AstraZeneca’s combination therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) has failed to meet the primary endpoint in a Phase III trial.
In the LATIFY trial (NCT05450692), the combination of ceralasertib and Imfinzi (durvalumab) did not improve overall survival (OS) compared with standard of care (SoC) docetaxel chemotherapy.
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The trial evaluated patients without actionable genomic alterations (AGAs) whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy. Patients were randomised to receive ceralasertib 240mg twice daily oral tablets for seven days in combination with a 1,500mg fixed dose of Imfinzi – AstraZeneca’s antibody already approved in NSCLC – every four weeks or docetaxel every three weeks until disease progression, unacceptable toxicity, withdrawal of consent or a discontinuation criterion was met.
Executive vice president of oncology haematology R&D at AstraZeneca, Susan Galbraith, 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.”
Despite the failed primary endpoint, the combination was generally well-tolerated, with a safety profile consistent with the known profiles of each individual medicine, and no new safety concerns were identified.
AstraZeneca said that the trial data will be presented at an upcoming medical meeting.
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By GlobalDataSpeaking to Clinical Trials Arena in September 2025, Biswajit Podder, PhD, oncology and haematology analyst for GlobalData, said that if the LATIFY trial had a negative outcome, it “would likely narrow ATR’s role to biomarker-selected subsets”. He also raised concern about the Phase III trial design as it did not evaluate each therapy as a monotherapy, which he said “limits attribution of benefit to ATR inhibition”.
GlobalData valued the NSCLC market in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) at $24.1bn in the 2022 base year and expects the market to reach $56.5bn by 2032 at a compound annual growth rate (CAGR) of 8.9%.
The market is expected to be dominated by PD-1/PD-L1 and CTLA-4 inhibitors, such as MSD’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab).
GlobalData is the parent company of Clinical Trials Arena.
