EU approves Imfinzi for locally advanced unresectable NSCLC.- AstraZeneca + MedImmune.

AstraZeneca and MedImmune announced that the European Commission has granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The approval is based on results from the Phase III PACIFIC trial. The PACIFIC trial is a Phase III, randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi as treatment in �all-comer� patients (i.e. regardless of PD-L1 status) with unresectable, Stage III (locally-advanced) NSCLC whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).

The most common adverse reactions (greater than or equal to 20% of patients) of Imfinzi versus placebo were cough (40.2% vs. 30.3%), upper respiratory tract infections (26.1% vs 11.5%) and rash (21.7% vs 12.0%). 12.8% of patients experienced a grade 3 or 4 AE with Imfinzi vs 9.8% with placebo.