AstraZeneca is discontinuing the Phase III eVOLVE-Lung02 trial, which evaluated volrustomig plus chemotherapy as first-line treatment compared with pembrolizumab plus chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 <50%.
The decision was based on a recommendation from the Independent Data Monitoring Committee (IDMC) following a planned review of trial data. The IDMC concluded that the volrustomig combination was unlikely to meet either of the dual primary endpoints of progression-free survival (PFS) or overall survival (OS) in the primary analysis population of patients with PD-L1-negative tumors (<1%) versus the comparator arm.
AstraZeneca reported that the safety profile of volrustomig plus chemotherapy was consistent with the known profiles of the individual medicines, with no new safety signals identified.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, said the trial was initiated with the aim of improving outcomes for patients with lower PD-L1 expression and less durable responses to current immunotherapy regimens. She added:
“While we are disappointed, we will learn from this trial and are determined to continue pioneering new medicines from our industry-leading pipeline in our quest to improve outcomes for patients with lung cancer.”
AstraZeneca said it will work with investigators to ensure continuity of care and appropriate follow-up for patients participating in the trial. Other Phase III trials of volrustomig in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma will continue as planned.
https://oncodaily.com/trial-updates/astrazeneca-evolve-lung02-568154
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