cause of cancer-related deaths globally and SCLC, which progresses rapidly, accounts for around 15% of all cases.
Approximately 30% of SCLC patients have limited-stage disease, defined as SCLC that is generally only in one lung or one side of the chest, and face a particularly poor prognosis despite curative-intent treatment with standard-of-care concurrent CRT.
Imfinzi is already approved in the EU to treat extensive-stage SCLC, classed as SCLC that has spread to the other lung, the lymph nodes on the other side of the chest, or to distant organs.
The EC’s latest decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage ADRIATIC trial, in which Imfinzi was shown to reduce the risk of death by 27% compared to placebo.
Estimated median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo, and an estimated 57% of Imfinzi-treated patients were alive at three years compared to 48% of those in the placebo group.
Imfinzi was also found to reduce the risk of disease progression or death by 24% compared to placebo. Median progression-free survival was 16.6 months for Imfinzi versus 9.2 months for placebo, and an estimated 46% of patients randomised to receive Imfinzi had not experienced disease progression at two years compared to 34% for placebo.
Commenting on the latest authorisation for the therapy, Dave Fredrickson, executive vice president, oncology haematology business unit, AZ, said: “Imfinzi has the potential to transform how limited-stage SCLC is treated as the first immunotherapy approved in Europe in this setting.
“As the only immunotherapy approved for both early and late-stage disease, Imfinzi is poised to become the foundation for transforming outcomes for people with SCLC.”