Key Takeaways
- The eVOLVE-Lung02 trial was halted due to lack of efficacy of volrustomig plus chemotherapy compared to pembrolizumab and chemotherapy.
- No new safety concerns were reported; the safety profile of volrustomig remained consistent with existing data.
- The setback raises questions for AstraZeneca’s oncology pipeline, although positive results were reported from two other lung cancer studies.
Trial Results
The eVOLVE-Lung02 trial evaluated whether volrustomig combined with chemotherapy could outperform the standard treatment of pembrolizumab and chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) and low PD-L1 expression. The Independent Data Monitoring Committee (IDMC) recommended discontinuing the trial upon reviewing data that indicated the experimental regimen was unlikely to meet its primary endpoints of progression-free survival (PFS) or overall survival (OS).
This assessment was concentrated on patients with PD-L1 negative tumors, where the expression of PD-L1 was below 1%. Importantly, AstraZeneca reported no new safety issues, affirming that the safety profile of volrustomig plus chemotherapy aligns with what is already known for both treatments.
About Volrustomig
Volrustomig is a bispecific antibody targeting two immune checkpoints, PD-1 and CTLA-4, in a single T cell, aiming to boost immune responses against tumors, particularly those with low PD-L1 expression that respond poorly to existing treatments. The global eVOLVE-Lung02 trial involved 895 patients across 25 countries, allocating them to receive either 750 mg of volrustomig or 200 mg of pembrolizumab alongside chemotherapy.
Impact on AstraZeneca’s Pipeline
The trial’s termination is significant for AstraZeneca, given that lung cancer constitutes a major sector of its oncology business, with NSCLC making up approximately 80–85% of lung cancer cases. The company is currently facing a series of challenges, including failures in other drug trials and regulatory hurdles that have raised concerns about its ability to sustain future growth.
Despite these setbacks, AstraZeneca reported positive outcomes from two additional late-stage lung cancer trials involving Tagrisso/Orpathys and Enhertu.
Future Directions
Moving forward, AstraZeneca is committed to supporting the patients involved in the eVOLVE-Lung02 trial while continuing other Phase III studies of volrustomig in different cancers such as cervical, head and neck squamous cell carcinomas, and mesothelioma. The company will need to determine whether volrustomig’s dual-checkpoint strategy can yield significant clinical benefits in future trials, raising current stakes in its ongoing Phase III programs.
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