AstraZeneca halts Phase III lung cancer trial after data review

AstraZeneca (NASDAQ: AZN) is discontinuing its eVOLVE-Lung02 Phase III clinical trial evaluating volrustomig in combination with chemotherapy as a first-line therapy for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 below 50%.

The decision follows a recommendation from the Independent Data Monitoring Committee (IDMC) after 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 or overall survival — in the primary analysis population of patients with PD-L1 negative tumors, compared to the pembrolizumab and chemotherapy arm.

The company said 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: "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."

AstraZeneca said it will work with investigators to ensure continuity of care for patients currently enrolled in the trial. Three other Phase III volrustomig trials, evaluating the drug in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma, will continue as planned.

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