Update on PEARL phase III trial of Imfinzi monotherapy in stage IV non-small cell lung cancer

There was an improvement in OS with Imfinzi monotherapy, which was clinically meaningful in the subset of patients with PD-L1 tumour expression greater than 50%, a secondary endpoint. The trial was conducted primarily in Asia.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “With PEARL, we set out to answer important scientific questions in the treatment of metastatic non-small cell lung cancer at a time when patient selection for immune checkpoint inhibitors was still evolving. We are encouraged to see patients in the metastatic setting at a higher level of PD-L1 tumour expression demonstrate the most benefit with Imfinzi monotherapy treatment, as is commonly seen in this class. We remain steadfast in our dedication to developing new and improved medicines and regimens for patients with lung cancer across our diverse portfolio.”

The safety and tolerability profile for Imfinzi was broadly consistent with the known profile of the medicine, and no new safety signals were identified. The data will be shared in due course.

PEARL study : PEARL was a randomised, open-label, multicentre, global Phase III trial of Imfinzi monotherapy versus platinum-based chemotherapy (investigator’s choice) as a 1st-line treatment in patients with metastatic NSCLC. Eligible patients had tumours expressing high levels of PD-L1, defined as greater than 25% of tumour cells (TC). The predominantly Asian trial population included both smokers and non-smokers and patients of squamous and non-squamous histology. PEARL excluded patients with certain epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions.The two primary endpoints were OS in patients whose tumours expressed high levels of PD-L1 (TC?25%) and OS in a subgroup of patients identified as being at low risk of early mortality using a model developed by AstraZeneca that evaluates various clinical parameters prior to treatment. The trial included centres in Asia, Europe and Australia.