Imfinzi Approved in EU as First Immunotherapy for Limited-Stage SCLC

AstraZeneca's Imfinzi (durvalumab) has received approval in the European Union (EU) for use as a monotherapy in adults with limited-stage small cell lung cancer (LS-SCLC). The treatment is specifically for patients whose disease has not progressed after undergoing platinum-based chemoradiation therapy (CRT). The European Commission granted approval following the positive recommendation from the Committee for Medicinal Products for Human Use (CHMP).

Small cell lung cancer (SCLC) is an aggressive type of lung cancer. Each year, approximately 8,000 patients are treated for LS-SCLC across the five major European countries. Despite an initial positive response to chemotherapy and radiotherapy, LS-SCLC often recurs and progresses rapidly. The survival rate remains low, with only 15-30% of patients living beyond five years after diagnosis.

Progression-free survival (PFS) was also improved, with Imfinzi reducing the risk of disease progression or death by 24% compared to placebo. The median PFS was 16.6 months for Imfinzi, compared to 9.2 months for placebo. At two years, 46% of patients treated with Imfinzi had not experienced disease progression, compared to 34% of those receiving placebo.

Imfinzi is already approved for LS-SCLC in the United States and other regions based on the ADRIATIC trial results. Regulatory reviews for this indication are ongoing in Japan and several other countries. The medicine is also approved in combination with chemotherapy for extensive-stage SCLC, based on the CASPIAN Phase III trial.

The trial's primary endpoints were PFS and OS for Imfinzi monotherapy versus placebo. Secondary endpoints included OS and PFS for the combination treatment, safety assessments, and quality of life measures.

Imfinzi (durvalumab) is a monoclonal antibody that targets PD-L1, preventing its interaction with PD-1 and CD80 proteins. This helps the immune system recognise and attack cancer cells. Recent trial results also show that perioperative Imfinzi, combined with standard chemotherapy, improved event-free survival in resectable gastric and gastroesophageal junction cancers. Additionally, Imfinzi is approved in combination with chemotherapy for advanced or recurrent endometrial cancer.