AstraZeneca (LSE:AZN) announced it is discontinuing the eVOLVE-Lung02 Phase III trial, which tested volrustomig plus chemotherapy against pembrolizumab plus chemotherapy in metastatic non-small cell lung cancer patients with lower PD-L1 tumour expression.
The Independent Data Monitoring Committee made the call after a planned review found the volrustomig combination unlikely to meet either progression-free survival or overall survival endpoints against the comparator arm in patients with PD-L1 negative tumours.
The trial had enrolled 895 patients across 25 countries, randomising them to volrustomig or pembrolizumab regimens alongside chemotherapy.
No new safety signals emerged, with volrustomig's safety profile matching that of the individual medicines already known.
"While we are disappointed, we will learn from this trial and are determined to continue pioneering new medicines from our industry-leading pipeline in our quest to improve outcomes for patients with lung cancer," said Susan Galbraith, AstraZeneca's Executive Vice President of Oncology Haematology R&D.
Volrustomig is a bispecific antibody designed to block both PD-1 and CTLA-4 on the same T cell.
AstraZeneca's other Phase III trials of the drug continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.
The company will work with trial investigators to ensure continuity of care for patients enrolled in eVOLVE-Lung02.
News Intelligence what this means for the company
AstraZeneca halted its Phase III eVOLVE-Lung02 trial of volrustomig after an independent monitoring committee determined the drug plus chemotherapy was unlikely to beat pembrolizumab plus chemotherapy on survival in PD-L1 negative lung cancer patients. The trial enrolled 895 patients across 25 countries; no new safety signals emerged. This is a setback for volrustomig in lung cancer, but the company's other Phase III trials of the bispecific antibody in cervical cancer, head and neck squamous cell carcinoma and mesothelioma continue.
Volrustomig's failure in this lung cancer indication removes one near-term catalyst from AstraZeneca's oncology pipeline, though the drug remains in development across three other cancer types. Against first-half 2026 revenue of $30.67bn, this single trial discontinuation does not materially alter the company's development trajectory, but it underscores execution risk in a pipeline-dependent business.
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