Cambridge, UK — August 17, 2026
AstraZeneca announced that it is discontinuing the eVOLVE-Lung02 Phase III trial evaluating volrustomig plus chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 at less than 50%. The decision follows a planned review of trial data by the Independent Data Monitoring Committee (IDMC), which determined that the volrustomig combination was unlikely to meet either of the study’s dual primary endpoints of progression-free survival (PFS) or overall survival (OS) in the primary analysis population of patients with PD-L1-negative tumors, defined as PD-L1 expression below 1%. AstraZeneca reported that the safety profile of volrustomig plus chemotherapy remained consistent with the known profiles of the individual medicines, with no new safety signals identified.
eVOLVE-Lung02 Fails to Support Primary Endpoints
The randomized, open-label, global Phase III eVOLVE-Lung02 trial was designed to compare volrustomig plus chemotherapy with pembrolizumab plus chemotherapy, the comparator regimen, in previously untreated patients with metastatic NSCLC and PD-L1 expression below 50%. The study enrolled 895 patients across 25 countries, with participants randomized 1:1 between the treatment groups. The dual primary endpoints were PFS and OS in patients whose tumors had PD-L1 expression below 1%, while secondary endpoints included PFS and OS in the broader intent-to-treat population with PD-L1 expression below 50%. Following its planned review, the IDMC concluded that the experimental combination was unlikely to demonstrate the required benefit against the comparator in the primary analysis population. AstraZeneca therefore decided to discontinue the trial rather than continue the study toward an outcome considered unlikely to meet its predefined objectives.
Volrustomig Development Continues in Other Cancers
Despite the discontinuation of eVOLVE-Lung02, AstraZeneca will continue development of volrustomig in other Phase III programs. The company is evaluating the investigational medicine in cervical cancer, head and neck squamous cell carcinoma and mesothelioma, with those trials continuing as planned. Volrustomig is a dual checkpoint inhibitor bispecific antibody designed to provide coordinated blockade of PD-1 and CTLA-4 on the same T cell. AstraZeneca is investigating the medicine both as a monotherapy and in combination approaches across tumor types with significant unmet medical needs. The discontinuation of one lung cancer study therefore does not represent an end to the company’s broader volrustomig development program, although the negative eVOLVE-Lung02 outcome removes one clinical development path for the medicine in first-line metastatic NSCLC.
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AstraZeneca Maintains Broader Immuno-Oncology Strategy
The eVOLVE-Lung02 decision highlights the challenges involved in developing next-generation immunotherapies for metastatic NSCLC, particularly among patients with low or absent PD-L1 expression who may have less durable responses to existing immunotherapy-based treatment approaches. AstraZeneca said it will work with investigators to ensure continuity of care and appropriate follow-up for patients participating in the discontinued trial. The company continues to pursue a broad immuno-oncology strategy involving established medicines, novel checkpoint inhibitors, bispecific antibodies and other immune-based therapeutic approaches. While the eVOLVE-Lung02 results represent a setback for volrustomig in this specific lung cancer setting, AstraZeneca continues to evaluate the molecule and other immuno-oncology programs across multiple cancer types and stages of disease.
Source: AstraZeneca press relese
