Imfinzi (durvalumab) förbättrar OS vid NSCLC

Imfinzi significantly improves overall survival in the Phase III PACIFIC trial for unresectable Stage III non-small cell lung cancer

Imfinzi met the second primary endpoint of overall survival which was both statistically-significant and clinically-meaningful at a planned interim analysis

AstraZeneca and MedImmune, its global biologics research and development arm, today announced positive overall survival (OS) results for the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of 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).

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 OS benefit with clinically-meaningful improvement in patients receiving Imfinzi compared to placebo. The safety and tolerability profile for Imfinzi was consistent with that reported at the time of the progression-free survival (PFS) analysis. AstraZeneca plans to present results from the PACIFIC trial at a forthcoming medical meeting.

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 that Imfinzi can 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 the Imfinzi label with these important data.”

In May 2017, AstraZeneca announced that the PACIFIC trial met its first primary endpoint of PFS by demonstrating a median improvement of 11.2 months vs. placebo, as assessed by blinded independent central review.

Imfinzi is currently approved in the US and Canada for the treatment of patients with unresectable Stage III NSCLC 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.

About Stage III NSCLC

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.

About PACIFIC

The PACIFIC trial is a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi as treatment in patients with Stage III unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy (CRT).

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

About Imfinzi

Imfinzi (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.

Earlier this month, Imfinzi received approval in Canada for the treatment of patients with unresectable Stage III NSCLC following chemoradiation therapy (CRT). In February 2018, Imfinzi received regulatory approval from the US FDA for the treatment of patients with unresectable Stage III NSCLC who had not progressed following concurrent platinum-based CRT.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with chemotherapy, radiation therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal antibody, as a first-line treatment for patients with NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.