(RTTNews) - British drug major AstraZeneca Plc (AZN, AZN.L) announced Monday that it is discontinuing the eVOLVE-Lung02 Phase III trial of volrustomig plus chemotherapy in metastatic non-small cell lung cancer or mNSCLC, based on the recommendation of the Independent Data Monitoring Committee.
The company would work with investigators to ensure continuity of care and appropriate follow up for patients on the trial, which enrolled 895 patients across 25 countries.
Meanwhile, the other Phase III volrustomig trials continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.
Volrustomig is a dual checkpoint inhibitor bispecific antibody for coordinated and targeted PD-1 and CTLA-4 blockade on the same T cell. AstraZeneca is evaluating volrustomig as monotherapy and in combinations in several tumour types with high unmet need.
AstraZeneca noted that the randomized, open-label, multi-centre, global eVOLVE-Lung02 Phase III trial was evaluating volrustomig in combination with chemotherapy as a 1st-line therapy compared to pembrolizumab and chemotherapy in patients with mNSCLC whose tumours express PD-L1 50%.
According to the firm, Independent Data Monitoring Committee or IDMC, following a planned review of trial data, concluded that the volrustomig combination was unlikely to meet either of the dual primary endpoints of progression-free survival or overall survival in the primary analysis population of patients with PD-L1 negative tumours (1%) versus the comparator arm.
The safety profile of volrustomig plus chemotherapy was consistent with the known profiles of the individual medicines and no new safety signals were identified.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said, "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."
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