Opdivo (nivolumab) has been an increasingly successful drug in the oncology realm. As it stands right now, Opdivo is approved (either in combination with another therapy or as a monotherapy) for indications such as early-stage, advanced, or previously treated non-small cell lung cancer (NSCLC); advanced melanoma; advanced or metastatic renal cell carcinoma (RCC); and previously treated squamous cell carcinoma of the head and neck, among others. Now, shared Nick Paul Taylor in a March 2024 Biospace article, Opdivo has recently become FDA-approved in another indication: metastatic urothelial carcinoma.
The FDA approval of Opdivo, used in conjunction with cisplatin and gemcitabine, means that individuals living with metastatic or unresectable (not able to surgically remove) urothelial carcinoma now have a new treatment option. Some physicians believe that this medicine will vastly improve the way these patients are treated – while simultaneously improving outcomes.
The combination treatment’s approval follows data from a Phase 3 clinical study evaluating Opdivo, cisplatin, and gemcitabine compared to just cisplatin and gemcitabine alone. In data published in The New England Journal of Medicine, the researchers discuss how 608 patients were randomized into treatment. Findings from the study show that:
- The median overall survival rate was 21.7 months for people taking the Opdivo combination compared to 18.9 months for people taking just cisplatin and gemcitabine.
- Median progression-free survival was 7.9 months for the Opdivo cohort and 7.6 months for the cisplatin-gemcitabine cohort. At a 12-month follow-up, the researchers found that 34.2% of those receiving Opdivo remained progression-free, compared to 21.8% of those in the other group.
- The overall objective response – or how many people responded to the treatment – was 57.6% and 43.1% respectively, with a complete response of 21.7% vs. 11.8%. This shows significant benefits for the Opdivo-treated group.
Understanding Urothelial Carcinoma
Also known as: Bladder cancer
Previously known as: Transitional cell carcinoma
Urothelial carcinoma is a cancer that forms in the urothelial cells; these cells line the ureters, urethra, bladder, and renal pelvis. The cells mutate and grow out of control, forming a tumor. Metastatic urothelial carcinoma means that the cancer had spread (metastasized) from its initial site. While doctors don’t know what causes urothelial carcinoma, they have identified some risk factors. Certain chemical or medicine exposure, smoking, being Caucasian, being older in age, being male, or having chronic bladder infections can all heighten your risk.
People with urothelial carcinoma may experience symptoms or signs including:
- Hematuria (blood in the urine)
- Losing weight without trying
- Painful urination
- Fatigue
- Persistant back pain
- Swollen feet and ankles
- Low-grade fever
- A lump or mass in your kidney area
- Changes in urinary habits, such as urinating more or less frequently
- Appetite loss
- Inability to urinate
bladder cancer metastatic cancer metastatic urothelial carcinoma news oncology treatment urothelial carcinoma
Last modified: April 25, 2024
