Bristol Myers announces EC approves Opdivo combination

Bristol Myers Squibb announced that the European Commission, or EC, has approved Opdivo, or nivolumab, in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma, or UC. With this approval, Opdivo in combination with cisplatin and gemcitabine becomes the first concurrent immunotherapy-chemotherapy approved for the treatment of adult patients with unresectable or metastatic UC in the first-line setting in the European Union. The EC’s decision is based on results from the CheckMate -901 trial studying Opdivo in combination with cisplatin and gemcitabine, which were presented at the European Society of Medical Oncology, or ESMO, Congress 2023. In CheckMate -901, Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival, or OS, and progression-free survival, or PFS, compared to chemotherapy alone, as assessed by Blinded Independent Central Review, or BICR. The safety profile was consistent with the known safety profiles of the individual components of the regimen. No new safety concerns were identified. Opdivo in combination with cisplatin and gemcitabine reduced the risk of death in patients by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone. Risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone.