FDA Grants Approval for Nivolumab Plus Cisplatin and Gemcitabine for Unresectable or Metastatic Urothelial Carcinoma in First-Line Setting

The US Food and Drug Administration (FDA) has granted approval of nivolumab plus cisplatin and gemcitabine for the treatment of patients with unresectable or metastatic urothelial carcinoma in the first-line setting.

This regulatory decision was based on the results from the phase 3 CheckMate 901 trial. This open-label trial randomized 608 patients on a 1-to-1 basis to receive either nivolumab plus cisplatin and gemcitabine for up to 6 cycles followed by nicolumab alone for up to 2 years, or cisplatin and gemcitabine for up to 6 cycles. In both cycles, patients who discontinued cisplatin were allowed to receive carboplatin. The major outcome measures were overall survival (OS) and progression-free survival (PFS).

In the nivolumab arm, both the OS and PFS showed a statistically significant improvement, compared to the chemotherapy alone arm. The median OS was 21.7 months in the nivolumab arm vs 18.9 months in the chemotherapy alone arm (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.63 to 0.96; 2-sided P = .0171). The median PFS was 1.9 months and 7.6 months respectively (HR, 0.72; 95% CI, 0.59 to 0.88; 2-sided P = .0012).

The most common adverse events occurring in >15% of patients in the nivolumab arm were nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, peripheral neuropathy, urinary tract infection, diarrhea, edema, hypothyroidism, and pruritis.

The recommended dose for nivolumab in this patient population is 360 mg every 3 weeks in combination with cisplatin and gemcitabine every 3 weeks for up to 6 cycles, followed by 240 mgevery 2 weeks or 480 mg every 4 weeks as a monotherapy until disease progression, unacceptable toxicity, or up to 2 years from the first dose.

Source:

FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma. Published March 7, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-combination-cisplatin-and-gemcitabine-unresectable-or-metastatic-urothelial