AstraZeneca and its subsidiary MedImmune have reported positive results for the Phase III PACIFIC trial of Imfinzi (durvalumab) as sequential treatment in patients with locally-advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy.
According to Independent Data Monitoring Committee’s (IDMC) interim analysis the trial has already met a primary endpoint by showing statistically-significant and clinically-meaningful PFS, AstraZeneca said in its press release issued on Friday.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “These are highly encouraging results for patients with locally-advanced lung cancer for whom surgery is not an option. We look forward to working with regulatory authorities around the world to bring Imfinzi to lung cancer patients as soon as possible. Alongside this, we continue to explore Imfinzi’s full potential as monotherapy as well as in combination with tremelimumab and other medicines in areas of continued unmet need across multiple types of cancer.”
Stage III lung cancer represents approximately one third of NSCLC incidence and was estimated to affect around 100,000 patients in the G7 countries in 2016, the company noted.
AstraZeneca recently received accelerated approval from the US FDA for Imfinzi in previously treated patients with advanced bladder cancer. Imfinzi is also being tested in the 1st-line treatment of patients with NSCLC as monotherapy. It is also being developed in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4, the company said.