AstraZeneca Ends Phase Three Lung Cancer Drug Trial After Review — Update

By Michael Hennessey

AstraZeneca said it is ending the Phase 3 trial of volrustomig plus chemotherapy for metastatic non-small-cell lung cancer.

The Cambridge-based pharmaceutical company said Monday that the decision is based on the recommendation of the Independent Data Monitoring Committee after a planned review of trial data.

The committee concluded that the volrustomig combination was unlikely to reach either of the primary endpoints for the drug in the eVolve-Lung02 trial.

The primary endpoints were for progression-free survival and overall survival in the primary population of patients versus the comparator arm.

AstraZeneca noted that the safety profile of the combination was consistent with the individual medicines, and no new safety signals were found.

"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," said Susan Galbraith, executive vice president, oncology hematology R&D.

The other Phase 3 volrustomig trials will continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.

Separately, AstraZeneca said Tagrisso plus Orpathys showed a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival in a Phase 3 trial in patients with epidermal growth factor receptor-mutated non-small-cell lung cancer.

The safety profile for Tagrisso plus Orpathys, or osimertinib and savolitinib, was consistent with the known profiles of each medicine, it said.

The company said this was the first global Phase 3 trial to show significant progression-free and overall survival benefits in this setting.

Tagrisso plus Orpathys is being jointly developed with Hutchmed, but is being solely commercialized by AstraZeneca.

AstraZeneca also said a Phase 3 trial of Enhertu showed a significant and clinically meaningful improvement in progression-free survival as a treatment for unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small-cell lung cancer.

AstraZeneca said Enhertu, or trastuzumab deruxtecan, has become the first and only HER2-directed medicine to improve progression-free survival over the global standard of care in a Phase 3 trial in this setting.

Enhertu is an antibody drug conjugate discovered by Japan's Daiichi Sankyo, which is being jointly developed with the British company.

Shares in AstraZeneca were up 1.2% at 115.98 pounds in London during European morning trading.

Write to Michael Hennessey at michael.hennessey@wsj.com

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August 17, 2026 05:26 ET (09:26 GMT)