AstraZeneca’s (AZ) Imfinzi (durvalumab) has been recommended by the European Medicines Agency’s human medicines committee to treat an aggressive form of lung cancer.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the immunotherapy be approved to treat adults with limited-stage small cell lung cancer (SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
The committee’s decision, which comes just two months after the US Food and Drug Administration approved Imfinzi for the same indication, was supported by positive results from the phase 3 ADRIATIC trial.
Imfinzi demonstrated a 27% reduction in the risk of death 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.
AZ’s drug was also shown 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.
Lung cancer is the leading cause of cancer-related deaths globally and SCLC, which progresses rapidly, accounts for approximately 15% of all cases of the disease.
Around 30% of SCLC patients have limited-stage disease, classified 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 chemoradiotherapy.
AZ’s Imfinzi is a human monoclonal antibody designed to block the interaction of PD-L1 with the PD-1 and CD80 proteins, and is already approved by the European Commission (EC) 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 will now consider the CHMP’s recommendation as it makes its decision on Imfinzi in limited-stage disease.
Susan Galbraith, executive vice president, oncology haematology, research and development, AZ, said: “With 57% of patients still alive at three years in the ADRIATIC trial, Imfinzi has the potential to transform treatment for people with limited-stage SCLC.
“If approved, these patients will have access to immunotherapy for the first time, redefining expectations of survival outcomes in this setting.”