AstraZeneca (AZ) has terminated the Phase III eVOLVE-Lung02 trial evaluating volrustomig, a PD-1×CTLA-4 bispecific antibody (BsAb), plus chemotherapy versus pembrolizumab plus chemotherapy in first-line metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression below 50% (n=895). The independent data monitoring committee concluded that in the PD-L1-negative (<1%) co-primary population, the volrustomig regimen was unlikely to meet either progression-free survival (PFS) or overall survival (OS) endpoints, while no new safety signals were observed beyond the known profile of the agent and chemotherapy.

The company confirmed the other three Phase III programmes for volrustomig in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma remain on track, and noted the setback sits alongside recent positive readouts for Tagrisso plus Orpathys and Enhertu in lung settings.