AstraZeneca and its research and development unit MedImmune have reported overall survival (OS) data from the Phase III PACIFIC clinical trial of Imfinzi (durvalumab) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC).
Findings demonstrated that Imfinzi met the trial’s second primary endpoint with significant improvement in OS, when compared to standard of care.
The OS improved regardless of PD-L1 expression, with 32% decrease in the risk of death.
Imfinzi is a human monoclonal antibody designed to bind to PD-L1 and block its interaction with PD-1 and CD80, in turn inhibiting tumour’s evasion of the immune system.
PACIFIC is a randomised, double-blinded, placebo-controlled, multi-centre trial being conducted in 713 patients at 35 centres across 26 countries.
The trial’s primary endpoints are progression-free survival (PFS) and overall survival (OS), while the secondary endpoints include objective response rate and duration of response.
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AstraZeneca chief medical officer and Global Medicines Development executive vice-president Sean Bohen said: “These data establish Imfinzi as the first immunotherapy to demonstrate an overall survival benefit for patients with unresectable, Stage III non-small cell lung cancer following chemoradiation therapy.
“Today’s announcement brings new hope to patients in a setting where survival rates have not changed in decades.”
The OS data was presented at the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer in Toronto, Canada. The PACIFIC trial results were published in the New England Journal of Medicine.
AstraZeneca has also announced marketing authorisation from the European Commission (EC) for the use of Imfinzi as monotherapy to treat some adults with locally-advanced, unresectable NSCLC.
The drug has already secured approvals in the US, Canada, Switzerland, India, Japan and Brazil.
Stage III NSCLC is treated with curative intent because the cancer is yet to spread to distant organs, which is defined as Stage IV. It represents approximately one-third of NSCLC cases worldwide.