A combination immunotherapy treatment of nivolumab plus ipilimumab was associated with no improvement in survival for advanced cancers other than melanoma, when compared to nivolumab alone, according to a recent Northwestern Medicine meta-analysis published in JAMA Oncology.
“This meta-analysis revealed that in advanced cancers other than melanoma, the addition of ipilimumab to standard-dose nivolumab was not associated with a clinically meaningful improvement in overall survival or progression-free survival, while substantially increasing high-grade toxicities. Oncologists will hopefully consider these data carefully, along with the specific disease context, before prescribing or recommending addition of ipilimumab to standard-dose nivolumab in a non-melanoma advanced cancer,” said Niraj Shenoy, MD, PhD, associate professor of Medicine in the Division of Hematology and Oncology and of Pathology and senior author of the study.
In the current analysis, investigators examined data from eight clinical trials that covered more than 1,700 patients with different advanced cancers, including non–small cell lung cancer, small cell lung cancer, squamous cell lung cancer, pleural mesothelioma, urothelial carcinoma, esophagogastric carcinoma, sarcoma and glioblastoma multiforme.
Overall, the analysis revealed that treatment with nivolumab plus ipilimumab was not associated with improvement in overall or progression-free survival compared to nivolumab alone. The combination treatment was also associated with substantially higher toxicity compared to the monotherapy.
The findings suggest that nivolumab plus ipilimumab may be unnecessary for patients with advanced cancers other than melanoma, and that nivolumab monotherapy may provide similar clinical outcomes with reduced toxicity, according to the authors.
“For cancers in which nivolumab and ipilimumab combination therapy has been approved without comparison with nivolumab monotherapy, non-inferiority trials should be strongly considered,” Shenoy said. “The meta-analysis serves as a sobering reminder to the oncology research community as well as regulatory bodies to refrain from assuming combinatorial superiority across cancers based on data in one cancer.”
Anthony Serritella, MD, a clinical fellow in the Department of Medicine’s Hematology and Medical Oncology Fellowship Program, was a co-author of the study.
Shenoy is a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. His work is supported by the American Cancer Society, the Division of Hematology and Oncology at the Northwestern University Feinberg School of Medicine, and the Lotte and John Hecht Memorial Foundation.
