AstraZeneca’s phase III LATIFY study, which evaluated the combination of its immunotherapy Imfinzi (durvalumab) with the investigational ATR inhibitor ceralasertib, did not meet its primary overall‑survival endpoint in patients with previously treated advanced non‑small‑cell lung cancer (NSCLC). The trial enrolled 594 patients across more than 20 countries and compared the combination to standard docetaxel chemotherapy.
The study’s primary objective was to improve overall survival (OS). While the combination achieved the secondary endpoint of progression‑free survival (PFS), OS was not improved; median survival was not reached for the combination arm and was 20.1 months for the docetaxel arm. The failure to meet the OS endpoint means the combination does not provide a survival advantage over existing therapy.
The LATIFY trial’s negative result underscores the broader challenges facing ATR inhibitors. Other candidates in the class, such as Bayer’s elimusertib and Merck KGaA’s berzosertib, have also encountered setbacks, suggesting that the mechanism may be difficult to translate into clinical benefit when combined with immunotherapy.
AstraZeneca’s executive vice‑president of oncology, Susan Galbraith, said the company remains committed to developing new medicines for lung cancer, but the outcome will shape future development plans for ceralasertib and may delay or alter its clinical trajectory. The company will continue to evaluate the drug in other indications, but the setback could impact the valuation of its oncology pipeline.
On the same day, AstraZeneca received a breakthrough therapy designation from the U.S. FDA for its HER2‑positive early breast‑cancer drug Enhertu, providing a counterbalancing positive note in the company’s oncology portfolio.
Overall, the LATIFY failure represents a significant hurdle for AstraZeneca’s lung‑cancer strategy and may prompt a reassessment of the company’s ATR‑inhibitor program, while the Enhertu designation highlights ongoing progress in other therapeutic areas. Investors will likely view the trial outcome as a negative development that could influence future pipeline valuations and strategic priorities.
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