AstraZeneca discontinued its Phase III eVOLVE-Lung02 trial of volrustomig plus chemotherapy in metastatic non-small cell lung cancer after an independent committee found the combination unlikely to meet dual primary endpoints. The trial enrolled 895 patients across 25 countries. Shares fell 2.12 percent.
AstraZeneca halted its Phase III volrustomig lung cancer trial after an independent committee found the combination unlikely to meet dual primary endpoints.
"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," Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca, said.
The randomized, open-label, multi-centre trial enrolled 895 patients across 25 countries, randomizing them 1:1 to receive 750mg intravenous volrustomig plus chemotherapy every three weeks for four cycles, followed by volrustomig alone, or 200mg pembrolizumab (Keytruda) plus chemotherapy for four cycles, followed by pembrolizumab until 24 months of treatment or disease progression. The Independent Data Monitoring Committee concluded the volrustomig combination was unlikely to achieve progression-free survival or overall survival benefits in patients with PD-L1-negative tumors (<1%). The safety profile was consistent with known profiles of the individual medicines, with no new safety signals identified.
Shares of AstraZeneca fell 2.12 percent after the announcement. The company will work with investigators to ensure continuity of care for enrolled patients. Other Phase III volrustomig trials continue in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma.
Lung cancer is the leading cause of cancer death globally, accounting for nearly one in four (23 percent) cancer deaths. Non-small cell lung cancer represents 80-85 percent of cases, and approximately 12 percent of patients with metastatic disease survive five years after diagnosis. The eVOLVE-Lung02 trial targeted patients with PD-L1 expression below 50 percent, a population that derives less durable benefit from standard immunotherapy.
Volrustomig is a dual checkpoint inhibitor bispecific antibody designed to deliver coordinated PD-1 and CTLA-4 blockade on the same T cell. AstraZeneca is evaluating the drug as monotherapy and in combinations across several tumor types with high unmet need. The dual primary endpoints were progression-free survival and overall survival in patients whose tumors express PD-L1 <1%. Secondary endpoints included PFS and OS in the intent-to-treat population (PD-L1 <50%).
The termination removes a potential first-line option for the roughly half of metastatic NSCLC patients with low PD-L1 expression who derive less durable benefit from current immunotherapy regimens. Investors will watch the remaining volrustomig Phase III readouts in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma for signs of whether the bispecific platform can still deliver.
This article is for informational purposes only and does not constitute investment advice.
