In August 2021, the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) for the adjuvant treatment of a rare form of cancer called urothelial carcinoma. More particularly, the drug is targeted towards patients who underwent radical resection but were still at an increased risk of cancer recurrence. The approval hinged on data from the Phase 3 CheckMate 274 study, which sought to understand the long-term benefits of nivolumab within this patient population; at the time of approval, the data included a minimum follow-up period of 5.9 months. More recently, an article in OncLive speaks with Dr. Matthew Galsky, MD about new findings from a longer follow-up period, as well as potential future research.
Dr. Galsky, who presented this follow-up data at a recent meeting, explains that the study compared nivolumab to a placebo in people with muscle-invasive urothelial carcinoma. Altogether, 353 patients participated. The study had a median follow-up of 36.1 months. Findings from the study include:
- In those whose PD-L1 expression was at least 1%, nivolumab improved disease-free survival from 8.4 months (in the placebo group) to 52.6 months.
- When looking at the entire population of patients with muscle-invasive urothelial carcinoma, nivolumab contributed to disease-free survival of 22 months compared to placebo (10.9 months). Nivolumab also improved progression-free survival.
- No new safety signals were observed when examining the follow-up data.
Nivolumab: A Brief Overview
So what exactly is nivolumab? Marketed under the brand name OPDIVO, nivolumab is described by the National Cancer Institute (NCI) as being:
a fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1…which results in the activation of T cells and cell-mediated immune responses against tumor cells.
Outside of urothelial carcinoma, nivolumab is also approved to treat Hodgkin’s lymphoma, colorectal cancer, renal cell carcinoma, esophageal cancer, gastric cancer, gastroesophageal junction adenocarcinoma, melanoma, malignant pleural mesothelioma, non-small cell lung cancer, and squamous cell carcinoma of the head and neck.
What is Urothelial Carcinoma?
Also known as bladder cancer or transitional cell carcinoma, urothelial carcinoma begins in the urothelial cells that line the bladder, urethra, ureters, and renal pelvis. Although urothelial carcinoma is rare, it is also considered one of the most common forms of bladder cancer. The exact cause of urothelial carcinoma is unknown, though risk factors have been identified. These risk factors include older age, being Caucasian, having a personal history of bladder cancer, chronic bladder infections, being male, certain medication use, smoking, chemical and substance exposure, and arsenic in drinking water. Symptoms vary from person-to-person but may include:
- Hematuria (blood in the urine)
- Painful urination
- Changes in urinary urgency or frequency
- Bone pain
- Appetite loss
- Swollen feet
- Unintentional weight loss
- Back and abdominal pain (with the back pain affecting one side of the lower back)
- Fatigue and general weakness
- Inability to urinate
There are a number of potential treatment options for urothelial carcinoma, such as chemotherapy, intravesical therapy, radiation, surgery, targeted therapy, and immunotherapy.