AstraZeneca (LON: AZN) and its global biologics research and development arm, MedImmune, have recorded positive results in the Phase III PACIFIC trial, the company announced on Friday.
The Phase III Pacific trial was a randomised, double-blind, placebo-controlled, multi-centre study involving Imfinzi (durvalumab) in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT). The data revealed positive overall survival (OS) results.
An Independent Data Monitoring Committee conducted a planned interim analysis and concluded that the trial had met its second of two primary endpoints by showing statistically-significant OS benefit with clinically-meaningful improvement in patients receiving Imfinzi compared to placebo.
Safety and tolerability for Imfinzi was found to be consistent with the profile reported in the progression-free survival (PFS) analysis. AstraZeneca plans to present these results at an upcoming medical meeting.
Imfinzi is currently approved as a treatment for patients with unresectable Stage III NSCLC who had not progressed following platinum-based chemoradiation therapy in the US and Canada. It is currently under regulatory review in the EU, Japan and other jurisdictions for this indication, with decisions expected in the second half of 2018.
Roivant to announce Q3 2026 financial results
Avacta secures FDA clearance for second pre|CISION oncology programme
OncoHost receives BIG Innovation Award in Health category
Summit Therapeutics and GSK form collaboration to study ivonescimab combination therapy
Summit Therapeutics submits FDA application for ivonescimab in EGFR-mutated lung cancer
Antin to acquire clinical trial equipment provider Emsere
Merck completes acquisition of Cidara Therapeutics for USD9.2bn
Bambusa Therapeutics reports first patient dosed in proof-of-concept COPD trial
Kelun-Biotech lung cancer drug granted Breakthrough Therapy Designation in China
INOVIO's INO-3107 Biologics License Application accepted by US FDA
Sanofi and Regeneron's Dupixent gains Japan approval for paediatric asthma patients aged 6 to 11
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA