Trial Discontinuation Details
The decision to halt the trial was based on a recommendation from an 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: progression-free survival (PFS) or overall survival (OS). This assessment specifically applied to the primary analysis population of patients with PD-L1 negative tumors (<1%) when compared to the comparator arm.
Safety Profile
AstraZeneca reported that the safety profile of volrustomig plus chemotherapy during the trial was consistent with the known profiles of the individual medicines. No new safety signals were identified.
Company Statement
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, commented on the decision.
She stated, “We initiated the eVOLVE-Lung02 trial aiming to improve the outcomes for patients whose lung cancers have lower PD-L1 expression and a less durable response to current immunotherapy regimens. 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.”
Patient Care and Ongoing Trials
The company will collaborate with investigators to ensure continuity of care and appropriate follow-up for patients enrolled in the eVOLVE-Lung02 trial. Other ongoing Phase III trials for volrustomig in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma will continue as planned.
About eVOLVE-Lung02
The eVOLVE-Lung02 trial was a randomized, open-label, multi-centre, global Phase III study. It enrolled 895 patients across 25 countries. Patients were randomized to receive either 750mg intravenous volrustomig in combination with chemotherapy or 200mg pembrolizumab plus chemotherapy.
About Volrustomig
Volrustomig is a dual checkpoint inhibitor bispecific antibody. It is designed to deliver coordinated and targeted PD-1 and CTLA-4 blockade on the same T cell. AstraZeneca is evaluating volrustomig as both monotherapy and in combinations across several tumor types with high unmet medical needs.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is a leading cause of cancer-related deaths globally, accounting for nearly one in four (23%) cancer deaths. Non-small cell lung cancer (NSCLC) represents 80-85% of all lung cancer cases. Many patients are diagnosed with metastatic disease, where the tumor has spread beyond the lung. Approximately 12% of individuals with metastatic NSCLC survive five years post-diagnosis.