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.
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.
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.
