Positive results for Imfinzi (durvalumab) from Phase III PACIFIC trial for sequential treatment of locally-advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC) .-AstraZeneca

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

A planned interim analysis conducted by an Independent Data Monitoring Committee (IDMC) concluded that the trial has already met a primary endpoint by showing statistically-significant and clinically-meaningful PFS, as assessed by blinded independent central review, in patients receiving Imfinzi compared to placebo. The results also demonstrate a favourable benefit/risk profile. The trial will also evaluate overall survival (OS), the other primary endpoint, which will be assessed in due course as specified by the protocol. AstraZeneca plans to submit the initial results from the PACIFIC trial for presentation at a forthcoming medical meeting.

Comment: AstraZeneca recently received accelerated approval from the 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 in the MYSTIC and PEARL Phase III trials. It is also being developed in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4, as part of the MYSTIC, NEPTUNE and POSEIDON Phase III trials.