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European Commission Approves Opdivo with Cisplatin and Gemcitabine for First-Line Treatment of Advanced Urothelial Carcinoma | iPharmaCenter

Updated: May 30

The European Commission (EC) has granted approval for Opdivo (nivolumab) in combination with cisplatin and gemcitabine for first-line therapy in adult patients with unresectable or metastatic urothelial carcinoma (UC). This decision marks the first approval in the European Union (EU) for a combined immunotherapy and chemotherapy regimen for this patient group.


Basis of Approval: CheckMate -901 Trial

The approval is underpinned by results from the CheckMate -901 study, presented at the European Society of Medical Oncology (ESMO) Congress in 2023. This Phase 3 trial demonstrated that Opdivo combined with cisplatin and gemcitabine, followed by Opdivo monotherapy, significantly improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone. The safety profile was consistent with the known profiles of the individual drugs, with no new safety issues identified.


The EC’s approval of Opdivo with cisplatin and gemcitabine is supported by previous approvals for Opdivo, such as its use in adjuvant therapy for muscle-invasive urothelial carcinoma with PD-L1 expression ≥1% post-radical resection. Opdivo-based treatments are approved for various other cancers within the EU, including non-small cell lung cancer, melanoma, esophageal squamous cell carcinoma, and several others.


Key Findings from CheckMate -901

  • Overall Survival (OS): Patients receiving Opdivo with cisplatin and gemcitabine showed a 22% reduction in the risk of death, with median OS improving to 21.7 months compared to 18.9 months for cisplatin-gemcitabine alone (HR: 0.78; 95% CI: 0.63, 0.96; p=0.0171).

  • Progression-Free Survival (PFS): The combination therapy reduced the risk of disease progression or death by 28%, achieving a median PFS of 7.9 months versus 7.6 months for cisplatin-gemcitabine alone (HR: 0.72; 95% CI: 0.59, 0.88; p=0.0012).

  • Overall Response Rate (ORR): The ORR for the combination was 57.6% compared to 43.1% for chemotherapy alone.

  • Complete Response (CR) and Partial Response (PR) Rates: CR and PR rates for the combination were 22% and 36%, respectively, compared to 12% and 31% with cisplatin-gemcitabine alone.


CheckMate -901 is a Phase 3, open-label trial assessing Opdivo combined with Yervoy® (ipilimumab) or Opdivo with cisplatin and gemcitabine followed by Opdivo monotherapy, against standard chemotherapy in patients with untreated, unresectable, or metastatic UC. The study enrolled 608 patients eligible for cisplatin-based chemotherapy, who were randomized to receive either the combination therapy or chemotherapy alone. The primary endpoints were overall survival and progression-free survival.


Urothelial carcinoma, the predominant form of bladder cancer, originates in the lining cells of the bladder and can also affect the ureters and renal pelvis. Despite early diagnosis, recurrence rates are high, and about half of patients experience disease recurrence post-surgery, particularly within two to three years. Metastatic urothelial carcinoma has a poor prognosis, with median overall survival ranging from 12 to 14 months under systemic therapy.

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