FDA Accepts sBLA for Nivolumab Plus Ipilimumab for Subgroup of Advanced Renal Cell Carcinoma
On December 13, 2017, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for priority review of nivolumab (Opdivo) plus ipilimumab (Yervoy) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma, as announced by Bristol-Myers Squibb. The FDA also previously granted Breakthrough Therapy Designation for this application, which is the second indication for which the nivolumab plus ipilimumab combination has received this designation.
The application is based on data from the phase III CheckMate-214 study, whose results were presented at the European Society for Medical Oncology 2017 Congress (Abstract LBA5). CheckMate-214 evaluated the combination of nivolumab plus ipilimumab versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma. The study met the co-primary endpoints of improved overall survival and objective response rate compared with sunitinib in intermediate- and poor-risk patients.
Adverse events leading to treatment discontinuation were reported in 22% of patients in the combination group, compared with 12% of patients in the sunitinib group. The most common adverse events in the combination group were fatigue (4%), diarrhea (4%), rash (2%), and nausea (2%). In the sunitinib group, the most common grade 3/4 adverse events were hypertension (16%), fatigue (9%), and palmar-plantar erythrodysesthesia syndrome (9%). There were seven treatment-related deaths in the combination group and four treatment-related deaths in the sunitinib group.