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AstraZeneca Pauses Phase 3 Lung Cancer Trial as Pipeline Faces Fresh Setback

AstraZeneca Pauses Phase 3 Lung Cancer Trial as Pipeline Faces Fresh Setback
AstraZeneca halts lung cancer trial in fresh pipeline setbackProactive uses images sourced from Shutterstock

AstraZeneca has paused a phase 3 trial of Volrustomig in lung cancer after an independent committee review found it unlikely to improve survival versus existing therapies. This is the company's second recent pipeline setback following the July termination of the Wainua cardiovascular trial. Despite the halt, AstraZeneca reported positive results for Enhertu in non-small cell lung cancer and will continue testing Volrustomig in other tumor types.

AstraZeneca PLC has halted a late-stage (phase 3) trial of Volrustomig in lung cancer after an Independent Data Monitoring Committee concluded the drug, when combined with chemotherapy, was unlikely to improve overall survival compared with existing treatments.

Reason for the Halt

The decision to discontinue the trial followed a planned interim data review and a recommendation from the independent committee. The move is the company's second recent pipeline reversal, coming after July’s discontinuation of the cardiovascular drug Wainua, which erased billions from AstraZeneca’s market value.

Company Response and Next Steps

Susan Galbraith, an executive vice president at AstraZeneca, called the outcome disappointing but said the company will draw lessons from the study and remain committed to advancing its oncology pipeline. AstraZeneca said it will continue testing Volrustomig in other tumour types, including cervical cancer, head and neck squamous cell carcinoma and mesothelioma.

Mixed Clinical News

Despite the Volrustomig setback, AstraZeneca reported encouraging results for other programs. Enhertu demonstrated a statistically significant and clinically meaningful delay in disease progression for patients with non-small cell lung cancer and will advance into a phase 3 trial. Separately, late-stage data for Tagrisso in combination with Orpathys reinforced Tagrisso’s role as a backbone therapy for another lung cancer subtype.

Market Reaction and Analyst View

Shares in AstraZeneca rose as much as 2% in early trading amid the mixed clinical updates. Axel Rudolph, chief technical analyst at IG, noted the Volrustomig halt highlights the clinical and commercial risks that can affect AstraZeneca’s growth story, while also observing that the company’s fundamentals and late-stage pipeline remain robust.

The company said it remains focused on learning from each study and advancing promising candidates across its oncology portfolio.

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