EU Approves Opdivo Combo for First-Line Bladder Cancer

Bristol Myers Squibb has achieved a notable milestone with the second approval for its PD-1 immune checkpoint inhibitor, Opdivo (nivolumab). This approval, in combination with the chemotherapy drugs cisplatin and gemcitabine, is specifically for the first-line treatment of unresectable or metastatic urothelial carcinoma. This European Union decision follows a favorable opinion from the EU's drug advisory committee and arrives nearly three months after a similar approval in the United States. This marks the first simultaneous immunotherapy-chemotherapy regimen approved for this patient group in the EU.

The approval is grounded on results from the Phase III CheckMate-901 trial. This study compared the Opdivo regimen against standard chemotherapy in patients who had not received prior treatment. With a median follow-up duration of approximately 33 months, the combination therapy of Opdivo, cisplatin, and gemcitabine demonstrated a significant reduction in the risk of death by 22% compared to chemotherapy alone. The median overall survival for the Opdivo group was 21.7 months, in contrast to 18.9 months for the chemotherapy group.

Additionally, the Opdivo regimen resulted in a 28% reduction in the risk of disease progression or death, with a median progression-free survival of 7.9 months, compared to 7.6 months with chemotherapy. The overall response rate was notably higher at 57.6% for the Opdivo combination, compared to 43.1% for chemotherapy alone.

Insights from a FirstWord report, which involved interviews with a dozen key opinion leaders, shed light on Opdivo's future in bladder cancer treatment. While acknowledging the drug’s effectiveness in the adjuvant setting, as demonstrated by the Phase III CheckMate-274 trial, the experts emphasized that the expanding use of Opdivo in metastatic settings would hinge on identifying the best combinations with other novel immunotherapy or chemotherapy agents.

In the European Union, prior to this recent approval, Opdivo was sanctioned for adjuvant treatment in adults with muscle-invasive urothelial carcinoma who have PD-L1 expression levels of 1% or higher and are at high risk of recurrence after radical resection.

This latest approval solidifies Opdivo's role in the treatment landscape of urothelial carcinoma, offering a new therapeutic avenue that combines immunotherapy with chemotherapy. The significant improvements in overall survival, progression-free survival, and response rates underscore the potential benefits of this combination therapy for patients battling this challenging form of cancer. As research continues, further advancements and refinements in treatment combinations are anticipated, promising enhanced outcomes for patients in the future.