HQ Team
August 17, 2026: AstraZeneca has stopped an end-phase trial for its experimental lung cancer drug, volrustomig, after data showed the combination therapy failed to outperform standard treatments for advanced non-small cell lung cancer.
Despite the setback in this 895-patient study, the pharmaceutical company stated that development of the “two-in-one” immunotherapy—designed to block cancer camouflage signals—continues for other cancer types.
The phase III trial evaluated volrustomig in combination with chemotherapy as a first-line therapy compared to pembrolizumab and chemotherapy in patients with metastatic non-small cell lung cancer (mNSCLC) whose tumours express PD-L1 of less than 50%.
“AstraZeneca is discontinuing the trial,” according to a company statement. The safety profile of volrustomig plus chemotherapy was consistent with the known profiles of the individual medicines and no new safety signals were identified.
Independent Data Monitoring Committee
“This decision is based on the recommendation of the 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 of progression-free survival (PFS) or overall survival (OS) in the primary analysis population of patients with PD-L1 negative tumours (less than 1%) versus the comparator arm.”
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.”
The company will work with investigators to ensure continuity of care and appropriate follow-up for patients on the trial. “The other Phase III volrustomig trials continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.”
The drugmaker is expected to unveil 20 new cancer and rare therapies this year. Separately, the company reported positive results from two other late-stage lung cancer trials, with its Tagrisso-Orpathys combination and the Daiichi Sankyo-partnered Enhertu both meeting key goals.
Progression-free survival
Lung cancer is the leading cause of death by cancer globally, accounting for almost one in four (23%) cancer deaths. Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.
Patients are most commonly diagnosed with metastatic disease, when the tumour has spread outside the lung. Approximately 12% of people with metastatic NSCLC will still be alive five years after diagnosis.
The trial enrolled 895 patients across 25 countries. The dual primary endpoints were progression-free survival (PFS) and overall survival (OS) in patients whose tumours express PD-L1 of less than 1%. Secondary endpoints included PFS and OS in the intent-to-treat population or patients with PD-L1 less than 50%.
AstraZeneca is based in Cambridge in the United Kingdom. The company’s medicines are sold in more than 125 countries.
