AstraZeneca says PEARL trial didn’t achieve statistical significance on endpoint

The PEARL Phase III trial for AstraZeneca’s Imfinzi did not achieve statistical significance for the primary endpoints of improving overall survival versus platinum-based chemotherapy as a monotherapy treatment of patients with Stage IV non-small cell lung cancer, or NSCLC, whose tumor cells express high levels of PD-L1, or in a subgroup of patients at low risk of early mortality, the company announced. "There was an improvement in OS with Imfinzi monotherapy, which was clinically meaningful in the subset of patients with PD-L1 tumor expression greater than 50%, a secondary endpoint. The trial was conducted primarily in Asia," the company added. 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 company stated: "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."