Volrustomig

AstraZeneca is ending a Phase III study of volrustomig in metastatic non–small-cell lung cancer (NSCLC) after a planned review concluded that the trial is unlikely to meet either of its primary endpoints of progression-free survival (PFS) or overall survival (OS). 'While we are disappointed, we will learn from this trial," said Susan Galbraith, EVP of oncology haematology R&D.The eVOLVE-Lung02 study enrolled 895 patients with metastatic NSCLC whose tumours express PD-L1 <50%. Participants were randomised to receive first-line treatment with volrustomig — a bispecific antibody targeting PD-1 and CTLA-4 — or Merck & Co.'s Keytruda (pembrolizumab), both in combination with chemotherapy. AstraZeneca noted that after looking at the trial data, the Independent Data Monitoring Committee (IDMC) determined that the volrustomig combination was unlikely to achieve its PFS and OS main goals in the primary analysis population of patients with PD-L1 negative tumours (<1%) versus the Keytruda combination arm. The company added that volrustomig's safety was consistent with its known profile and no new safety signals were identified.Volrustomig is also being investigated in Phase III studies for cervical cancer, head and neck squamous cell carcinoma and mesothelioma, which AstraZeneca said will continue as planned. While the drug, if approved, is forecast to bring in sales of around $1.3 billion by 2032, Jefferies analysts had called it a "long shot."

iStock, Nuthawut Somsuk AstraZeneca will push through with its other Phase 3 studies for volrustomig, including in cervical cancer and mesothelioma. AstraZeneca will discontinue a Phase 3 study for its investigational bispecific antibody volrustomig in non-small cell lung cancer following disappointing interim data. The pharma was testing volrustomig in the late-stage eVOLVE-Lung02 trial in combination with chemotherapy as a first-line treatment option for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression levels lower than 50%. The study compared the volrustomig regimen against Merck’s Keytruda plus chemotherapy. A planned review of the trial data showed that volrustomig was unlikely to hit either of the study’s primary endpoints of progression-free survival or overall survival, according to a Monday morning release . Thus, the independent data panel recommended the study’s termination. AstraZeneca did not provide specific data in its release. The pharma is “disappointed” with the results, Susan Galbraith, executive vice president of Oncology Hematology R&D, said in a prepared statement, adding that the company “will learn from this trial.” AstraZeneca will continue its other Phase 3 volrustomig studies as planned in mesothelioma, cervical cancer, and head and neck squamous cell carcinoma. The latest blow continues what has been a rough few months for AstraZeneca in the clinic. Most notably, the pharma last month announced that its antisense therapy Wainua, which it shares with Ionis Pharmaceuticals, failed to show significant cardiovascular benefit in a Phase 3 study transthyretin amyloidosis-cardiomyopathy (ATTR-CM) study. The stumble sent waves across the ATTR-CM space, casting doubt on the silencer class of therapies—which work by suppressing transthyretin expression—and giving a boost to stabilizers, which prevent the protein from misfolding, a crucial pathogenic step. Cardiovascular disease AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics. July 10, 2026 · 3 min read · Tristan Manalac Read more Aside from Wainua, AstraZeneca also revealed in July that its rare disease drug Ultomiris failed to achieve statistically significant event-free survival in the Phase 3 ALXN1210-TMA-313 trial, which enrolled patients 12 years and older with thrombotic microangiopathy who had received hematopoietic stem cell transplant. That same day, during its second quarter earnings report , the pharma disclosed some other clinical disappointments, including in the Phase 3 CLARITY-Gastric01 trial, where its antibody-drug conjugate sonesitatug vedotin failed to significantly boost progression-free survival in the overall study population of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. The asset did improve overall survival in these patients. Earnings AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure AstraZeneca remains “very much on track” to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said during the company’s Q2 earnings presentation on Monday. July 27, 2026 · 3 min read · Tristan Manalac Read more Even in the case of a clinical win, AstraZeneca can’t seem to catch a break. In June, its investigational GLP-1 pill elecoglipron demonstrated a nearly 10% weight reduction at 25 weeks as compared with placebo. At 36 weeks, placebo-adjusted weight loss increased to 11.5%. While BMO Capital Markets at the time said these data pointed to elecoglipron’s “promising efficacy,” the firm added that the results were otherwise “relatively underwhelming,” especially compared with other drugs in development—particularly Structure Therapeutics’ aleniglipron, which showed a 15.3% placebo-adjusted weight reduction at 36 weeks .