AstraZeneca discontinues eVOLVE Lung02 Phase III trial of volrustomig plus chemotherapy in metastatic non small cell lung cancer

AstraZeneca has decided to stop the eVOLVE Lung02 Phase III trial, which was evaluating volrustomig combined with chemotherapy as a first line therapy against pembrolizumab plus chemotherapy in patients with metastatic non small cell lung cancer whose tumors show PD-L1 expression below 50 percent.

The decision follows a recommendation from the trial’s Independent Data Monitoring Committee after a scheduled review of the data collected so far. The committee determined that the volrustomig combination was unlikely to achieve either of the trial’s two primary goals, progression free survival or overall survival, within the main analysis group of patients whose tumors were PD-L1 negative (below 1 percent), when measured against the comparator treatment arm.

The combination of volrustomig and chemotherapy showed a safety profile in line with what is already known about each medicine individually, and no new safety concerns were identified during the trial.

Susan Galbraith, executive vice president of oncology haematology research and development at AstraZeneca, said the eVOLVE Lung02 trial had been launched with the goal of improving outcomes for patients whose lung cancers show lower PD-L1 expression and tend to respond less durably to existing immunotherapy approaches. She acknowledged disappointment with the outcome but said the company would apply what it learned from the trial and remains committed to advancing new treatments from its pipeline in pursuit of better outcomes for lung cancer patients.

AstraZeneca will coordinate with trial investigators to ensure patients continue receiving appropriate care and follow up. The company’s other Phase III trials of volrustomig, covering cervical cancer, head and neck squamous cell carcinoma, and mesothelioma, remain on track and are continuing as planned.

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Related Topics and Keywords

AstraZeneca, chemotherapy, eVOLVE Lung02 Phase III trial, lung cancer, metastatic non-small cell lung cancer, volrustomig