Business
Update on Imfinzi PEARL trial
Update on Imfinzi PEARL trial.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 19 December 2022 07:05 GMT\n \n \n \n \n \n \n \n \n Update on PEARL Phase III trial of Imfinzi monotherapy\n \n \n \n \n in Stage IV non-small cell lung cancer\n \n \n \n \n \n \n \n \n The PEARL Phase III trial for AstraZeneca's Imfinzi (durvalumab) did not achieve statistical significance for the primary endpoints of improving overall survival (OS) versus platinum-based chemotherapy as a monotherapy treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC) whose tumour cells express high levels (25% or more) of PD-L1, or in a subgroup of patients at low risk of early mortality. 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.\n \n \n \n \n \n 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.\"\n \n \n \n \n \n The safety and tolerability profile for Imfinzi was broadly consistent with the known profile of the medicine, and no new safety signals were identified.\n The data will be shared in due course.\n \n \n \n \n \n \n Notes\n \n \n \n \n \n \n \n \n \n Stage IV NSCLC\n \n \n \n Lung cancer is the second most common form of cancer globally, with more than two million patients diagnosed in 2020.1 Lung cancer is broadly split into NSCLC and small-cell lung cancer (SCLC), with 80-85% classified as NSCLC.2,3 Within NSCLC, patients are classified as squamous, representing 25-30% of patients, or non-squamous, representing approximately 70-75% of patients.3-5\n \n \n \n \n \n \n PEARL\n \n \n \n PEARL was a randomised, open-label, multicentre, global Phase III trial of Imfinzi mo...