FDA Approves Opdivo in Combination with Chemotherapy for First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma

Mar 08, 2024 07:43 CST Updated 07:43

Bristol-Myers Squibb

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On March 7, Bristol-Myers Squibb (BMS) Announces FDA Approval in the United StatesOpdivo(Nivolumab) in combinationCisplatinAndGemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.

This approval is based on the results of the Phase III CheckMate -901 clinical trial, which evaluated the treatment of Opdivo in combination with cisplatin and gemcitabine.This was followed by Opdivo monotherapy (n=304).vs. cisplatin-gemcitabine alone (n=304) for the efficacy and safety in previously untreated patients with unresectable or metastatic UC, with the primary efficacy endpoints being overall survival (OS) and progression-free survival (PFS).

In the trial, with a median follow-up of approximately 33 months, the Opdivo combination therapy group reduced the risk of death by 22%, with a median OS of 21.7 months compared to 18.9 months in the chemotherapy group (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171). Patients in the Opdivo combination therapy group had a 28% reduction in the risk of disease progression or death, with a median PFS of 7.9 months compared to 7.6 months in the chemotherapy group (HR 0.72; 95% CI:0.59, 0.88；p=0.0012）。

Moreover, in exploratory analyses, the objective response rate (ORR) was 57.6% (n=175) (95% CI: 51.8, 63.2) in the Opdivo combination therapy group compared to 43.1% (n=131) (95% CI: 37.5, 48.9) in the chemotherapy group. The complete response (CR) and partial response (PR) rates were 22% (n=66) and 36% (n=109), respectively, in the combination therapy group, versus 12% (n=36) and 31% (n=95), respectively, in the chemotherapy group.

UC is the 10th most common cancer worldwide, with more than 573,000 patients diagnosed annually.UCIt usually originates from the cells inside the bladder and accounts for about 90% of bladder cancers. Apart from the bladder,UCIt may also occur in other parts of the urinary tract, including the ureter and renal pelvis. MostUCCan be diagnosed early, but approximately 50% of patients who undergo surgery will experience disease progression and recurrence within 2-3 years after the operation. About 20%-25% ofUCPatients will develop metastatic disease. The therapeutic effect of chemotherapy alone as a first-line treatment is not durable enough, which is unfavorable for the treatment of metastatic UC, and in advanced stages...UCThe patient has limited second-line treatment options.

ForUC Indications,The FDA previously approved Opdivo for adjuvant treatment of adult UC patients at high risk of recurrence after radical UC surgery; Opdivo was also previously approved for the treatment of adult patients with locally advanced or metastatic UC whose disease progressed during or after platinum-containing chemotherapy, or who experienced disease progression within 12 months after neoadjuvant or adjuvant platinum-containing chemotherapy.。

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