17th Aug 2026 09:43
(Alliance News) - AstraZeneca PLC on Monday announced it is discontinuing the eVOLVE-Lung02 phase III trial after an independent review found its experimental drug volrustomig was unlikely to improve outcomes against the comparator treatment.
The Cambridge, England-based pharmaceutical company said the decision followed a planned review by the trial's independent data monitoring committee, which concluded the combination "was unlikely to meet either of the dual primary endpoints of progression-free survival or overall survival".
The trial was evaluating volrustomig with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer.
No new safety signals were identified, and AstraZeneca said it would work with investigators to ensure continuity of care and follow-up for trial patients. Other phase III trials of volrustomig in cervical cancer, head and neck squamous cell carcinoma and mesothelioma will continue as planned.
Susan Galbraith, AstraZeneca's executive vice president of Oncology Haematology R&D, said: "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."
Separately, AstraZeneca said its Saffron phase III trial of Tagrisso plus Orpathys showed statistically significant and clinically meaningful improvements in progression-free survival and overall survival in patients with a form of non-small cell lung cancer whose tumours had high levels of MET overexpression or amplification.
Overall survival is the length of time from the start of treatment until death, while progression-free survival measures how long a patient lives without their disease worsening.
Galbraith said: "By combining Orpathys and Tagrisso, with its established efficacy, safety profile and central nervous system protection, we aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe."
"This further strengthens our leadership in EGFR-mutated lung cancer, reinforcing our strategy to improve patient outcomes across stages and through lines of therapy with novel combinations," she added.
Hutchmed China Ltd, which jointly develops Orpathys with AstraZeneca, also announced the Saffron results, saying the trial was the first global phase III study to show significant progression-free and overall survival benefits in this setting.
In another statement, AstraZeneca said its Enhertu treatment had demonstrated a "statistically significant and clinically meaningful" improvement in progression-free survival in the Destiny-Lung04 phase III trial. The trial is evaluating Enhertu as a first-line treatment for patients with HER2-mutant advanced non-small cell lung cancer against the global standard of care.
AstraZeneca said HER2-mutant lung cancer can often affect younger patients and has historically had limited first-line targeted treatment options.
Shares in AstraZeneca were up 1.2% at 11,598.00 pence on Monday morning in London.
By Niall Holden, Alliance News reporter
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