Nivolumab has recently received an additional indication for the treatment of urothelial carcinoma with a high risk for recurrence following radical resection, a form of bladder cancer. This decision came after the evaluation of data from the CheckMate-247 trial. Patients and medical professionals alike are excited by this development, as nivolumab may offer a new standard of care for urothelial carcinoma patients.
Nivolumab for Urothelial Carcinoma
Bristol-Meyers Squibb (BMS), the drug’s maker, recently announced the new indication. They are excited to expand nivolumab’s reach, as it was previously only indicated for metastatic or advanced urothelial carcinoma.
Nivolumab, which is a PD-1 inhibitor, was evaluated in the CheckMate-247 trial, which led the FDA to grant adjuvant approval. 709 patients were randomized to receive either nivolumab or a placebo; the nivolumab group received 240 mg administered via IV every two weeks. One of the most exciting data points was median disease-free survival (DFS), which nearly doubled with nivolumab in comparison to a placebo. Further results include:
- Median DFS of 20.8 months in the nivolumab group
- Median DFS of 10.8 months in the placebo group
- 30% of the nivolumab group experienced serious adverse effects (AEs)
- Most common AE was a urinary tract infection (UTI)
- 1% of the nivolumab group experienced a fatal reaction
About Urothelial Carcinoma
Urothelial carcinoma (UC) is the most common form of bladder cancer in the United States, and it forms in the urothelial cells of the bladder, ureter, and urethra. Males over the age of 55 are at the highest risk of this cancer. Additional risk factors include smoking, a family history of bladder cancer, chronic bladder inflammation, exposure to certain chemicals like arsenic, and prior cancer treatment. When one has UC, they will experience symptoms such as:
- Painful urination
- Blood in the urine
- Back pain
- Frequent urination
There are a number of treatment options, including radiation, surgery, targeted therapy, immunotherapy, intravesical chemotherapy, and systemic chemotherapy. Doctors will decide which option or combination of options to use based on overall health, patient preferences, and cancer grade and stage.
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