AstraZeneca's (AZN.US) groundbreaking immunotherapy Imfinzi is poised to secure approval in the European Union.

AstraZeneca (AZN.US) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Imfinzi (durvalumab) as a single agent for the treatment of adult patients with extensive-stage small cell lung cancer (SCLC) whose disease has not progressed following platinum-based chemotherapy (CRT).

This recommendation is based on the results of the Phase 3 ADRIATIC trial, which were published in the New England Journal of Medicine.

Small cell lung cancer (SCLC) is a highly aggressive form of lung cancer. Even after initial good response to standard chemotherapy and radiation, patients with limited-stage SCLC (LS-SCLC) typically experience rapid relapse and progression. The prognosis for LS-SCLC is particularly poor, with only 15%-30% of patients alive five years after diagnosis.

Dr. Suresh Senan, Professor of Clinical Trials and Radiation Oncology at the University Medical Center Utrecht in the Netherlands and the lead investigator of the ADRIATIC trial, said: "ADRIATIC is the first Phase 3 trial in decades to show a survival benefit in limited-stage small cell lung cancer, with a 27% reduction in the risk of death for patients treated with Imfinzi."

Imfinzi is a humanized monoclonal antibody that binds to PD-L1, blocking its interaction with the PD-1 and CD80 proteins, thereby inhibiting the immune escape mechanism of tumors.