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Update on LATIFY Phase III trial of ceralasertib
AstraZeneca announced that the LATIFY Phase III trial of ceralasertib in combination with Imfinzi did not meet its primary endpoint of overall survival in patients with previously treated advanced non-small cell lung cancer. The trial, which enrolled 594 patients across more than 20 countries, evaluated the combination against standard-of-care docetaxel in patients whose disease progressed after prior immunotherapy and chemotherapy. While the combination was generally well tolerated with no new safety concerns, this outcome represents a setback for the development of ceralasertib in this specific patient population. Disclaimer*
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n22 Dec 2025\nUpdate on LATIFY Phase III trial of ceralasertib plus Imfinzi in\npreviously treated advanced non-small cell lung cancer\n \nThe LATIFY Phase III trial of ceralasertib in combination with Imfinzi (durvalumab) did not meet the primary endpoint of overall survival (OS) versus standard-of-care docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The trial evaluated patients without actionable genomic alterations (AGAs) whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy.\n \nSusan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: \"Our goal in the LATIFY trial was to reinvigorate the immune response of patients with lung cancer whose tumours stopped responding to available therapies by combining ATR inhibition with immunotherapy. While we are disappointed by this result, we remain committed to pioneering new medicines to address the urgent need to improve outcomes for patients with lung cancer through our industry-leading portfolio.\"\n \nThe combination of ceralasertib and Imfinzi was generally well tolerated, and the safety profile was consistent with the known profiles of each individual medicine, with no new safety concerns identified. These data will be presented at a forthcoming medical meeting.\n \nNotes\nNSCLC\nLung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into small cell lung cancer (SCLC) or NSCLC, the latter accounting for about 80-85% of cases.2-3 Patients are most commonly diagnosed with metastatic disease, when the tumour has spread outside the lung.4 Approximately 12% of people with metastatic NSCLC will still be alive five years after diagnosis.5\nLATIFY\nLATIFY is a randomised, open-label, multi-centre, global Phase III trial of ceralasertib plus Imfinzi in patients with locally advanced or metastatic NSCLC without AGAs, and whose disease has progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Patients were randomised 1:1 to receive ceralasertib 240mg twice daily oral tablets for seven days in combination with a 1,500mg fixed dose of Imfinzi on day eight every four weeks or docetaxel every three weeks until disease progression...