Therapy Areas: Cardiovascular
AstraZeneca reports recommendation of CHMP of Imfinzi for stage III NSCLC
30 July 2018 -

Science-led biopharmaceutical company AstraZeneca Plc (LON:AZN) and MedImmune, AstraZeneca's global biologics research and development arm, announced on Friday the adoption by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency of a positive opinion, recommending a marketing authorisation of Imfinzi (durvalumab) for the treatment of locally -advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on =1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).

Reportedly, this recommendation is based on the progression-free survival (PFS) and overall survival (OS) primary endpoints of the phase III PACIFIC trial and post-hoc subgroup analyses by PD-L1 expression requested by the CHMP.

In the PACIFIC trial, Imfinzi demonstrated a statistically-significant and clinically-meaningful improvement in PFS and OS in 'all-comer' patients. The recommended label reflects most of the patients in the trial with a known PD-L1 status.

According to the company, the overall survival results from the PACIFIC trial will be presented at a forthcoming medical meeting.

Now, this positive opinion from the CHMP will be reviewed by the European Commission, which has the authority to approve medicines for the 28 EU member countries plus Iceland, Norway and Liechtenstein. Earlier this year, Imfinzi was approved for unresectable, stage III NSCLC in the US, Canada, Switzerland, India, Japan and Brazil based on the phase III PACIFIC trial. In addition to the EU, other global health authority reviews and submissions are ongoing.

The PACIFIC trial is a 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 NSCLC whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).

This trial is being conducted in 235 centres across 26 countries involving 713 patients. The primary endpoints of the trial are PFS and OS, while secondary endpoints include landmark PFS and OS, objective response rate and duration of response.

AstraZeneca is focussed on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.



Related Headlines