Phase 3 eVOLVE-Lung02 Trial of Novel Bispecific in NSCLC Halted

AstraZeneca is discontinuing the phase 3 eVOLVE-Lung02 trial (NCT05984277) evaluating volrustomig (MEDI5752) plus chemotherapy vs pembrolizumab (Keytruda) plus chemotherapy as first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 <50%.¹

The decision follows a recommendation from the trial's independent data monitoring committee (IDMC), which determined during a planned review of trial data that the volrustomig combination was unlikely to meet either of the study's dual primary end points of progression-free survival (PFS) or overall survival (OS) vs the pembrolizumab arm in the primary analysis population of patients with PD-L1–negative tumors (<1%).

The safety profile of volrustomig plus chemotherapy was consistent with the known profiles of the individual agents, and no new safety signals were identified.

"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,” said Susan Galbraith, executive vice president, Oncology Hematology Research and Development, AstraZeneca, said in a news release.

About the eVOLVE-Lung02 Trial

eVOLVE-Lung02 is a randomized, open-label, multicenter, global phase 3 trial evaluating volrustomig plus chemotherapy as first-line treatment for patients with mNSCLC whose tumors express PD-L1 <50%^.1,2 Patients were randomized 1:1 to receive intravenous volrustomig at 750 mg plus chemotherapy every 3 weeks for 4 cycles followed by volrustomig every 3 weeks, or pembrolizumab at 200 mg plus chemotherapy every 3 weeks for 4 cycles followed by pembrolizumab every 3 weeks, until completion of 24 months of treatment, disease progression, or another discontinuation criterion was met.¹

The trial enrolled 895 patients across 25 countries.^1,2 The dual primary end points were PFS and OS in patients with PD-L1–negative tumors (<1%); secondary end points included PFS and OS in the intent-to-treat population with PD-L1 <50%.

About Volrustomig

Volrustomig is a dual checkpoint inhibitor bispecific antibody designed to deliver coordinated, targeted PD-1 and CTLA-4 blockade on the same T cell. AstraZeneca is evaluating volrustomig as monotherapy and in combination across several tumor types with high unmet need, including ongoing phase 3 trials in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma. The phase 3 volrustomig trials in these tumor types will continue as planned.

REFERENCES

1. Update on eVOLVE-Lung02 Phase III trial of volrustomig plus chemotherapy in metastatic non-small cell lung cancer. News release. AstraZeneca. August 17, 2026. Accessed August 18, 2026. https://tinyurl.com/5a6aa5w5

2. A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. (eVOLVE-Lung02). ClinicalTrials.gov. Updated July 28, 2026. Accessed August 18, 2026. https://clinicaltrials.gov/study/NCT05984277