Non-Muscle Invasive Bladder Cancer (includes Ta, T1, CIS tumors) , Muscle Invasive Bladder Cancer (includes T2 tumors) , Ta or CIS: Can include both low and non-muscle invasive, high grade non-muscle invasive bladder cancer (NMIBC), or Carcinoma in Situ (CIS)

Immunotherapy

Immunotherapy

Indication #1:

• Adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC).

Indication #2:

• Adult patients with muscle invasive bladder cancer (MIBC).

For Non-muscle Invasive Bladder Cancer:

• IMFINZI (durvalumab) is a monoclonal antibody that binds to the PD-L1 protein, blocking its interaction with PD-1 and CD80. This blockade removes the inhibition of immune responses, working with your immune system to help attack the cancer cells.

For Muscle Invasive Bladder Cancer:

• IMFINZI binds to the PD-L1 receptor to block the PD-L1/PD-1 pathway, which releases the inhibition of immune responses and allows the body’s immune system to attack the cancer cells

For Non-muscle Invasive Bladder Cancer:

• It is used in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance treatment. Patients receive IMFINZI every 4 weeks for up to 13 cycles, alongside BCG induction every week for 6 weeks, followed by BCG maintenance on a weekly basis for 3 weeks at 3, 6, 12, 18, and 24 months.

For Muscle Invasive Bladder Cancer:

• It is used in a two-part regimen surrounding the surgical removal of the bladder (radical cystectomy). First, it is used as neoadjuvant treatment in combination with gemcitabine and cisplatin chemotherapy for 4 cycles prior to surgery. Following surgery, it is continued as a single-agent adjuvant treatment for up to 8 cycles.

For Non-muscle Invasive Bladder Cancer:

• IMFINZI is administered as an intravenous (IV) infusion over 60 minutes. BCG is administered directly into the bladder as an intravesical instillation.

For Muscle Invasive Bladder Cancer:

• IMFINZI and the chemotherapy agents are administered as intravenous (IV) infusions. IMFINZI is infused over 60 minutes.

For Non-muscle Invasive Bladder Cancer:

• The most common side effects (affecting 20% or more of patients) include increased glucose, increased liver enzymes (AST, ALT, GGT), increased lipase, urinary tract infections, increased potassium, painful urination (dysuria), decreased hemoglobin, blood in the urine, increased serum creatinine, musculoskeletal pain, decreased lymphocytes, frequent urination, decreased sodium, fatigue, rash, and fever

For Muscle Invasive Bladder Cancer:

• The most common side effects (affecting 20% or more of patients) are decreased hemoglobin, decreased neutrophils and lymphocytes (white blood cells), increased blood creatinine, decreased sodium, nausea, increased liver enzymes (ALT, AST), decreased calcium, decreased platelets, fatigue, increased potassium, constipation, decreased magnesium, decreased appetite, increased alkaline phosphate, rash, fever, diarrhea, vomiting, and abdominal pain