AstraZeneca has announced it is stopping its Phase III eVOLVE-Lung02 study, which was testing volrustomig combined with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (mNSCLC) in patients with PD-L1 tumour expression below 50%. The trial compared this regimen against pembrolizumab plus chemotherapy.
The decision follows guidance from an Independent Data Monitoring Committee (IDMC), which reviewed trial data on a scheduled basis and determined that the volrustomig arm was unlikely to achieve statistically meaningful improvements in either progression-free survival or overall survival — the trial’s two primary goals — among patients with PD-L1-negative tumours (below 1% expression), when measured against the comparator treatment.
Importantly, no new safety concerns emerged. The combination’s tolerability profile matched what has already been documented for each drug individually.
Susan Galbraith, the company’s Executive Vice President for Oncology Haematology R&D, expressed disappointment but framed the outcome as part of ongoing scientific learning, reaffirming AstraZeneca’s commitment to advancing its lung cancer pipeline.
Enrolling 895 patients across 25 countries, eVOLVE-Lung02 tested volrustomig — a bispecific antibody engineered to simultaneously block PD-1 and CTLA-4 pathways on T cells — against the established checkpoint inhibitor pembrolizumab. AstraZeneca confirmed that patients currently enrolled will continue receiving appropriate care and monitoring in coordination with study investigators.
Despite this setback, the company’s broader volrustomig development programme remains active, with Phase III trials continuing in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma.
Lung cancer remains the world’s deadliest cancer type, responsible for roughly 23% of all cancer-related deaths globally, with NSCLC representing the majority of diagnosed cases.
Written By: Sayan Das
Graphics by: Pramit Hazra
