AstraZeneca halts eVOLVE-Lung02 trial of volrustomig in lung cancer

AstraZeneca announced on 17 August 2026 that it is stopping the eVOLVE-Lung02 Phase III trial, which had been testing volrustomig combined with chemotherapy as a first-line treatment against pembrolizumab plus chemotherapy in patients with metastatic non-small cell lung cancer whose tumors have PD-L1 expression below 50%.¹

The company said the decision followed input from an outside safety monitoring group. This decision is based on the recommendation of the Independent Data Monitoring Committee (IDMC) following a planned review of trial data.¹ That committee determined that the volrustomig combination was unlikely to meet either of the dual primary endpoints, progression-free survival or overall survival, among patients whose tumors had PD-L1 expression under 1%, when compared with the pembrolizumab arm.¹

On safety, the company reported that the profile of volrustomig plus chemotherapy matched what was already known about the individual drugs, with no new safety concerns identified.¹

The trial had been designed as a randomized, open-label, global study, and it enrolled 895 patients across 25 countries.¹ Under the trial's design, the dual primary endpoints were progression-free survival and overall survival in patients whose tumors expressed PD-L1 below 1%.¹ Secondary endpoints looked at PFS and OS across the broader intent-to-treat population, defined as PD-L1 below 50%.¹

AstraZeneca said it will continue supporting patients already enrolled. The company will work with investigators to ensure continuity of care and appropriate follow up for patients on the trial.¹ Other studies of the drug are not affected: the other Phase III volrustomig trials continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.¹

Volrustomig is described by the company as a dual checkpoint inhibitor bispecific antibody designed to deliver coordinated and targeted PD-1 and CTLA-4 blockade on the same T cell.¹