AstraZeneca is discontinuing a Phase III trial testing its immunotherapy drug volrustomig in combination with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer (mNSCLC), after an independent review found the regimen was unlikely to deliver the trial’s key benefits.

 

The decision follows a planned review by the Independent Data Monitoring Committee (IDMC), which concluded that volrustomig plus chemotherapy was unlikely to meet either of the trial’s dual primary endpoints — progression-free survival (PFS) or overall survival (OS) — in patients whose tumours were PD-L1 negative, defined as expression below 1%.

 

The eVOLVE-Lung02 trial was comparing the volrustomig combination with pembrolizumab plus chemotherapy in patients with mNSCLC whose tumours had PD-L1 expression below 50%.

 

Despite the setback, AstraZeneca said the safety profile of volrustomig combined with chemotherapy remained consistent with the known safety profiles of the individual medicines, with no new safety signals identified.

 

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.”

 

AstraZeneca said it will work with investigators to ensure patients enrolled in the trial receive continuity of care and appropriate follow-up.

 

The company’s broader development programme for volrustomig remains on track, with other Phase III trials continuing in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.