Ongoing Clinical Trials in Muscle-Invasive Bladder Cancer

EP: 1.Case Overview: A 75-Year-Old Woman with High-Risk Muscle Invasive Bladder Cancer

EP: 2.Standard of Care for Muscle-Invasive Bladder Cancer

EP: 3.Adjuvant Nivolumab for High-Risk Muscle-Invasive Bladder Cancer

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EP: 4.Ongoing Clinical Trials in Muscle-Invasive Bladder Cancer

EP: 5.The Future of Treatments for Muscle Invasive Bladder Cancer

Karim Chamie, MD: Patients with muscle-invasive bladder cancer have access to numerous clinical trials. As we progress into earlier stages of disease, some of the drugs that have been used for patients with muscle-invasive metastatic 2nd-line, 3rd-line settings are now being advanced into the neoadjuvant setting. We have the KEYNOTE-866 study, which is pembrolizumab plus chemotherapy. We have the KEYNOTE-B15 study, which is pembrolizumab plus enfortumab vedotin. We have clinical trials of chemotherapy plus nivolumab, plus or minus IDO inhibitors. We have nivolumab plus NKTR-214, which is a pegylated IL2 agent. We have chemotherapy plus nivolumab, plus or minus IDO inhibitors. We have nivolumab plus ipilimumab. We have additional drugs that were tested in 2nd and 3rd-line settings that are being moved up to the neoadjuvant study. This is a really exciting period for physicians who treat patients with bladder cancer and patients who have recently been diagnosed with bladder cancer as far as the options they have now compared to what they had 5, 10 years ago.

Now, as far as adjuvant treatments, there are also some exciting studies. The IMvigor011 study is adjuvant atezolizumab in those that have circulating tumor DNA. As you recall, the IMvigor010 was negative based on an intent to treat. However, when they actually did a subset analysis of patients who has circulating tumor DNA positivity, those patients benefited significantly as far as recurrence-free survival. I expect to have data being presented in the next couple years where we're probably going to see similar benefits in patients who are getting atezolizumab in the adjuvant setting amongst those that have circulating tumor DNA positivity.

Transcript edited for clarity.

Case: A 75-Year-Old Woman with High-Risk Muscle Invasive Bladder Cancer

Initial presentation

• A 75-year-old woman with gross painless hematuria in August 2020

Patient history

• Diabetes and hypertension, both of which are managed with medications
• Current smoker 10 pack/year
• ECOG PS 0
• No family history of bladder cancer

Clinical workup and imaging

• eGFR 56 mL/min
• Patient undergoes TURBT and is found to have muscle invasive bladder cancer (MIBC)
• Patient undergoes chest, abdominal and pelvic imaging and a 1 cm external iliac lymph node is identified
• Clinical stage T3N1M0 urothelial carcinoma

Treatment

• Patient undergoes neoadjuvant treatment with gemcitabine + cisplatin for 4 cycles, followed by radical cystectomy in Jan. 2021.
• Patient undergoes imaging and lab work to monitor for disease progression.