According to a recent Northwestern Medicine meta-analysis published in JAMA Oncology, nivolumab plus ipilimumab immunotherapy treatment was not associated with an improvement in survival for advanced malignancies other than melanoma when compared to nivolumab alone.
“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, Ph.D., associate professor of Medicine in the Division of Hematology and Oncology and of Pathology and senior author of the study.
For cancers in which nivolumab and ipilimumab combination therapy has been approved without comparison with nivolumab monotherapy, non-inferiority trials should be strongly considered. 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.
Professor Niraj Shenoy
In the current analysis, researchers looked at data from eight clinical trials that included more than 1,700 patients with various advanced cancers, such as glioblastoma multiforme, urothelial carcinoma, small cell lung cancer, squamous cell lung cancer, pleural mesothelioma, and urothelial carcinoma.
Overall, the analysis showed that nivolumab with ipilimumab therapy had no better effect on overall survival or progression-free survival than nivolumab alone. In comparison to monotherapy, the combination therapy was also linked to significantly higher levels of toxicity.
According to the authors, the results indicate that nivolumab + ipilimumab may not be necessary for individuals with advanced malignancies other than melanoma and that nivolumab monotherapy may offer comparable clinical results with less toxicity.
“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.”
