Durvalumab improves overall survival in PACIFIC trial for unresectable stage III non-small cell lung cancer
Positive overall survival ( OS ) results for the phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of Durvalumab ( Imfinzi ) 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 ) were announced.
A planned interim analysis conducted by an Independent Data Monitoring Committee concluded that the trial has met its second of two primary endpoints by showing statistically-significant overall survival benefit with clinically-meaningful improvement in patients receiving Durvalumab compared to placebo.
The safety and tolerability profile for Durvalumab was consistent with that reported at the time of the progression-free survival ( PFS ) analysis.
In May 2017, the PACIFIC trial met its first primary endpoint of progression-free survival ( PFS ) by demonstrating a median improvement of 11.2 months vs. placebo, as assessed by blinded independent central review.
Durvalumab is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.
Stage III ( locally-advanced ) NSCLC is commonly divided into three sub-categories ( IIIA, IIIB and IIIC ), defined by how much the cancer has spread locally and the possibility of surgery. This differentiates it from stage IV disease, when the cancer has spread ( metastasised ) 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 unresectable tumours.
Before the PACIFIC trial, the standard of care was chemotherapy and radiation therapy, followed by active surveillance to monitor for progression. ( Xagena )
Source: AstraZeneca, 2018