AstraZeneca and MedImmune, its global biologics research and development arm, announced positive survival results for the Phase III PACIFIC trial, for Imfinzi(durvalumab) in patients with a type of Stage III non-small cell lung cancer.
A planned interim analysis concluded that the trial showed a benefit with clinically meaningful improvement in patients receivingImfinzicompared to placebo.
Sean Bohen, executive vice president, Global Medicines Development, and Chief Medical Officer at AstraZeneca, said: “The readout of positive overall survival data at the interim analysis of the PACIFIC trial provides additional compelling evidence of the clinical benefit thatImfinzican offer patients in this earlier stage of lung cancer. We look forward to sharing these results with Health Authorities to support ongoing regulatory interactions and to update theImfinzilabel with these important data.”
In May 2017, AstraZeneca announced that the PACIFIC trial met its first primary endpoint by demonstrating a median improvement of 11.2 months vs. placebo.
Imfinziis currently approved in the US and Canada for the treatment of patients with unresectable Stage III nonsmall cell lung cancer who had not progressed following platinum-based chemoradiation therapy and under regulatory review in the EU, Japan and other jurisdictions with expected decisions in the second half of 2018.
Stage III is defined by how much cancer has spread locally. This differentiates it from Stage IV disease when cancer has spread) to distant organs.
Stage III NSCLC represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in the top-eight countries (China, France, Germany, Italy, Japan, Spain, UK, US) in 2017.
The majority of Stage III NSCLC patients are diagnosed with tumors that can’t be completely removed by surgery. Before the PACIFIC trial, the standard of care was chemotherapy and radiation.